R E V I E W
A R T I C L E
Efficacy of Orthoses for Children With Hypotonia: A Systematic Review Anna Weber, PT, DHS; Kathy Martin, PT, DHS Krannert School of Physical Therapy, the University of Indianapolis, Indianapolis, Indiana.
Purpose: The purpose of this systematic review of the literature was to determine the efficacy of orthoses for children with hypotonia and provide a concise summary of the state of the evidence in this area. Methods: Fifteen search terms were used to find articles addressing children with hypotonia, orthotic use, and physical therapy. Results: Ten articles met the inclusion criteria, but no level I evidence was found. Data were reported for body structure and activity components, but not participation outcomes. Current evidence suggests that foot orthoses and supramalleolar orthoses may benefit children with hypotonia; however, the evidence is low level. Conclusion: The evidence for efficacy of orthoses for children with hypotonia continues to have gaps with the following questions still unanswered: When is the optimal time to introduce orthoses? Are foot orthoses or supramalleolar orthoses more efficacious? Should orthoses be combined with physical therapy? (Pediatr Phys Ther 2014;26:38–47) Key words: child, child/preschool, hypotonia, orthoses, physical therapy, systematic review, treatment outcome INTRODUCTION Although there are varying and invalidated criteria for grading and diagnosing hypotonia, the hypotonic syndrome has been characterized in a survey of physical therapists and occupational therapists by decreased strength, decreased activity tolerance, delayed motor skill development, rounded shoulder posture, leaning on supports, hypermobile joints, and increased flexibility.1,2 Hypotonia may be associated with many different conditions, including those of neuromuscular, genetic, central nervous system, connective tissue, and/or metabolic origins.1 Down
0898-5669/110/261-0038 Pediatric Physical Therapy C 2014 Wolters Kluwer Health | Lippincott Williams & Copyright Wilkins and Section on Pediatrics of the American Physical Therapy Association
Correspondence: Kathy Martin, PT, DHS, Krannert School of Physical Therapy, the University of Indianapolis, 1400 Hannah Ave, Indianapolis, IN 46227 ([email protected]). At the time this article was written, Anna Weber was a Doctor of Physical Therapy student at Krannert School of Physical Therapy, the University of Indianapolis, Indianapolis, Indiana. The authors declare no conflict of interest. DOI: 10.1097/PEP.0000000000000011
38
Weber and Martin
syndrome (DS) is arguably the most common condition associated with hypotonia. The estimated incidence of DS worldwide is 1 in 1000 live births.3 Hypotonia and ligamentous laxity are often associated with DS; however, these characteristics are also known components of several other disorders, including Prader Willi and other developmental syndromes. Both hypotonia and ligamentous laxity may lead to lower extremity malalignment and orthopedic issues up the kinetic chain. Lauteslager et al4 have suggested that joint instability, contributing to nonoptimal musculoskeletal alignment, is influenced not only by joint laxity but also by decreased postural tone and insufficient cocontraction around a joint. Hypotonia and ligamentous laxity are seen in children with DS and other developmental syndromes. As a result, the foot and ankle complex of these children may be predisposed to a biomechanical disadvantage. This disadvantage may reflect inadequate stability and thus negatively affect postural control. Furthermore, bony alignment may be abnormal when compared with children who are developing typically. Abnormal pull of foot and ankle musculature on the maturing bony structure may lead to abnormal positioning and loading of the foot and ankle, possibly having a detrimental effect over time on the growth and remodeling of bone.5 The use of foot orthoses (FOs) and supramalleolar orthoses (SMOs) as an intervention to promote stability
Pediatric Physical Therapy
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
and functional mobility in children with hypotonia is the current standard of care. Mulvey et al6 have suggested that children with DS struggle to achieve sufficient joint stability in the lower extremities because of hypotonia and ligamentous laxity. They also theorized that the common delay in independent walking might be due to the child waiting until a higher level of stability and motor control develops. Children with hypotonia may also demonstrate difficulty exploring their environment secondary to poor postural control and balance. The use of orthoses may help to provide the additional stability necessary to allow a child to get on her feet and more effectively explore the environment and thus enhance overall development. The use of FOs and SMOs has become the standard of care for many children with hypotonia, yet many questions remain about the efficacy of this intervention for this population. Thus, the purpose of this study was to systematically review the literature on the efficacy of orthotic use for children with hypotonia and to provide a concise summary of the state of the evidence in this area.
METHODS We independently completed a literature search using 5 databases and search engines between January 2012 and February 2012 (Table 1). Fifteen individual search terms were used alone and in combination to capture a broad range of articles. The search focused on articles addressing children with hypotonia or DS, orthotic use, and physical therapy (PT). The search was updated in May 2012 and again in September 2012 using the same search terms. Articles were initially included by title relevance, then screened by abstract, and finally full-text analysis (Figure 1). Each author independently evaluated each fulltext article to determine final inclusion. Inclusion criteria for articles included participants who were children from birth to 21 years of age with hypotonia and/or DS. Impairments such as flexible flat feet and hyperpronation were excluded unless explicit acknowlTABLE 1
Idenfied through database searches (21, 942)
Records aer duplicate and nonrelevant arcles removed (26)
•18 arcles excluded (reasons: review or opinion, not specific to FO/SMO, no menon of hypotonia/low muscle tone, not peer-reviewed)
Studies included in review
Arcles idenfied through addional searches May 2012, September 2012
(10)
(2) Studies scored and included in analysis (10)
Fig. 1. Article selection process.
edgement of hypotonia or low muscle tone was also included. The intervention of interest was the use of orthoses. Simultaneous intervention with PT was neither an inclusion nor an exclusion criterion. Articles were excluded if the article was not peer-reviewed, was solely an abstract, did not include children with hypotonia as participants, did not examine the efficacy of orthoses as the intervention, or was not accessible in English. Once the final collection of articles was chosen, the articles were then graded according to the level of evidence on the basis of the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM)7 guidelines for randomized controlled trials and single and group design studies (Table 2). The AACPDM rating system has been shown to have acceptable interrater reliability.15 Case studies were graded using a scale we developed by adapting Atkins and Sampson16 single case study guidelines (Table 3). Each author initially performed an independent grading of articles. If we did not agree on a grade for an article, we discussed the grading to see whether a consensus could be reached. If a consensus was not reached, a third independent reader was used. Articles were included regardless of the AACPDM score or the level of evidence.
Databases and Search Terms Databases CINAHL Plus with full text PEDro Medline SPORTDiscus PubMed
Pediatric Physical Therapy
Search Terms Foot orthoses Hyperpronation of the foot Down syndrome Pediatric Pediatric physical therapy Child development disorders, pervasive Developmental disability Child development disorders, therapy Muscle hypotonia Muscle hypotonia/rehab Muscle hypotonia/therapy Children Foot deformities, congenital Orthotic devices Developmental delay
RESULTS Included Articles The search strategy resulted in a total of 10 articles that met the criteria for this review. No level I evidence was found that met inclusion criteria during this search. Three level II articles, 5 level IV articles, and 2 level V articles were identified and included in this analysis (Table 4). Of the 10 articles reviewed, 5 articles concerned FOs only,12-14,17,18 4 addressed SMOs only,5,8,9,11 and 1 compared FOs and SMOs.10 In all studies, participants ranged in age from 18 months to 10 years. Data on PT or other structured physical activity were presented in 5 studies.8,9,12,17,18 Five studies5,10,11,13,14 did not include any additional activity beyond what the child was already doing Efficacy of Orthoses for Children With Hypotonia 39
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
TABLE 2 Group Studies Gradinga
Looper and Ulrich8 Looper and Ulrich9 Looper et al10 Martin11 Ross and Shore12 Pitetti and Wondra13 Selby-Silverstein et al14 Tamminga et al5
1
2
3
4
5
6
7
Total Score
Yes Yes Yes Yes Yes Yes Yes Yes
Yes Yes Yes Yes No Yes Yes No
Yes Yes Yes Yes No Yes Yes Yes
No No No No No No Yes No
Yes No No No No No No No
No No Yes Yes Yes No Yes Yes
Yes Yes Yes Yes Yes Yes Yes Yes
5 4 5 5 3 4 6 4
a Conduct questions: 1. Were inclusion and exclusion criteria of the study population well described and followed? 2. Was the intervention well described and was there adherence to the intervention assignment? (For 2-group designs, was the control exposure also well described?) Both parts of the question need to be met to score “yes.” 3. Were the measures used clearly described, valid, and reliable for measuring the outcomes of interest? 4. Was the outcome assessor unaware of the intervention status of the participants (ie, were the assessors masked)? 5. Did the authors conduct and report appropriate statistical evaluation including power calculations? Both parts of the question need to be met to score “yes.” 6. Were dropouts/loss to follow-up reported and less than 20%? For 2-group designs, was dropout balanced? 7. Considering the potential within the study design, were appropriate methods for controlling confounding variables and limiting potential biases used?
TABLE 3 Case Studies Gradinga
Buccieri17 George and Elchert18
1
2
3
4
5
6
7
8
9
10
Total Score
Yes Yes
Yes Yes
Yes No
Yes Yes
Yes Yes
No Yes
No No
Yes Yes
Yes No
Yes Yes
8 7
a Conduct questions: 1. Was the purpose/aim of the case study clearly stated? 2. Was the participant clearly described, including all relevant information regarding clinical presentation? 3. Were all interventions described in enough detail to allow replication? 4. Were the data collection procedures described in appropriate detail and were they done at appropriate times (at a minimum, pre and postintervention)? 5. Were all variables operationally defined? 6. Were valid and reliable measures of the dependent variable used? 7. Did the authors establish and report their own reliability with these measures? 8. Did the data support the authors’ conclusions? 9. Did the authors include a discussion of the clinical relevance of the data? 10. Did the authors appropriately acknowledge limitations of the study?
before the study. The International Classification of Functioning, Disability and Health (ICF)19 body structure and function component12,14,17 was assessed in 3 studies, and outcomes for the ICF activity component were included in all 10 studies. The authors of 1 study attempted to correlate body structure measures (barefoot) to an activity component outcome when subjects used orthoses.10
lated. These calculations show that overall the questions were consistent within each rater, but when a disagreement did occur, the kappa value was very low because of the small data pool. Furthermore, the statistics showed that the AACPDM grading rubric used had good internal consistency and was valid (Table 5). Study Characteristics
Interrater Reliability We examined titles and abstracts for exclusion with an agreement kappa of 100% (κ = 1). When grading group studies, we had good overall agreement (Cronbach α = 0.96; Pearson r = 0.9264; 95% confidence interval = 0.6390.986). The 2 case studies were not included in the Cronbach α and Pearson calculations because of limited data, nor were they included with the group studies calculations because the grading criteria for these reports were different. Within the group and case studies, the kappa values of each individual question of the grading rubric were calcu40
Weber and Martin
The 10 included studies are summarized in Table 4. They are reported here according to the ICF framework. Foot Orthoses and ICF Body Structure and Function Component An FO intervention was used in the 3 studies with an ICF body structure and function outcome measure.12,14,17 The body structure outcome measures included the arch index12 and visual analysis of static standing alignment.14,17 The studies had a total of 52 participants (30 experimental and 22 control) with DS, developmental Pediatric Physical Therapy
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
Pediatric Physical Therapy
Efficacy of Orthoses for Children With Hypotonia 41
Looper et al10
Looper and Ulrich9
Looper and Ulrich8
IV
II
DS, walking at least 6 mos (with or without AD)
DS, could pull to stand
Case report/ V Hydrocephalus Absence of corpus callosum DD, LE hypotonia II DS, could pull to stand
George and Elchert18
Participants
Case report/V Low tone DD
AACPDM Level of Evidence
Buccieri17
Authors
6
10 exp 7 control
10 exp, 7 control
1
1
Total N
Custom-modified stabilizing foot splint FO Aquaplast SureStep SMOs and treadmill training
Alipast custom-made FO, with Nickelplast posting with PT × 5 mos
Intervention
4-7 yrs
Leap frog and cricket, off-shelf and unmodified
Exp: 21.4 mos SureStep SMOs and treadmill training ±4 Control: 19.25 mos ± 6.3
Exp: 21.4 mos ±4 Control: 19.25 mos ± 6.3
19 mos
25 mos
Ages
TABLE 4 Article Summaries
PDMS Foot alignment in standing
Dependent Measures
Results
PDMS yielded age-appropriate gross motor score; age equivalency improved 12 mos in a 5-mo period; persistent low muscle tone Overall improvement on all NA Five items from items with shoes and FO; PDMS-2 and time to greatest improvement in 4 complete these skills steps forward Treadmill training GMFM, time in study, SMOs showed moderate in shoes only age at walking onset treatment effect on time of onset of independent walking; control group had larger improvements on crawling and kneeling dimension and better overall GMFM scores at 1 mo after onset of walking Treadmill training Video coding for time No significant group differences, but a trend toward control in shoes only spent in upright group leaning on trunk more posture, leaning, whereas exp. group leaned nonleaning, and 0, 1, less but propped more or 2 hand support Barefoot GAITRite data; Significant decrease in cadence anthropomorphic and wearing SMOs compared with biomechanical data barefoot; greater cycle time wearing SMOs than with FOs and barefoot; hypermobility was strongly correlated with several gait parameters; based on gait analysis, FOs were recommended for 3 children, SMOs for 2 children and no orthoses for 1 child (continues) NA
Control Condition
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
42
Weber and Martin
Pediatric Physical Therapy
IV
IV
II
IV
IV
Martin11
Pitetti and Wondra13
Ross and Shore12
Selby-Silverstein et al14
Tamminga et al5 DS; sitting independently but not yet walking
DS and excessive pronation
DD, flexible flat feet, ambulating independently
DD with z-score
A R T I C L E
Efficacy of Orthoses for Children With Hypotonia: A Systematic Review Anna Weber, PT, DHS; Kathy Martin, PT, DHS Krannert School of Physical Therapy, the University of Indianapolis, Indianapolis, Indiana.
Purpose: The purpose of this systematic review of the literature was to determine the efficacy of orthoses for children with hypotonia and provide a concise summary of the state of the evidence in this area. Methods: Fifteen search terms were used to find articles addressing children with hypotonia, orthotic use, and physical therapy. Results: Ten articles met the inclusion criteria, but no level I evidence was found. Data were reported for body structure and activity components, but not participation outcomes. Current evidence suggests that foot orthoses and supramalleolar orthoses may benefit children with hypotonia; however, the evidence is low level. Conclusion: The evidence for efficacy of orthoses for children with hypotonia continues to have gaps with the following questions still unanswered: When is the optimal time to introduce orthoses? Are foot orthoses or supramalleolar orthoses more efficacious? Should orthoses be combined with physical therapy? (Pediatr Phys Ther 2014;26:38–47) Key words: child, child/preschool, hypotonia, orthoses, physical therapy, systematic review, treatment outcome INTRODUCTION Although there are varying and invalidated criteria for grading and diagnosing hypotonia, the hypotonic syndrome has been characterized in a survey of physical therapists and occupational therapists by decreased strength, decreased activity tolerance, delayed motor skill development, rounded shoulder posture, leaning on supports, hypermobile joints, and increased flexibility.1,2 Hypotonia may be associated with many different conditions, including those of neuromuscular, genetic, central nervous system, connective tissue, and/or metabolic origins.1 Down
0898-5669/110/261-0038 Pediatric Physical Therapy C 2014 Wolters Kluwer Health | Lippincott Williams & Copyright Wilkins and Section on Pediatrics of the American Physical Therapy Association
Correspondence: Kathy Martin, PT, DHS, Krannert School of Physical Therapy, the University of Indianapolis, 1400 Hannah Ave, Indianapolis, IN 46227 ([email protected]). At the time this article was written, Anna Weber was a Doctor of Physical Therapy student at Krannert School of Physical Therapy, the University of Indianapolis, Indianapolis, Indiana. The authors declare no conflict of interest. DOI: 10.1097/PEP.0000000000000011
38
Weber and Martin
syndrome (DS) is arguably the most common condition associated with hypotonia. The estimated incidence of DS worldwide is 1 in 1000 live births.3 Hypotonia and ligamentous laxity are often associated with DS; however, these characteristics are also known components of several other disorders, including Prader Willi and other developmental syndromes. Both hypotonia and ligamentous laxity may lead to lower extremity malalignment and orthopedic issues up the kinetic chain. Lauteslager et al4 have suggested that joint instability, contributing to nonoptimal musculoskeletal alignment, is influenced not only by joint laxity but also by decreased postural tone and insufficient cocontraction around a joint. Hypotonia and ligamentous laxity are seen in children with DS and other developmental syndromes. As a result, the foot and ankle complex of these children may be predisposed to a biomechanical disadvantage. This disadvantage may reflect inadequate stability and thus negatively affect postural control. Furthermore, bony alignment may be abnormal when compared with children who are developing typically. Abnormal pull of foot and ankle musculature on the maturing bony structure may lead to abnormal positioning and loading of the foot and ankle, possibly having a detrimental effect over time on the growth and remodeling of bone.5 The use of foot orthoses (FOs) and supramalleolar orthoses (SMOs) as an intervention to promote stability
Pediatric Physical Therapy
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
and functional mobility in children with hypotonia is the current standard of care. Mulvey et al6 have suggested that children with DS struggle to achieve sufficient joint stability in the lower extremities because of hypotonia and ligamentous laxity. They also theorized that the common delay in independent walking might be due to the child waiting until a higher level of stability and motor control develops. Children with hypotonia may also demonstrate difficulty exploring their environment secondary to poor postural control and balance. The use of orthoses may help to provide the additional stability necessary to allow a child to get on her feet and more effectively explore the environment and thus enhance overall development. The use of FOs and SMOs has become the standard of care for many children with hypotonia, yet many questions remain about the efficacy of this intervention for this population. Thus, the purpose of this study was to systematically review the literature on the efficacy of orthotic use for children with hypotonia and to provide a concise summary of the state of the evidence in this area.
METHODS We independently completed a literature search using 5 databases and search engines between January 2012 and February 2012 (Table 1). Fifteen individual search terms were used alone and in combination to capture a broad range of articles. The search focused on articles addressing children with hypotonia or DS, orthotic use, and physical therapy (PT). The search was updated in May 2012 and again in September 2012 using the same search terms. Articles were initially included by title relevance, then screened by abstract, and finally full-text analysis (Figure 1). Each author independently evaluated each fulltext article to determine final inclusion. Inclusion criteria for articles included participants who were children from birth to 21 years of age with hypotonia and/or DS. Impairments such as flexible flat feet and hyperpronation were excluded unless explicit acknowlTABLE 1
Idenfied through database searches (21, 942)
Records aer duplicate and nonrelevant arcles removed (26)
•18 arcles excluded (reasons: review or opinion, not specific to FO/SMO, no menon of hypotonia/low muscle tone, not peer-reviewed)
Studies included in review
Arcles idenfied through addional searches May 2012, September 2012
(10)
(2) Studies scored and included in analysis (10)
Fig. 1. Article selection process.
edgement of hypotonia or low muscle tone was also included. The intervention of interest was the use of orthoses. Simultaneous intervention with PT was neither an inclusion nor an exclusion criterion. Articles were excluded if the article was not peer-reviewed, was solely an abstract, did not include children with hypotonia as participants, did not examine the efficacy of orthoses as the intervention, or was not accessible in English. Once the final collection of articles was chosen, the articles were then graded according to the level of evidence on the basis of the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM)7 guidelines for randomized controlled trials and single and group design studies (Table 2). The AACPDM rating system has been shown to have acceptable interrater reliability.15 Case studies were graded using a scale we developed by adapting Atkins and Sampson16 single case study guidelines (Table 3). Each author initially performed an independent grading of articles. If we did not agree on a grade for an article, we discussed the grading to see whether a consensus could be reached. If a consensus was not reached, a third independent reader was used. Articles were included regardless of the AACPDM score or the level of evidence.
Databases and Search Terms Databases CINAHL Plus with full text PEDro Medline SPORTDiscus PubMed
Pediatric Physical Therapy
Search Terms Foot orthoses Hyperpronation of the foot Down syndrome Pediatric Pediatric physical therapy Child development disorders, pervasive Developmental disability Child development disorders, therapy Muscle hypotonia Muscle hypotonia/rehab Muscle hypotonia/therapy Children Foot deformities, congenital Orthotic devices Developmental delay
RESULTS Included Articles The search strategy resulted in a total of 10 articles that met the criteria for this review. No level I evidence was found that met inclusion criteria during this search. Three level II articles, 5 level IV articles, and 2 level V articles were identified and included in this analysis (Table 4). Of the 10 articles reviewed, 5 articles concerned FOs only,12-14,17,18 4 addressed SMOs only,5,8,9,11 and 1 compared FOs and SMOs.10 In all studies, participants ranged in age from 18 months to 10 years. Data on PT or other structured physical activity were presented in 5 studies.8,9,12,17,18 Five studies5,10,11,13,14 did not include any additional activity beyond what the child was already doing Efficacy of Orthoses for Children With Hypotonia 39
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
TABLE 2 Group Studies Gradinga
Looper and Ulrich8 Looper and Ulrich9 Looper et al10 Martin11 Ross and Shore12 Pitetti and Wondra13 Selby-Silverstein et al14 Tamminga et al5
1
2
3
4
5
6
7
Total Score
Yes Yes Yes Yes Yes Yes Yes Yes
Yes Yes Yes Yes No Yes Yes No
Yes Yes Yes Yes No Yes Yes Yes
No No No No No No Yes No
Yes No No No No No No No
No No Yes Yes Yes No Yes Yes
Yes Yes Yes Yes Yes Yes Yes Yes
5 4 5 5 3 4 6 4
a Conduct questions: 1. Were inclusion and exclusion criteria of the study population well described and followed? 2. Was the intervention well described and was there adherence to the intervention assignment? (For 2-group designs, was the control exposure also well described?) Both parts of the question need to be met to score “yes.” 3. Were the measures used clearly described, valid, and reliable for measuring the outcomes of interest? 4. Was the outcome assessor unaware of the intervention status of the participants (ie, were the assessors masked)? 5. Did the authors conduct and report appropriate statistical evaluation including power calculations? Both parts of the question need to be met to score “yes.” 6. Were dropouts/loss to follow-up reported and less than 20%? For 2-group designs, was dropout balanced? 7. Considering the potential within the study design, were appropriate methods for controlling confounding variables and limiting potential biases used?
TABLE 3 Case Studies Gradinga
Buccieri17 George and Elchert18
1
2
3
4
5
6
7
8
9
10
Total Score
Yes Yes
Yes Yes
Yes No
Yes Yes
Yes Yes
No Yes
No No
Yes Yes
Yes No
Yes Yes
8 7
a Conduct questions: 1. Was the purpose/aim of the case study clearly stated? 2. Was the participant clearly described, including all relevant information regarding clinical presentation? 3. Were all interventions described in enough detail to allow replication? 4. Were the data collection procedures described in appropriate detail and were they done at appropriate times (at a minimum, pre and postintervention)? 5. Were all variables operationally defined? 6. Were valid and reliable measures of the dependent variable used? 7. Did the authors establish and report their own reliability with these measures? 8. Did the data support the authors’ conclusions? 9. Did the authors include a discussion of the clinical relevance of the data? 10. Did the authors appropriately acknowledge limitations of the study?
before the study. The International Classification of Functioning, Disability and Health (ICF)19 body structure and function component12,14,17 was assessed in 3 studies, and outcomes for the ICF activity component were included in all 10 studies. The authors of 1 study attempted to correlate body structure measures (barefoot) to an activity component outcome when subjects used orthoses.10
lated. These calculations show that overall the questions were consistent within each rater, but when a disagreement did occur, the kappa value was very low because of the small data pool. Furthermore, the statistics showed that the AACPDM grading rubric used had good internal consistency and was valid (Table 5). Study Characteristics
Interrater Reliability We examined titles and abstracts for exclusion with an agreement kappa of 100% (κ = 1). When grading group studies, we had good overall agreement (Cronbach α = 0.96; Pearson r = 0.9264; 95% confidence interval = 0.6390.986). The 2 case studies were not included in the Cronbach α and Pearson calculations because of limited data, nor were they included with the group studies calculations because the grading criteria for these reports were different. Within the group and case studies, the kappa values of each individual question of the grading rubric were calcu40
Weber and Martin
The 10 included studies are summarized in Table 4. They are reported here according to the ICF framework. Foot Orthoses and ICF Body Structure and Function Component An FO intervention was used in the 3 studies with an ICF body structure and function outcome measure.12,14,17 The body structure outcome measures included the arch index12 and visual analysis of static standing alignment.14,17 The studies had a total of 52 participants (30 experimental and 22 control) with DS, developmental Pediatric Physical Therapy
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
Pediatric Physical Therapy
Efficacy of Orthoses for Children With Hypotonia 41
Looper et al10
Looper and Ulrich9
Looper and Ulrich8
IV
II
DS, walking at least 6 mos (with or without AD)
DS, could pull to stand
Case report/ V Hydrocephalus Absence of corpus callosum DD, LE hypotonia II DS, could pull to stand
George and Elchert18
Participants
Case report/V Low tone DD
AACPDM Level of Evidence
Buccieri17
Authors
6
10 exp 7 control
10 exp, 7 control
1
1
Total N
Custom-modified stabilizing foot splint FO Aquaplast SureStep SMOs and treadmill training
Alipast custom-made FO, with Nickelplast posting with PT × 5 mos
Intervention
4-7 yrs
Leap frog and cricket, off-shelf and unmodified
Exp: 21.4 mos SureStep SMOs and treadmill training ±4 Control: 19.25 mos ± 6.3
Exp: 21.4 mos ±4 Control: 19.25 mos ± 6.3
19 mos
25 mos
Ages
TABLE 4 Article Summaries
PDMS Foot alignment in standing
Dependent Measures
Results
PDMS yielded age-appropriate gross motor score; age equivalency improved 12 mos in a 5-mo period; persistent low muscle tone Overall improvement on all NA Five items from items with shoes and FO; PDMS-2 and time to greatest improvement in 4 complete these skills steps forward Treadmill training GMFM, time in study, SMOs showed moderate in shoes only age at walking onset treatment effect on time of onset of independent walking; control group had larger improvements on crawling and kneeling dimension and better overall GMFM scores at 1 mo after onset of walking Treadmill training Video coding for time No significant group differences, but a trend toward control in shoes only spent in upright group leaning on trunk more posture, leaning, whereas exp. group leaned nonleaning, and 0, 1, less but propped more or 2 hand support Barefoot GAITRite data; Significant decrease in cadence anthropomorphic and wearing SMOs compared with biomechanical data barefoot; greater cycle time wearing SMOs than with FOs and barefoot; hypermobility was strongly correlated with several gait parameters; based on gait analysis, FOs were recommended for 3 children, SMOs for 2 children and no orthoses for 1 child (continues) NA
Control Condition
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
42
Weber and Martin
Pediatric Physical Therapy
IV
IV
II
IV
IV
Martin11
Pitetti and Wondra13
Ross and Shore12
Selby-Silverstein et al14
Tamminga et al5 DS; sitting independently but not yet walking
DS and excessive pronation
DD, flexible flat feet, ambulating independently
DD with z-score
