INTRODUCTION AND PURPOSE
Approximately 7% to 16% of North American children younger than 19 years have a disability.1,2 Many of these children present with a motor impairment that occurs with diagnoses such as cerebral palsy (CP), Down syndrome (DS), and spinal cord injury (SCI). Because no cure exists for these conditions, one of the primary aims of intervention is to improve functional motor skills once the cause of functional deficit and severity of dysfunction have been determined.3 Walking is a fundamental motor performance task and, in the case of families of children with CP, is the motor skill most frequently requested as the goal of intervention.4 Developing walking skills can have a significant effect on function in many areas of life for all children. Children who are able to walk are more successful in social roles and activities of daily living than children who use a wheelchair.5 It is reasonable to predict that for selected children with motor impairments, for example, children with CP with favorable motor prognoses based upon Gross Motor Function Classification System (GMFCS) motor development curves,6 improving the ability to walk may lead to reduced restrictions and enhanced participation in life activities.
Recently, a number of studies of the effectiveness of treadmill training (TT) with and without partial body-weight support (PBWS) in children with motor impairments have been published, reporting varying results. PBWSTT involves the use of a body-weight support (BWS) harness during the treatment and is congruent with contemporary models of motor control and motor learning that recommend a task-specific approach with emphasis on repetition and practice.4 More specifically, this partial unweighting allows the child to practice walking at a faster, more typical pace without the exertion associated with overground walking.7 The support harness also allows therapists to use their hands to manually assist the child in walking. However, research results published thus far on the effectiveness of PBWSTT and other types of TT have been variable, making it difficult to interpret which type of TT provides superior results and for which motor impairments it is effective.
In an attempt to synthesize the available evidence, a number of systematic reviews on this topic have recently been published. Systematic reviews use predetermined methods that reduce bias and errors in summarizing the results of original studies.8 Thorough review of the quality and content of published systematic reviews is, however, still needed to ensure that these have been conducted in a manner that minimizes errors and ensures that findings are appropriately interpreted and applied.9,10 With this in mind, the purpose of this review was to synthesize the current evidence from systematic reviews on the effectiveness of TT with/without PBWS in children with motor impairments.
METHOD USED TO CONDUCT THE REVIEW
Data Sources and Searches
We conducted a comprehensive systematic review of the literature to identify relevant articles. A medical librarian conducted searches of the scientific literature in the following 10 databases to May 27, 2010: AMED, CDSR, CINAHL, DARE, EMBASE, ERIC, MEDLINE, PEDro, PsychINFO, and SPORTDiscus. A sample search strategy used for MEDLINE can be found in Appendix 1. All other search strategies are available from the corresponding author.
We only considered systematic reviews for inclusion in this overview. A systematic review was defined as a review in which authors outlined a search strategy with criteria for study inclusion and synthesized the data from the included studies. To be included, each systematic review also had to involve (1) either PBWS and/or TT as an intervention, (2) children from birth to 21 years of age, and (3) a diagnosis consistent with having a motor impairment. The overview was limited to systematic reviews published in English in peer-reviewed journals. Reviews published only in abstract or dissertation form were excluded.
We independently reviewed studies identified in the literature search at all stages of study selection. Studies were initially screened on the basis of title, then abstract, and then full-text reviews to confirm inclusion in the overview. At the title review stage, any title selected by either reviewer was included in the abstract review. For the abstract and full-text reviews, we used checklists with inclusion criteria to record decisions for each reviewer; disagreements were resolved by consensus.
Data Extraction and Quality Assessment
We used the AMSTAR scale to assess the methodological quality of the included systematic reviews. The AMSTAR is a reliable and valid 11-item checklist for evaluating systematic reviews10–12 and is described in Table 1. We scored independently each systematic review and resolved disagreement by consensus. The only disagreement was in rating 1 article13 in terms of the comprehensiveness of the search and assessment of study quality.
We each extracted descriptive and outcome data from the included systematic reviews and resolved any disagreements by consensus. These data included number of studies reviewed in each systematic review, number of studies for each type of TT intervention, number of children by diagnosis, age categories of children (Table 2), levels of evidence reported for each study included in each systematic review (Table 3), and levels of evidence and outcomes by intervention for CP (Table 4), DS (Table 5), SCI (Table 6), and other and mixed diagnoses (Table 7). We also independently extracted the number of children with CP in each category of GMFCS level, motor type, and body distribution (Appendix 2), number of children by level of SCI and ASIA class (Appendix 3), number of children participating in each type of intervention (Appendix 4), range of speed, BWS, and duration parameters for intervention (Appendix 5), and frequency and duration of intervention sessions (Appendix 6).
We created descriptive summaries and evidence tables for each systematic review to synthesize which studies and interventions were included in each systematic review (Tables 2 and 3). We then created outcomes tables for results listed in each review (Tables 4 to 7) and classified them according to Sackett's levels of evidence14 (Appendix 7) and the International Classification of Functioning, Disability and Health's (ICF's) components of Body Structures and Functions (BS and F) versus Activity and Participation (A and P).15 For cases in which conflicting outcomes were described in 2 or more reviews, we independently reviewed study outcomes and entered the data in the most appropriate evidence column, as determined by consensus.
Five systematic reviews met the inclusion criteria for this overview.13,16–19Figure 1 demonstrates the search process and results of each review step. Of the 32 studies that were included for full-text review, 27 were excluded (reasons for exclusion are listed in Figure 1). Cohen's kappa was used to examine interrater inclusion/exclusion agreement with substantial to perfect levels of agreement20 (κ = 0.78 at abstract review stage; κ = 1.0 at full-text review stage).
The 5 systematic reviews were located in 7 of the 10 databases searched: CINAHL, EMBASE, ERIC, MEDLINE, PEDro, PsychINFO, and SPORTDiscus. Four of the reviews16–19 were located in more than 1 database and 1 review13 was available only through CINAHL.
Methodological Quality of the Reviews
Table 1 summarizes the results of the quality analysis conducted with the AMSTAR. Other authors have described scores of 8 to 11 as high quality, 4 to 7 as moderate quality, and 0 to 3 as low quality.21,22 Using this same convention, 2 of the included systematic reviews were of high quality,16,19 2 were of medium quality,17,18 and 1 was of low quality.13
Description of the Reviews
The systematic reviews were published between 2006 and 2009, with 416–19 of 5 being published in 2009. Table 2 provides an overview of the reviews including the number of studies included in each review, the total number of children with specific diagnoses, their age range, and the type of TT intervention received. The highest number of participants was involved in PBWSTT, followed by TT only, robotic-assisted PBWSTT, and mixed TT interventions. No studies examined the use of PBWS for overground walking. Children with CP were most highly represented, followed by children with DS, mixed or other central nervous system (CNS) impairments, and SCI. Most studies included children 3 years or older (Table 2), with the exception of 5 studies that included younger children with CP23–27 and all studies of children with DS (ages 4-13 months).28–33
In addition to the broad diagnostic categories listed in Table 2, Appendixes 2 and 3 summarize in greater detail the diagnostic characteristics of children with CP and SCI involved in the studies. Children with CP were most frequently classified as a GMFCS III or IV; children were most often diagnosed as having a spastic motor-type presentation with body distribution encompassing all 3 frequently occurring patterns of diplegia, quadriplegia, and hemiplegia. For children with SCI, level of injury was either at the cervical or thoracic level and was classified as ASIA A, C, or D.
Appendix 4 summarizes in detail the number of children with specific diagnoses who participated in each type of intervention for each systematic review. Children with CP, “other” diagnoses, and “mixed” diagnoses were involved in all types of TT, whereas children with DS participated exclusively in TT only. Children with SCI participated in a variety of different types of TT including PBWSTT, robotic-assist PBWSTT, and mixed types of TT.
Levels of evidence were assigned to studies in all but 1 review19 and were all based on Sackett's levels of evidence14; only 1 systematic review used the most recent version of the Sackett classification of evidence.18Table 3 provides a summary of the levels of evidence assigned to the studies included in each review with results classified by diagnosis and intervention. As some studies were rated differently across the systematic reviews, we independently determined the level of evidence for each study, represented by the consensus score in Table 3. We reached consensus for level of evidence ratings without any disagreements.
Lastly, as intervention characteristics in the literature were quite variable, Appendix 5 illustrates the range of speed, body-weight support, and session duration in all studies included in the reviews, whereas Appendix 6 summarizes the number of sessions per week and total number of weeks used in the protocols of each study.
Effectiveness of BWS and/or Treadmill Training
Tables 4 through 7 summarize the levels of evidence (as per consensus rating) supporting outcomes as described in the reviews. An important finding is that no negative outcomes were reported in any reviews with the exception of some children complaining of exhaustion with intervention4; however, many individual studies did not report the presence or absence of negative outcomes in their research.16
We found many inconsistencies in how the outcome data were interpreted and reported across the systematic reviews. For example, 1 systematic review16 reported positive but nonsignificant improvement in percentage of double limb support in the study by Cherng et al 34; another systematic review18 reported this finding as statistically significant and 2 other reviews did not report on this outcome at all.17,19 We also noted differences in how systematic reviews reported similar findings. For example, the study by Begnoche et al24 was reported in 1 systematic review as having nonsignificant changes in Gross Motor Function Measure (GMFM) total scores,16 and 2 other systematic reviews not only reported the same finding but also indicated that 4 of 5 children had total score improvements.17,18 The small sample size of the original study may have precluded finding statistically significant differences between groups, but the positive findings may be clinically relevant. As many studies had sample sizes that were too small to allow for statistical analysis or to detect significant differences, we opted to report outcomes as positive if there was a trend toward better outcomes or if more than half of the sample achieved positive gains. Results that were statistically significant are represented in bold. Results that were inconclusive or showed no change were combined in 1 column.
This grouping contained the largest number of studies (20), of which the majority pertained to PBWSTT (15),4,23,24,26,27,34–43 followed by TT only (4),25,44–46 and 1 study on robotic PBWSTT.47 Levels of evidence ranged from II to V, with 18 of 20 studies being rated as levels IV or V (see Table 4). Many studies reported positive outcomes when using PBWSTT with children with CP in both BS and F and A and P outcomes. In addition to a number of anecdotally positive outcomes, statistically significant results were noted in 8 outcome measures, including temporal-spatial characteristics of gait and GMFM scores. When evaluating TT on its own, a number of positive outcomes were found in the BS and F component of the ICF, with statistically significant findings in stride/step length, sit-to-stand, lateral step test, and the motor assessment scale. In addition, statistically significant findings at level II were reported for GMFM dimensions D and E and at level IV for the 10-m walk test. Finally, results from 1 level V study using robotic-assist PBWSTT showed mixed results in the BS and F and A and P dimensions.
This grouping consisted of 6 studies28–33 but stemmed from only 2 unique samples.30,31 All studies utilized TT at levels of evidence II and IV, with statistically significant improvements in a variety of outcomes in the BS and F dimension of the ICF, including gait temporal-spatial characteristics, obstacle negotiation strategies, and onset of walking. No outcomes in the A and P dimension were reported (see Table 5).
Spinal Cord Injury
Six studies were focused on the effect of PBWSTT48,49 or mixed TT50–53 in children with SCI. All studies were rated as level IV or V (see Table 6). Two level IV studies stemming from 1 sample found mixed results in the BS and F component of the ICF when examining the use of PBWSTT. Four studies using a combination of TT methods showed mixed outcomes at the BS and F level but suggested positive outcomes in the A and P component, that is, reaching and motor function.
Other Central Nervous System Motor Impairments and Mixed Diagnoses
Three studies at level IV or V examined the effect of PBWSTT, robotic PBWSTT, or mixed TT in individuals with other CNS motor impairments (see Table 7). A case study54 showed that the use of PBWSTT in 1 adolescent with an acquired brain injury (ABI) had a positive influence on walking ability. Lotan et al55 examined the effectiveness of TT in children with Rett syndrome and identified statistically significant changes in resting heart rate and motor function, in addition to a positive, albeit nonsignificant, improvement in heart rate during activity. Lastly, Cernak et al56 evaluated the use of mixed methods of TT in 1 adolescent with cerebellar ataxia and found an improvement in the number of unassisted treadmill steps taken during the intervention phases.
Three level III or IV studies evaluated the effects of PBWSTT,57 robotic PBWSTT,58 or mixed TT59 in children of mixed diagnoses (see Table 7). Stuberg et al57 examined the use of PBWSTT in a group of children with CP, myotonia, or Angelman syndrome and demonstrated mixed results in the BS and F categories but positive changes in 2 A and P outcomes. The only statistically significant outcome was found in walking velocity. Meyer-Heim et al58 evaluated the use of robotic-assist PBWSTT in children with conditions such as Guillain-Barre syndrome, stroke, encephalitis, paraplegia, and CP. Of note, this study was reported as having unclear or positive outcomes, depending on which of 2 systematic reviews16,19 were considered. After reviewing the results, we recorded statistically significant changes in both the 6-minute and 10-m walk tests as well as category D of the GMFM. Finally, de Bode et al59 examined the use of mixed methods of TT in children who had undergone hemispherectomies due to a prenatal stroke, cortical dysplasia, or Rasmussen syndrome and found a number of positive outcomes in the BS and F dimension.
In this overview, we examined the evidence presented in 5 available systematic reviews about the effects of TT with or without PBWS in children with motor impairments. Although all reviews claimed to include studies regarding PBWSTT in children with CP (with 2 reviews also including other diagnoses and 3 reviews including other variations of TT), the number of studies included in all reviews was surprisingly low. Only 1 study4 was included in all 5 reviews, and only 4 studies4,34,39,42 were common in the 4 reviews published in 2009.16–19 However, the quality of the reviews was relatively high, with the 4 reviews scoring in the medium- to high-quality range.16–19 Of interest, however, is that 119 of the 2 reviews scoring the highest AMSTAR score did not include 2 studies27,37 examined in all of the other systematic reviews, despite a seemingly comprehensive search of the literature. One study37 may have been excluded on the basis of the PEDro score of 2 reported in another systematic review,16 but the other study seemingly met their inclusion criteria.27 In addition, this same systematic review was the only review not to report levels of evidence for the included studies. Surprisingly, there were many discrepancies across systematic reviews in the level of evidence assigned to each study and how the outcomes were interpreted. Regardless, authors of the 5 systematic reviews concluded that TT in its different forms appears to be safe in children with motor impairments and that results are encouraging, primarily in BS and F outcomes.13,16–19 All authors, however, agreed that there still is insufficient evidence to confidently conclude that TT training has positive effects on walking in children with CP,13,16–19 other CNS impairments,13,16 and SCI.16 Evidence for TT for children with DS is supported in 1 high-quality 2009 review16; however, this evidence is based on the same 2 samples of children with DS with outcomes only in the BS and F domain.
A high number of studies regarding the use of different varieties of TT have been conducted in children with CP. Unfortunately, the levels of evidence of these studies continue to mostly be at a level of IV or V, with only 1 study at a level II and 1 at a level III. However, overall results are encouraging in both the BS and F, and A and P components of the ICF. In particular, improvements in temporal-spatial characteristics of gait, 10-m walk test, and GMFM scores show the most consistency between studies. Less evidence exists on the effect of TT on participation of children with CP. In terms of parameters of intervention, studies have been so highly variable in their use of different types of TT, speed, BWS, time per session, and frequency and duration that it is currently not possible to suggest which parameters might be responsible for creating positive outcomes.
The highest levels of evidence for the use of TT in children with motor impairments exist in children with DS. Six studies, albeit from only 2 samples, suggest a number of statistically significant results in BS and F when using TT only in infants with DS. However, a significant lack of evidence exists regarding the effects of TT on A and P in these children, an important gap in currently available research. Intervention parameters in this population have been quite similar and suggest that intervention using a speed of approximately 20 cm/s for 6 to 9 minutes per day until the achievement of independent walking can have important effects on BS and F outcomes; these range from temporal-spatial characteristics of gait, to obstacle negotiation strategies, and to the number of days taken to achieve walking with or without assistance.
Research regarding the effectiveness of different types of TT in children with SCI is beginning to emerge and suggests encouraging results. All studies pertaining to SCI utilized 1 or more modes of PBWSTT with a BWS percentage starting around 40% to 80% and decreasing as the intervention period progressed. Intervention was 3 or more times per week for greater than 8 weeks in duration.
Lastly, additional results are available for children with motor impairments resulting from CNS disorders, as well as from studies including children with mixed diagnoses. A number of small studies with levels of evidence ranging from III to V suggest that different types of TT may be of benefit in a variety of children with different neuromotor impairments. Again, parameters for intervention in these studies have been highly variable, and it is therefore not possible to make evidence-based decisions as to which parameters are more likely to lead to positive outcomes.
Implications for Research
Although there have been a number of recently published studies regarding the effectiveness of TT in children with motor impairments, a significant lack of evidence exists regarding the effects of any TT intervention on the participation element of A and P. If enhanced participation is to be viewed as the ultimate goal of rehabilitation, measurement of participation level outcomes is necessary.60 Considering the existing literature supporting the use of individualized goals in evaluating therapy program for children with disabilities,60,61 their use is surprisingly lacking in current research on TT. Adding an individualized criterion-referenced measure of change, such as goal attainment scaling,62 to future research, would determine if TT has an effect on child and family goals, an important indicator of success for any intervention. Lastly, further research is needed to assist clinicians in determining best practice guidelines in terms of parameters for TT for children with CP, other CNS impairments, and SCI.
A number of systematic reviews of varying quality on TT (with and without PBWS) in children with neuromotor impairments have been published. This overview has shown that there were inconsistencies in terms of study inclusion, interpretation of levels of evidence, and significance of outcomes across systematic reviews. In summary, much of the research on TT has been on children with CP, with the majority of evidence at levels IV and V. The most consistent and statistically significant improvements are noted in GMFM D and GMFM E scores with PBWSTT and TT. Despite promising results, randomized controlled trials with larger sample sizes are required to increase confidence in these findings. A recently published, randomized, controlled trial of PBWSTT in children with CP reported no advantage of PBWSTT overground walking in improving walking speed, endurance, and walking function; however, this study may have been underpowered to detect significant differences between groups because of the smaller than expected sample size.63 Weak and inconclusive evidence exists for robotic-assist PBWSTT for children with CP. The highest level of evidence of TT has been shown in infants with DS but is limited to 2 samples of children and with no measures of activities and participation. A recently published randomized controlled trial comparing TT with and without orthoses adds to the literature that TT is beneficial for infants with DS.64 No TT studies have been published on older children with DS. Insufficient evidence exists to conclude if any form of TT is effective for children with SCI or CNS impairments.
The authors express appreciation to Doug Salzwedel, clinical librarian, for his assistance with electronic database searches.
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