Responsiveness of outcome measures for upper limb prosthetic rehabilitation.

554032 research-article2014

POI0010.1177/0309364614554032Prosthetics and Orthotics InternationalResnik and Borgia

INTERNATIONAL SOCIETY FOR PROSTHETICS AND ORTHOTICS

Original Research Report

Prosthetics and Orthotics International 1–13 © The International Society for Prosthetics and Orthotics 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0309364614554032 poi.sagepub.com

Responsiveness of outcome measures for upper limb prosthetic rehabilitation Linda Resnik and Matthew Borgia

Abstract Background: There is limited research on responsiveness of prosthetic rehabilitation outcome measures. Objectives: To examine responsiveness of the Box and Block test, Jebsen–Taylor Hand Function tests, Upper Extremity Functional Scale, University of New Brunswick skill and spontaneity tests, Activity Measure for Upper Limb Amputation, and the Patient-Specific Functional Scale. Study design: This was a quasi-experimental study with repeated measurements in a convenience sample of upper limb amputees. Methods: Measures were collected before, during, and after training with the DEKA Arm. Results: Largest effect sizes were observed for Patient-Specific Functional Scale (effect size: 1.59, confidence interval: 1.00, 2.14), Activity Measure for Upper Limb Amputation (effect size: 1.33, confidence interval: 0.73, 1.90), and University of New Brunswick skill test (effect size: 1.18, confidence interval: 0.61, 1.73). Other measures that were responsive to change were Box and Block test, Jebsen–Taylor Hand Function light and heavy can tests, and University of New Brunswick spontaneity test. Responsiveness and pattern of responsiveness varied by prosthetic level. Conclusions: The Box and Block test, Jebsen–Taylor Hand Function light and heavy can tests, University of New Brunswick skill and spontaneity tests, Activities Measure for Upper Limb Amputation, and the Patient-Specific Functional Scale were responsive to change during prosthetic training. These findings have implications for choice of measures for research and practice and inform clinicians about the amount of training necessary to maximize outcomes with the DEKA Arm. Clinical relevance Findings on responsiveness of outcome measures have implications for the choice of measures for clinical trials and practice. Findings regarding the responsiveness to change over the course of training can inform clinicians about the amount of training that may be necessary to maximize specific outcomes with the DEKA Arm. Keywords Responsiveness, prosthetics, upper limb, amputation, disability evaluation, assistive technology Date received: 21 March 2014; accepted: 26 August 2014

Background Systematic tracking and evaluation of outcome measures can be used to assess treatment effectiveness, monitor function, and assess value of rehabilitation services for persons with upper limb amputation. Measurement of functional status during rehabilitation is increasingly valued by health-care providers, researchers, policy makers, and the payer community. Evaluation of treatment outcomes is a basic tenet of evidence-based care.1 Studies of treatment efficacy and comparative effectiveness are often predicated on use of measures that assess important domains in a scientifically sound way. Measurement of outcomes is needed to evaluate effectiveness of

interventions as well as the necessary dosage and timing of treatment. In 2013, the Center for Medicare and Medicaid Services (CMS) implemented a mandatory functional status reporting system for outpatient therapy services for Medicare patients. Functional outcomes assessment is included as Providence VA Medical Center, Providence, RI, USA Corresponding author: Linda Resnik, Providence VA Medical Center, 830 Chalkstone Ave, Providence, RI 02908, USA. Email: [email protected]

Downloaded from poi.sagepub.com at Apollo Group - UOP on February 17, 2015

2

Prosthetics and Orthotics International

part of Physician Quality Reporting System (PQRS) for Medicare patients.2 Unlike inpatient rehabilitation, settings that use CMS-prescribed data elements for prospective payment, in the Medicare reporting systems providers choose the measure of function that they feel is most appropriate for their patients. For these reasons, it is critical that research be conducted to provide clinicians and researchers with the data to guide selection and interpretation of outcome measures. Leaders in upper limb prosthetic rehabilitation understand the importance of choosing outcome measures that have been evaluated for persons with upper limb amputation and that are reliable, valid, and responsive to change.3–6 However, limited research on measurement properties of existing measures and lack of measures that assess important domains have created challenges for the field.6–10 Our group has conducted several studies to examine measurement properties of the measures utilized in the Department of Veterans Affairs (VA) Study to Optimize the DEKA Arm. 11,12 We also designed and tested a new measure to fill the gap in activity performance measures for adults with upper limb amputation. 13 We reported test–retest reliability of the Box and Block Test of Manual Dexterity (BB), 14–16 the Jebsen–Taylor Hand Function (JTHF) test, 17 the Activities Measure for Adults with Upper Limb Amputation (AM-ULA), 11 the University of New Brunswick (UNB) measure of prosthetic skill and spontaneity,11 and two self-report measures of function, the Upper Extremity Functional Scale (UEFS), 9,18 and the Patient-Specific Functional Scale (PSFS).19 We also examined inter-rater reliability of all performance measures rated by clinicians,11 and known group validity of the UNB 11 measure and AM-ULA.11 However, we have not yet reported on measure responsiveness to change during prosthetic training. Therefore, the purpose of this study was to examine responsiveness of outcome measures utilized in the VA Study to Optimize the DEKA Arm. We aimed to (1) compare responsiveness of measures; (2) determine whether responsiveness varied by level of prosthesis, and (3) examine whether measures plateaued or continued to improve over the course of training. We hypothesized that the majority of measures would be responsive to training, and that responsiveness would vary by prosthetic level and amount of training.

Methods This was a multi-site study with repeated measurements of subjects. Data were collected at four sites: Department of Veterans Affairs New York Harbor Health Care System (VA NYHHS), James Haley VA, Long Beach VA, and Center for the Intrepid. The study received Institutional Review Board approval at all study sites.

Sample Subjects were a convenience sample of upper limb amputees participating in the VA Study to Optimize the DEKA Arm.20 Subjects were eligible if they were at least 18 years old and had single or bilateral transradial, transhumeral, shoulder disarticulation or forequarter level amputation. Subjects were excluded if they had significant uncorrectable visual deficits, major communication or neurocognitive deficits, skin conditions prohibiting prosthetic wear, or had an electrically controlled medical device. Subjects were enrolled based upon their availability, availability of a DEKA Arm at the necessary level, and the desire to balance the sample by amputation level and gender. Subjects were recruited by clinicians, emails, press releases, flyers, and brochures. All were trained to utilize the DEKA Arm, a pre-commercial upper limb prosthetic prototype, funded by the Defense Advanced Research Projects Agency (DARPA) Revolutionizing Prosthetics Program.21 The DEKA Arm comes in three configurations, or levels: the radial configuration (RC), used for transradial amputees; the humeral configuration (HC), used for transhumeral amputees; and the shoulder configuration (SC), used for persons with forequarter amputation, shoulder disarticulation, or very short transhumeral amputation. The SC DEKA Arm has 10 degrees of powered movement. All levels have six pre-programmed handgrips and are operated by a combination of methods that may include foot controls, optional EMGs, pressure switches, or other commonly available prosthetic input elements. A detailed description of the DEKA Arm and its features can be found elsewhere.21

Training to use the DEKA Arm Subjects were oriented to the device features and controls through an interactive Virtual Reality Environment (VRE) program22 and then trained by the study therapists using a standardized protocol, described in detail elsewhere.23 An overview of the training protocol is shown in Table 1. The first step in training process is prosthetic fitting and basic controls set-up. During this phase, the prosthetist and user determine the initial control scheme that the prosthetist will use to configure the DEKA Arm.The subject then practices activating each control and identifying the associated action until it is clear that he or she clearly understands the control for each Arm action. A picture of the controls is created and given to the user, who is instructed to review the controls handout each night until he or she demonstrates consistent memory recall for device control. The next segment within the training protocol is pre-prosthetic training, which includes instruction about the features of the device and simulated use of the DEKA Arm within a VRE. When VRE training is complete and the user is comfortable with basic operations, training with the activated DEKA Arm begins.



•• Name/explain all parts of device, functions, movements •• All activities included in RC training

•• All activities included in RC training •• Emphasize safe movements: (hand away from face/head— FORWARD Command) and elbow positioning in UP/ DOWN commands to keep arm away from head and face •• All activities included in RC training •• Review using a spoon, drinking from a cup, and the ROM of SC (functional window)

•• Name/explain all parts of device, functions, movements •• All activities included in RC training •• All activities included in RC training

•• All activities included in RC training

•• Name/explain all parts of device, functions, movements

•• 5–15 min guiding user to learn what each foot movement or other control site does •• Have user demonstrate with sound hand (if a unilateral amputee)

•• User activates controls to operate avatar for basic activities and grips

•• User activates controls to operate avatar for simulated scenarios including hand to mouth, raising arm overhead; uses foot controls with feet elevated

Vocabulary/basic knowledge of arm functions

Memory drills without controls activation

Control drills operating the avatar

Complex movements with the avatar

•• All activities included in RC training •• Emphasize safe movements: (hand away from face/head— FORWARD Command) and elbow positioning in UP/ DOWN commands to keep arm away from head and face


•• Review controls at the start of each day’s session in sitting and standing •• Sessions progress from basic knowledge review and pre-task training to simple grasp/release activities, to more complex unilateral and bilateral tasks, including user-requested activities, to supervised community outings

General (overview)

(Continued)

•• 20–30 h of training

•• 20 h of training

•• 20 h of training

Training time (overview)

Training with DEKA Arm

•• 4 h minimum •• All activities included in RC training

•• 2 h minimum •• All activities included in RC training

•• 2 h minimum


SC

•• Arm is de-activated during VRE with user focusing on VRE avatar, not the actual arm •• Control set-up visual handout should initially be displayed, then removed if user is able to recall control scheme •• Control drills are performed in standing and sitting positions


HC

General information

•• Prosthetist configures and explains controls to user; user demonstrates activation of each control •• OT provides user a visual picture of control set-up and encourages daily review

RC

Overall tips

VRE training

Setup and intro to controls

Prosthetic fitting/basic controls training

Training component

Table 1. Comparison of training protocol by level of DEKA Arm.

Resnik and Borgia 3


•• User performs with assistance in early sessions, independently as soon as possible, with assistive devices if needed

Donning and doffing






•• OT reinforces use of DEKA Arm as a “functional assist”; perform bilateral ADL from required activities checklist •• OT attends to body posture and prosthetic positioning; coaches user to avoid compensatory movements

•• Include performance of short-term projects, vocational and recreational tasks, such as games, cooking, eating, sports •• Include activities chosen by user •• Allow some time in each session for user to operate arm without instruction

Bilateral ADL tasks

Advanced training

OT: Occupational Therapist; RC: radial configuration; SC: shoulder configuration; IMU: inertial measurement unit; VRE: virtual reality environment; VEP: voluntary elbow positioning; ADL: activities of daily living; HC: humeral configuration; ROM: range of motion; EMG: myoelectrode.



•• Begin after user can control prosthetic movements in a natural way, usually by third session •• Perform unilateral ADL from required activities checklist •• OT attends to body posture and prosthetic positioning; coaches user to avoid compensatory movements whenever possible

Unilateral ADL tasks

Training activities

•• All activities included in RC training plus explore functional window during activities such as shadow boxing


•• User grasps and releases objects midline on table using different grips; using form board; stacking plastic cups/cones/blocks; shadow boxing

Grasp and release training




•• User verbalizes each control as she or he performs all movements; quiz user on controls

•• All activities included in RC training •• Perform six Endpoint movements and two VEP elbow movements •• Hand to mouth sequence •• Review safe operation near head

•• All activities included in RC training •• Perform four movements of elbow

•• OT reviews all user notifications, safe use, manual release of hand, check battery levels, battery charging and changing, perform each wrist control, open/close hand, and each grip quizzes on grip order, quizzes on best grip for specific activities

Reinforce control schemes

Drills

•• All activities included in RC training •• Identify mode select

SC

•• All activities included in RC training •• Identify mode select

HC

•• User names all arm components, identify off/on, standby, tactor, all prosthesis movements, and all control movements (IMUs, EMGs, bladder)

RC

Basic knowledge

Basic arm knowledge

Training component

Table 1. (Continued)

4 Prosthetics and Orthotics International

5

Resnik and Borgia Training with the DEKA Arm itself began with reinforcement of prosthetic control patterns of motions, control mechanisms, and safety features. Training progresses from simple movement activation drills and grasp and release activities to performance of increasingly complex unilateral and bilateral activities such as opening a door with a knob, cutting meat with knife and fork, folding a bath towel, and reaching overhead to grasp an object. Training sessions also included practice of a required list of activities which were identical to items in the UEFS measure. As training progressed, less time was spent on controls training and grasp and release activities and more focus was directed to activities of daily living (ADL) as well as advanced unilateral and bimanual activities. Advanced training included performance of shortterm projects, such as preparing a simple meal, specific recreational tasks or games of the subject’s choosing such as putting a golf ball, or completing a model-building project. Training sessions also included time to use the DEKA Arm without any instruction, but still under close supervision by the therapist. For most subjects, this progression of training took place over the course of 10 2-h sessions. Partway through the study, the training protocol was adapted for SC subjects by adding five additional training visits (10 h) to allow this group of amputees more time to master the more complex SC device. Of the 14 people using an SC Arm, eight completed 15 training visits.

Data collection Outcome measures were administered at the onset of training, after five training visits (10 h of training) and at final testing (18 h of training or more). All performance-based tests were administered by Occupational Therapists (OTs). The dexterity tests were administered by OTs and timed by research assistants. OTs were trained in the test administration methods by the first author. Performance measures were scored at the time of data collection analysis.11,13 Subjects completed self-report measures by paper and pencil.

Measures

including (1) printing a 24-letter, third-grade reading difficulty sentence, (2) turning over 7.6 × 12.7 cm (3 × 5) cards in simulated page turning, (3) picking up small common objects (including pennies, paper clips, bottle caps) and placing them in a container, (4) stacking checkers, (5) simulated feeding, (6) moving large empty cans, and (7) moving large 1 lb cans. Each subtest is scored separately. We modified the test administration and scoring method by capping the maximal allowable time for each subtask at 2 min. The score was calculated as the number of items completed per second. Therefore, completing more items per second indicated better function. Test–retest reliability for JTHF test components was 0.68–0.92, with the number of checkers/second test having the lowest intraclass correlation coefficient (ICC) of 0.68 (confidence interval (CI): 0.49–0.80).12 AM-ULA. It is an 18-item measure that assesses functional performance with a prosthesis: the ability of the amputee to complete daily activities, the speed of the performance, the movement quality, skillfulness of prosthetic use, and independence.13 Higher AM-ULA scores indicate better performance. The AM-ULA has excellent test–retest reliability, inter-rater reliability, internal consistency, and demonstrated known group validity.13 UNB Test of Prosthetic Function for Unilateral Amputees. It includes a spontaneity of prosthetic use (Spontaneity) and a skillfulness of prosthetic use (Skill.) scale.24 Higher scores indicate better performance. We used a subtest of the UNB designed for 11–13 year olds11 that included wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, and sweeping floors. Analyses of the UNB test found that the subtests had acceptable internal consistency, test–retest and inter-rater reliability, and preliminary evidence of validity.11 UEFS. It is from the Orthotics and Prosthetics Users Survey (OPUS).9,18 The UEFS items ask clients to evaluate the ease of performing 23 activities, including selfcare and instrumental daily living tasks, using a 5-point scale from “1” very easy to “5” cannot perform. We used a modified 22-item version of the UEFS, omitting the one item related to washing and recalibrated the scores using WINSTEPS. Lower scores indicated higher functioning. Test–retest reliability of the modified UEFS was 0.80.12

The following measures were utilized: BB.14–16 It consists of a box with a center partition. Small wooden blocks were placed in one side of the box and the subject was asked to use the device to grasp one block at a time, transport it over the partition, and release it. The number of blocks transported to the other side in 60 s was counted. Therefore, transporting more boxes indicated better dexterity. Test–retest reliability of the BB was 0.91.12 JTHF test.17 It is a seven-part dexterity test that evaluates the time needed to perform seven hand-related tasks

The UEFS questionnaire also asks respondents to indicate whether or not they usually perform each of the activities using their prosthesis (or orthosis). We scored the UEFS Use scale by calculating the proportion of activities that the subject indicated that they performed using the prosthesis. To increase the validity of self-report, we collected the UEFS after subjects had attempted to perform all activities in the measure. Thus, we did not gather it at baseline testing with the DEKA Arm, only at 10 of training and final testing.


6

Prosthetics and Orthotics International PSFS. It asks subjects to identify up to five activities that they have difficulty performing due to their condition.19 Subjects then rated the amount of limitation they have in performing these activities on a scale of 0–10, with “0” being unable to perform the activity and “10” being able to perform the activity with no problem. Therefore, higher scores indicate better functioning. Individual items were scored separately.

Statistical analyses Descriptive analyses examined the mean and standard deviation (SD) of scores for each outcome measure using matched subject data for each testing period. We calculated the effect sizes (ESs) which are the difference of two means divided by an estimate of the SD (the pooled SD in this case) for the population with 95% CIs for each outcome measure. In our calculations, we used data from the entire sample and then repeated the calculations, stratified by level of amputation. To determine responsiveness of measures over the course of prosthetic training, we examined ES from baseline to 20-h training, from baseline to 10-h training, and from 10-h training to final testing. An ES of 0.80 was considered large, 0.50 moderate, and 20 h

Mean (SD)

Mean (SD)

Box and Block 32 Jebsen–Taylor (#items/s) 31 Writing Page turning 31 Small items 31 Feeding 31 31 Checkers Light cans 31 Heavy cans 31 UNB skill 29 UNB spontaneity 29 27 AM-ULA 0 UEFS UEFS Use 0 31 PSFS

3.91 (4.32)

8.56 (5.78)

0.25 (0.23) 0.03 (0.04) 0.04 (0.06) 0.05 (0.06) 0.05 (0.06) 0.09 (0.09) 0.11 (0.10) 2.49 (0.76) 2.86 (0.79) 1.71 (0.53) NA NA 2.90 (1.45)

0.35 (0.17) 0.05 (0.04) 0.05 (0.04) 0.07 (0.06) 0.06 (0.05) 0.16 (0.10) 0.17 (0.09) 3.25 (0.49) 3.56 (0.44) 2.32 (0.38) NA NA 5.57 (1.88)

N

Comparison of baseline and 10-h training

Comparison of 10 hours of training and final testing

N

N

Baseline

10 h

Mean (SD)

Mean (SD)

37

4.27 (4.23)

7.89 (5.49)

36 36 36 36 36 36 36 33 33 32 0 0 36

0.26 (0.24) 0.03 (0.04) 0.04 (0.06) 0.05 (0.06) 0.04 (0.06) 0.09 (0.09) 0.11 (0.10) 2.43 (0.79) 2.81 (0.80) 1.67 (0.55) NA NA 2.91 (1.42)

0.34 (0.21) 0.04 (0.04) 0.05 (0.05) 0.05 (0.05) 0.05 (0.04) 0.12 (0.09) 0.13 (0.10) 2.90 (0.60) 3.33 (0.57) 2.11 (0.45) NA NA 4.03 (2.03)

10 h

>20 h

Mean (SD)

Mean (SD)

32

7.91 (5.63)

8.56 (5.78)

32 32 32 32 32 32 32 30 30 28 32 32 32

0.34 (0.22) 0.04 (0.04) 0.05 (0.05) 0.05 (0.06) 0.05 (0.05) 0.13 (0.09) 0.14 (0.11) 2.99 (0.56) 3.39 (0.55) 2.21 (0.45) 43.49 (7.58) 0.70 (0.36) 3.70 (1.85)

0.34 (0.17) 0.06 (0.04) 0.06 (0.05) 0.07 (0.06) 0.06 (0.05) 0.16 (0.10) 0.17 (0.09) 3.27 (0.50) 3.58 (0.44) 2.37 (0.46) 41.84 (7.05) 0.84 (0.27) 5.58 (1.85)

SD: standard deviation; UNB: University of New Brunswick; AM-ULA: Activities Measure for Upper Limb Amputation; UEFS: Upper Extremity Functional Scale; PSFS: Patient-Specific Functional Scale.

ES (CI: −0.28, 1.42) after 10 h of training. The PSFS had a large ES between baseline and 10 h training for RC users but not for other levels (ES: 1.03, CI: 0.11, 1.88), and a large ES for SC users between 10 h and final testing for SC users, but not for other levels (ES: 1.17, CI: 0.34, 1.93).

Discussion We examined the ability of a set of outcome measures to measure functional change in upper limb amputees after occupational therapy training to utilize the DEKA Arm. Ours is the first study of its kind to evaluate responsiveness of measures of upper limb prosthetic rehabilitation. We found that for all prosthetic levels combined, the BB, JTHF light and heavy can tests, UNB skill and spontaneity tests, AM-ULA, and PSFS were responsive to change. However, the remaining JTHF tests and the UEFS were not responsive. Some of the differences we observed in responsiveness of measures by type of DEKA Arm may be attributable to the differing complexity of learning to use each configuration. Users of the RC DEKA Arm must memorize and utilize controls for 6 degrees of freedom (hand open/ close, wrist flexion/extension, and wrist pronation/supination in addition to the control for grip selection. In contrast, users of the HC Arm must learn to utilize these same controls plus controls for elbow flexion/extension, humeral internal/external rotation, as well as a mode selection to switch between hand/wrist movements and arm movements. Finally, users of the SC Arm had the

greatest number of controls to master, as they must learn to control the hand/wrist movements, elbow in and out, as well as six Endpoint control movements (up/down, forward/backward, left/right). Generally speaking, dexterity measures were more responsive to change in SC users than in RC and HC users. This may be because RC and HC users were able to master the basic controls necessary to perform the dexterity tests during VRE and brief exposure to live training, which happened prior to initial testing. Therefore, training had little to no impact on dexterity. However, SC users, who had to learn to operate a more complex set of controls, required additional training to maximize dexterity. There may be a similar explanation for the finding that prosthetic spontaneity and activity performance, as measured by the UNB spontaneity and AM-ULA tests, did not significantly improve after baseline testing for RC subjects. Another explanation is that RC users had higher scores on tests of spontaneity and activity performance with their existing prostheses as compared to SC and HC users (findings reported elsewhere).26 Because they were already accustomed to utilizing a prosthesis in bilateral and everyday tasks, there was less room for improvement. Our study provided interesting information about the timing of gains made in dexterity and activity performance over time for each level of DEKA Arm user. Users of all levels achieved greater change in dexterity (Box and Block), skill, and activity performance in the first 10 h of training than they did in the second 10 h (as indicated by bigger ES of measures). This finding suggests


8


Figure 1. Effect size and 95% confidence intervals for change between baseline and final testing: all subjects.

JTHF: Jebsen–Taylor Hand Function; UNB: University of New Brunswick; AM-ULA: Activity Measure for Upper Limb Amputation; PSFS: PatientSpecific Functional Scale.

that the greatest gains in dexterity, skill, and activity performance are made in this early training period. However, perceived difficulty in patient-specific activity performance (PSFS) improved the most for RC users during the first 10 h and during the second 10 h for SC users, demonstrating the added value of more hours of training for patients with the most proximal level amputation. Our findings have implications for the choice of measures for clinical trials and practice. They can also inform clinicians about the amount of training that may be necessary to maximize specific outcomes with the DEKA Arm. For the DEKA Arm, it appears that dexterity is maximized very early in training, whereas the performance of self-selected functional activities continues to improve with more training visits. However, this finding is not surprising, and is, in fact, consistent with the emphasis used in our training protocols and those recommended by others that emphasize simple fine motor tasks at the initial phases of rehabilitation, progressing to more complex activities, and then self-selected activities as patients gain skill

proficiency. 27 Further research is needed to determine whether a similar phenomenon is observed when training users with other prostheses. Our study has several limitations. First, our sub-analyses of ES by level of the DEKA Arm involved small samples, resulting in wide CIs around ES estimates, which may have led us to erroneously conclude that some ESs were not significant. That said, none of the ES which had CIs containing zero were considered large, leading us to conclude that none of these measures were among the most responsive. Second, there may be limits to generalizability of findings of measure responsiveness for training with upper limb prosthetic devices other than the DEKA Arm. The DEKA Arm has some unique features, including multiple grip patterns and the need to toggle between grips to select the appropriate one, which may affect dexterity potential. Additional studies need to be performed to corroborate our ES findings during prosthetic training with other types of devices. Another limitation is that our subjects had a short introduction to the DEKA Arm controls using VRE and brief


9

Resnik and Borgia

Figure 2. Effect sizes and 95% confidence intervals for Box and Block and JTHF: Comparisons by prosthetic level, baseline–final testing, baseline to 10-h training, and 10 h to final testing. JTHF: Jebsen–Taylor Hand Function; RC: radial configuration; HC: humeral configuration; SC: shoulder configuration.


10


Figure 3. Effect sizes and 95% confidence intervals for JTHF, UNB, AM-ULA, and PSFS: Comparisons by prosthetic level, baseline– final testing, baseline to 10-h training, and 10 h to final testing. JTHF: Jebsen–Taylor Hand Function; UNB: University of New Brunswick; AM-ULA: Activity Measure for Upper Limb Amputation; PSFS: PatientSpecific Functional Scale; RC: radial configuration; HC: humeral configuration; SC: shoulder configuration.


11

Resnik and Borgia

Figure 4. Effect size and 95% confidence intervals for change between baseline and 10 h of training: all subjects.

JTHF: Jebsen–Taylor Hand Function; UNB: University of New Brunswick; AM-ULA: Activity Measure for Upper Limb Amputation; PSFS: PatientSpecific Functional Scale.

Figure 5. Effect size and 95% confidence intervals for change between 10 h of training and final testing: all subjects.

JTHF: Jebsen–Taylor Hand Function; UNB: University of New Brunswick; AM-ULA: Activity Measure for Upper Limb Amputation; PSFS: PatientSpecific Functional Scale; UEFS: Upper Extremity Functional Scale. Downloaded from poi.sagepub.com at Apollo Group - UOP on February 17, 2015

12


Figure 6. Effect size and 95% confidence intervals for change of the UEFS and UEFS Use scales between 10 h of training and final testing by level. UEFS: Upper Extremity Functional Scale.

“live” training prior to baseline testing with the DEKA Arm. This orientation was conducted in order to ensure safety of users before testing with a novel device. Therefore, our subjects were not absolute naive users of the DEKA Arm. Thus, the initial training effect may not have been captured and ESs estimated using baseline testing data and subsequent testing data are likely to be underestimated. Finally, we were unable to calculate the ES for the UEFS and UEFS Use scales from baseline to end of training, because we did not administer this measure at baseline testing. Therefore, our estimates of ES reflected only those changes from 10-h training to final testing, and therefore, we recognize that these are likely underestimates of the full training effect.

More study is needed to examine the responsiveness of the UEFS. These findings have implications for choice of measures for research and practice and inform clinicians about the amount of training necessary to maximize outcomes with the DEKA Arm. Author contribution Linda Resnik obtained funding, was the study Principal Investigator, designed the study, directed the analyses, and participated in drafting the article. Matthew Borgia participated in the data analysis, manuscript preparation and review.

Declaration of conflicting interests None declared.

Funding

Conclusion We found that the BB, JTHF light and heavy can tests, UNB skill and spontaneity tests, AM-ULA, and the PSFS were responsive to change during prosthetic training, and the PSFS, the AM-ULA, and the UNB prosthetic skill test were the most responsive to change. However, the responsiveness varied by prosthetic level. None of the JTHF tests (ES: −0.12 to 0.67), nor the UNB spontaneity test or the AM-ULA were responsive to change in transradial amputees. Dexterity measures appear to be most responsive during the early phase of prosthetic training, while measures of activity performance and skill were responsive throughout the entire period of prosthetic training.

This research was supported by VA RR&D, VA RR&D A6780 and VA RR&D A6780I DEKA’s support of the VA optimization studies was sponsored by the Defense Advanced Research Projects Agency and the U.S. Army Research Office.

References 1. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312(7023): 71–72. 2. Sorrel AL. Penalties add up. Tex Med 2013; 109(5): 35–39. 3. Wright V. Measurement of functional outcome with individuals who use upper extremity prosthetic devices: current and future directions. J Prosthet Orthot 2006; 18(2): 46–56.


13

Resnik and Borgia 4. Miller LA and Swanson S. Introduction to the academy’s state of the science conference on upper limb prosthetic outcome measures. J Prosthet Orthot 2009; 21(Suppl.): P1–P2. 5. Hill W, Stavdahl O, Hermansson L, et al. Functional outcomes in the WHO-ICF model: establishment of the Upper Limb Prosthetic Outcome Measures Group. J Prosthet Orthot 2009; 21(2): 115–119. 6. Hill WK, Hermansson P, Hubbard LN, et al. Upper Limb Prosthetic Outcome Measures (UPLOM): a working group and their findings. J Prosthet Orthot 2009; 21(4S): P69–P82. 7. Wright V. Prosthetic outcome measures for use with upper limb amputees: a systematic review of the peer-reviewed literature, 1970 to 2009. J Prosthet Orthot 2009; 21(4S): P3–P63. 8. Miller L and Swanson S. Summary and recommendations of the academy’s state of the science conference on upper limb prosthetic outcome measures. J Prosthet Orthot 2009; 21(4S): 83–89. 9. Heinemann AW, Bode RK and O’Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users’ Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int 2003; 27(3): 191–206. 10. Lindner HY, Natterlund BS and Hermansson LM. Upper limb prosthetic outcome measures: review and content comparison based on International Classification of Functioning, Disability and Health. Prosthet Orthot Int [Comparative Study Research Support, Non-U.S. Gov’t Review] 2010; 34(2): 109–128. 11. Resnik L, Baxter K, Borgia M, et al. Is the UNB test reliable and valid for use with adults with upper limb amputation? J Hand Ther [Research Support, U.S. Gov’t, Non-P.H.S.] 2013; 26(4): 353–359. 12. Resnik L and Borgia M. Reliability and validity of outcome measures for upper limb amputation. J Prosthet Orthot 2012; 24(4): 192–212. 13. Resnik L, Adams L, Borgia M, et al. Development and evaluation of the activities measure for upper limb amputees. Arch Phys Med Rehabil [Research Support, U.S. Gov’t, Non-P.H.S.] 2013; 94(3): 488–494.e4. 14. Desrosiers J, Bravo G, Hebert R, et al. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil 1994; 75(7): 751–755. 15. Mathiowetz V, Volland G, Kashman N, et al. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther 1985; 39(6): 386–391.

16. Platz T, Pinkowski C, van Wijck F, et al. Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study. Clin Rehabil 2005; 19(4): 404–411. 17. Rider B and Linden C. Comparison of standardized and nonstandardized administration of the Jebsen Hand Function Test. J Hand Ther 1988; 2: 121–123. 18. Burger H, Franchignoni F, Heinemann AW, et al. Validation of the orthotics and prosthetics user survey upper extremity functional status module in people with unilateral upper limb amputation. J Rehabil Med 2008; 40(5): 393–399. 19. Stratford P, Gill C, Westaway M, et al. Assessing disability and change on individual patients: a report of a patient specific measure. Physiother Can 1995; 47(4): 258–263. 20. Resnik L. Research update: VA study to optimize DEKA arm. J Rehabil Res Dev [Editorial] 2010; 47(3): ix–x. 21. Resnik L, Klinger SL and Etter K. The DEKA Arm: its features, functionality, and evolution during the Veterans Affairs Study to optimize the DEKA Arm. Prosthet Orthot Int. Epub ahead of print 22 October 2013. DOI: 10.1177/0309364613506913. 22. Resnik L, Etter K, Klinger SL, et al. Using virtual reality environment to facilitate training with advanced upper-limb prosthesis. J Rehabil Res Dev [Case Reports Research Support, U.S. Gov’t, Non-P.H.S.] 2011; 48(6): 707–718. 23. Resnik L, Lieberman Klinger S, Korp K, et al. Guest Editorial: Training Protocol for a Powered Shoulder Prosthesis. Journal of Rehabilitation Research and Development, in Press 2014. 24. Sanderson ER and Scott RN. UNB test of prosthetics function: a test for unilateral upper extremity amputees, ages 2–13. Fredericton, NB, Canada: University of New Brunswick, 1985. 25. Kazis LE, Anderson JJ and Meenan RF. Effect sizes for interpreting changes in health status. Med Care [Clinical Trial Research Support, U.S. Gov’t, P.H.S.] 1989; 27(Suppl. 3): S178–S189. 26. Resnik L, Borgia M, Latlief G, et al. Self-reported and performance based outcomes of using the DEKA Arm. J Rehabil Res Dev 2014; 51: 351–362. 27. Smurr LM, Gulick K, Yancosek K, et al. Managing the upper extremity amputee: a protocol for success. J Hand Ther 2008; 21(2): 160–175; quiz 176.


Prosthetic training: upper limb.

Upper Limb Outcome Measures Used in Stroke Rehabilitation Studies: A Systematic Literature Review.

The prosthetic treatment of upper limb deficiency.

Upper-Limb Prosthetic Myocontrol: Two Recommendations.

Psychometric evaluation of self-report outcome measures for prosthetic applications.

Comparative responsiveness of outcome measures for total knee arthroplasty.

A survey on robotic devices for upper limb rehabilitation.

Gait analysis in lower-limb amputation and prosthetic rehabilitation.

Surgical rehabilitation of the upper limb in tetraplegia.

Improving the outcome of prosthetic rehabilitation following orbital exenteration.

Quantifying prosthetic gait deviation using simple outcome measures.

Upper limb casting in stroke rehabilitation: rationale, options, and techniques.

Investigating measures of intensity during a structured upper limb exercise program in stroke rehabilitation: an exploratory study.

Robot assisted upper limb therapy combined with upper limb rehabilitation was at least as effective on a range of outcomes, and cost less to deliver, as an equal dose of upper limb rehabilitation alone for people with stroke.

Cyborg beast: a low-cost 3d-printed prosthetic hand for children with upper-limb differences.

High-density force myography: A possible alternative for upper-limb prosthetic control.

Usability testing of gaming and social media applications for stroke and cerebral palsy upper limb rehabilitation.

Using commercial video games for upper limb stroke rehabilitation: is this the way of the future?

Commercial gaming devices for stroke upper limb rehabilitation: a survey of current practice.

Use of Powered Prosthesis for Children with Upper Limb Deficiency at Hyogo Rehabilitation Center.

Application of wavelet packet transform on myoelectric pattern recognition for upper limb rehabilitation after stroke.

Changes in involved and uninvolved limb function during rehabilitation after anterior cruciate ligament reconstruction: implications for Limb Symmetry Index measures.

Detecting movement intent from scalp EEG in a novel upper limb robotic rehabilitation system for stroke.

How to design clinical rehabilitation trials for the upper paretic limb early post stroke?