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RESEARCH REPORTS

A Home-Based Body Weight-Supported Treadmill Program for Children With Cerebral Palsy: A Pilot Study

Visser, Allie PT, DPT; Westman, Marci PT, DPT; Otieno, Sango PhD; Kenyon, Lisa PT, DPT, PhD, PCS

Author Information
doi: 10.1097/PEP.0000000000000406

INTRODUCTION

Cerebral palsy (CP) is the most common motor disability in childhood, with an overall estimated prevalence of 2.11 per 1000 live births.1 Attaining or improving ambulation is often a desired outcome for children with CP.2 Although approximately 70% of children with CP will achieve independent ambulation or walk using a hand-held mobility device,3 gait abnormalities and difficulties are commonly observed in CP.4 Energy expenditure during gait may be increased by as much as 3-fold in children with CP as compared with children who are typically developing.4 Decreased ambulatory function has also been associated with activity limitations and participation restrictions in children who have CP.5

In addition to deficits in ambulatory function, children with CP often have lower levels of functional exercise capacity than their peers developing typically6 and yet may have difficulties sustaining activity at the intensity and duration necessary to improve endurance and fitness.7 Energy expenditure and other neuromuscular impairments associated with CP may contribute to disuse and deconditioning, resulting in a cycle of further impairment and greater mobility restrictions.6,8 To improve overall health and wellness and prevent further deconditioning, there is a substantial need for safe, enjoyable, and feasible exercise programs for children with CP.

Body weight-supported treadmill training (BWSTT) is a procedural intervention typically performed in a clinical setting using a harness around the trunk that is suspended from an overhead structure to fully or partially unweight a person while walking on a treadmill. BWSTT is a task-specific, repetitive activity that requires active participation and allows practice stepping without risk of falling and without the increased effort and exertion of overground walking with full weight bearing.2 Multiple studies suggest that BWSTT may improve functional mobility and endurance in children with CP.2,9–13 Mattern-Baxter2 concluded that BWSTT was potentially beneficial for children with different types of CP at various levels of severity and may be especially helpful in attaining walking as well as improving gait speed and endurance.

Home-based treadmill stepping programs have been successfully implemented for infants with Down syndrome14; however, few studies have focused on the use of home-based treadmill programs for children with CP.9,12 Johnston et al12 found improvements in gait and gross motor function in children with CP following a speed-based BWSTT program that included a twice daily, 2-week introduction of BWSTT under the direct supervision of a therapist before beginning the program in a home setting. In another study, young children with CP at Gross Motor Function Classification System (GMFCS)15 levels I and II improved in gait and gross motor skills following a home-based treadmill walking program.9 Given the potential benefits of BWSTT, it was hypothesized that a BWSTT program implemented entirely as a home-based program might be helpful for improving function in children with CP. The purpose of this pilot study was to examine the effect and feasibility of a 12-week home-based BWSTT program on walking capacity and functional mobility in children with CP. The following hypotheses were tested: (1) walking capacity and functional mobility would improve following participation in the 12-week home-based BWSTT program; (2) scores obtained for walking capacity and functional mobility would demonstrate a positive moderate correlation (r ≥ 0.5) following the 12-week program, and (3) the program would be feasible to conduct in the home setting as determined by adherence to the program.

METHODS

A within-subjects, repeated-measures design was used to conduct this pilot study. Approval for the study was obtained from the relevant Institutional Review Boards. Parental permission was obtained for all participants and assent was obtained for all participants 7 years or older who were able to provide assent. A sample of convenience was recruited from throughout the state. The desired sample size was determined to be 12 assuming a large effect size of 0.8 (α = 0.05, and power = 0.80).16 Inclusion criteria were a diagnosis CP, GMFCS levels II to III, access to a treadmill, the ability to take unassisted steps on a treadmill when supported by a harness, and the ability to follow simple instructions. Exclusion criteria were medical restrictions on physical activity, surgical intervention within 3 months, orthopedic or neurosurgery within 6 months, and acute injury impacting ambulation.

Outcome Measures

Pre- and postintervention testing was conducted by a pediatric physical therapist resident who was trained in test administration procedures and was directly supervised by a pediatric clinical specialist with 30 years of pediatric clinical and research experience. Pre- and postintervention testing occurred within a 7- to 10-day period of initiating and concluding the 12-week treadmill training program. The following outcome measures were used: the 6-minute walk test (6MWT),17 the Physiological Cost Index (PCI) using the formula developed by Butler et al18—PCI = (HR(w) − HR(r))/speed of walking—the Functional Mobility Scale (FMS),19 the Mobility domain of the Pediatric Evaluation of Disability Inventory—Computer Adaptive Test (PEDI-CAT),20 the Gillette Functional Assessment Questionnaire Walking Scale (FAQ),21 and parent-identified occupational performance issues in the area of functional mobility as identified by the Canadian Occupational Performance Measure (COPM).22 Supplemental Digital Content 1 (available at: https://links.lww.com/PPT/A159) includes details of the reliability and validity of these measures. Outcome measures were administered in a computer-generated randomized order with the 2 walking tests (6MWT and PCI) randomly administered either first or last to allow participants time to rest and recover between walking tests. For the PCI, heart rate values were obtained using a Garmin Forerunner 225 watch with a Garmin heart rate monitor (Garmin International, Inc, Olathe, Kansas) donned at the level of the xiphoid process.

Home-Based BWSTT Intervention Program

The Wingman MultiSport Harness (Wingman Harness Company, LLC, Springfield, Missouri) and accompanying Ceiling Mounting Kit were used to provide the BWSTT program and supplied at no cost to the families. Families were responsible for purchasing and installing an eyehook (available locally for approximately $6.99) that met specifications provided by the Wingman Harness Company, LLC (e-mail communication, July 28, 2013). The specifics of the home-based BWSTT program were developed on the basis of evidence from literature on BWSTT programs for children with cerebral palsy2,9–13 and in consideration that the program would be carried out at the participants' homes. Recent literature supported the home-based program as a way to eliminate common personal and environmental barriers to physical activity such as lack of access to transportation, inconvenient schedules and time constraints, and fear of injury.23 An initial 60-minute home visit focused on instructing the parent/caregiver in implementation of the home-based program was conducted by one of the physical therapist residents. During this home visit, the safety of the eyehook was tested per specifications provided by Wingman Harness Company, LLC (e-mail communication, July 28, 2013). The harness also was fitted per the manufacturer's instructions, and the suspension strap component of the Ceiling Mounting Kit was adjusted such that each participant was able to stand erect and support a majority of his/her weight with feet flat on the treadmill. Treadmill speed and the amount of weight supported by the harness were then set so that each participant was able to maintain a fluid stepping motion while accepting weight during stance phase with a heel-toe or foot-flat contact pattern and achieving knee extension to approximately 10° to 15° at midstance.12 Each participant used any typical lower extremity orthoses and customary shoes during all BWSTT activities. Upper extremity support was used as desired by each participant. Once each participant was positioned appropriately within the harness system, the family was instructed in safely carrying out the program. The duration of the initial BWSTT session was determined on the basis of the researcher's observation that the participant was no longer able to sustain an appropriate stepping pattern or that the participant was having difficulty consistently initiating steps. Motivational activities to engage or distract each participant during the treadmill program were discussed with each family, and parents or caregivers were educated on signs and symptoms of fatigue that warranted early termination of a session or medical attention.

Following this initial home training session, the 12-week BWSTT program was conducted 3 to 4 times per week by a parent or caregiver of each participant. Parents or caregivers steadily increased the length of the sessions as tolerated, with the goal of achieving a duration of 20 minutes for the 3 to 4 sessions per week. The parent or caregiver was provided with an intervention log and asked to record the duration of each session, the distance walked, the speed of the treadmill, the number and duration of rest breaks, motivational strategies used during the session, and other observations made during the session. The researchers contacted each participant's family weekly via phone or e-mail to ensure that questions and concerns were addressed and that the intervention was being conducted as instructed.

Statistical Analysis

Means and standard deviations were calculated for all variables. Data were evaluated for normality and symmetry to ensure that use of parametric statistics was appropriate. One-tailed, paired t tests were then used to examine differences between pre- and posttesting. The Statistical Analysis System (SAS) version 9.4 (SAS Institute, Inc, Gary, North Carolina) was used. The α level was set at P < .05. Effect size and observed power were determined. Effect sizes were interpreted as small = 0.20 to 0.50; moderate = 0.50 to 0.80; and large more than 0.80.16 Pearson correlation coefficients were used to determine the degree of association between postintervention variables.16 To correct for the use of multiple statistical tests, a Bonferroni correction (significance level = 0.05/number of tests) was used as appropriate.

RESULTS

Ten children with CP ages 6 to 16 years participated in the study (Figure 1, Table 1). As measured by parent report and documented using the intervention logs, the mean number of BWSTT sessions per week for the group was 3.03 and the mean total walking time per BWSTT session for the group at the completion of the intervention program was 15.19 minutes. Six of the 10 participants (60%) achieved the mean recommended frequency of 3 to 4 times per week for the 12-week duration. Six of the 10 participants (60%) achieved a mean total walking time of 20 minutes per session by the end of the 12-week intervention period (Supplemental Digital Content 2, available at: https://links.lww.com/PPT/A160 for participant detail).

F1
Fig. 1.:
Participant flow chart.
TABLE 1 - Participant Characteristics at the Onset of the Study
Participant Age Type of CP GMFCS15 Level MACS24 Level CFCS25 Level Primary Ambulatory Status
Participant 1 16 y, 1 mo Spastic triplegia II I I Independent
Participant 2 16 y, 1 mo Spastic triplegia III III IV Lofstrand crutches
Participant 3 6 y, 8 mo Spastic diplegia III II I 4-wheeled posterior walker
Participant 4 15 y, 11 mo Spastic diplegia III II I 4-wheeled posterior walker
Participant 5 6 y, 6 mo Spastic diplegia II I I Independent
Participant 6 13 y, 10 mo Spastic diplegia II I I Independent
Participant 7 6 y, 4 mo Hypotonia/ataxia III II II 4-wheeled posterior walker
Participant 8 14 y, 8 mo Spastic quadriplegia III II I 4-wheeled posterior walker
Participant 9 6 y, 2 mo Spastic triplegia II I I Independent
Participant 10 16 y, 5 mo Spastic diplegia II I III Independent
Abbreviations: CFCS, Communication Function Classification System; CP, cerebral palsy; GMFCS, Gross Motor Function Classification System; MACS, Manual Ability Classification System.

The data were evaluated for normality and symmetry as detailed in Supplemental Digital Content 3 (available at: https://links.lww.com/PPT/A161). Standardized values for skewness and kurtosis were less than 1.96. Although the Shapiro-Wilk tests demonstrated a lack of normality with P values < .05 for several variables, extreme outliers were not identified in the data. On the basis of these factors, data analysis proceeded using 1-tailed, paired t tests. Results are in Table 2. Change scores between pre- and posttesting for each participant can be found online in Supplemental Digital Content 3 (available at: https://links.lww.com/PPT/A161).

TABLE 2 - Differences Between Pre- and Posttesting
Variable Mean Standard Deviation 95% Confidence Interval for the Mean of the Pairwise Difference Paired t-Test Statistic, P value Effect Size Observed Power
Lower Upper
6MWT
Pre 198.22 105.98
Post 275.16 115.38
Post/pre 76.94 50.61 40.74 113.1 4.81, .0005a 1.53 0.99
PCI
Pre 2.19 1.15
Post 1.52 1.14
Post/pre -0.67 0.28 −0.87 −0.47 −7.54, <.0005a 2.38 1.00
PEDI-CAT Mobility domain
Pre 60.0 3.23
Post 59.4 4.55
Post/pre −0.60 2.12 −2.12 0.92 −0.90, .197 0.28 0.13
COPM performance
Pre 3.72 1.21
Post 6.28 1.14
Post/pre 2.56 1.97 1.15 3.97 4.11, .0013a 1.30 0.96
COPM satisfaction
Pre 3.74 1.33
Post 6.84 1.70
Post/pre 3.10 2.05 1.63 4.57 4.77, .0005a 1.51 0.99
FMS: 5 m
Pre 4.30 1.64
Post 4.80 1.40
Post/pre 0.50 0.71 −0.01 1.01 2.24, .026 0.71 0.51
FMS: 50 m
Pre 3.40 1.51
Post 4.30 1.49
Post/pre 0.90 1.00 0.19 1.61 2.86, .0095 0.91 0.72
FMS: 500 m
Pre 2.90 1.66
Post 3.60 1.90
Post/pre 0.70 1.06 −0.06 1.46 2.09, .0331 0.66 0.46
FAQ
Pre 7.10 1.29
Post 8.20 0.92
Post/pre 1.10 1.20 0.24 1.96 2.91, .0087 0.92 0.73
Abbreviations: 6MWT, 6-minute walk test; COPM, Canadian Occupational Performance Measure; FAQ, Gillette Functional Assessment Questionnaire; FMS, Functional Mobility Scale; PCI, Physiological Cost Index; PEDI-CAT, Pediatric Evaluation of Disability Inventory—Computer Adaptive Test.
aStatistically significant.

There were significant differences between pre- and posttesting for the 6MWT, the PCI, and the COPM for both performance and satisfaction (Table 2). There were no significant differences between pre- and postintervention testing for the Mobility domain of the PEDI-CAT, the FAQ, or the FMS at distance (Table 2). There were large effect sizes for the 6MWT, the PCI, the COPM for both performance and satisfaction, the FMS at 50 m, and the FAQ. There was a moderate effect size for the FMS at the 5 and 500 m. There was a small effect size for the PEDI-CAT Mobility domain.

Results for the posttreatment relationship between walking capacity as measured by the 6MWT and the PCI and functional mobility as measured by the COPM for both the performance and satisfaction, the FMS at a distance of 5, 50, and 500 m, and the FAQ are included in Table 3. There was a high correlation between the 6MWT and the FMS at all distances and between the PCI and the FMS at a distance of 50 m. There was a high correlation between the PCI and the FAQ, which was not statistically significant. There was a moderate correlation16 between the 6MWT and the FAQ and between the PCI and the FMS at 5 and 500 m. There were weak or no correlations between the 6MWT and the COPM for either performance or satisfaction, whereas a fair correlation was found between the PCI and the COPM for both performance and satisfaction.

TABLE 3 - Relationship Between Walking Capacity as Measured by the 6MWT and the PCI and Functional Mobility as Measured by the COPM, the FMS, and the FAQa
COPM—Performance Post COPM—Satisfaction Post FMS: 5 m Post FMS: 50 m Post FMS: 500 m Post FAQ Post
r Value p Value r Value P Value r Value P Value r Value P Value r Value P Value r Value P Value
6MWT Post 0.06 .861 0.20 .575 0.81 .004b 0.79 .007b 0.87 .001b 0.53 .119
PCI Post −0.33 .352 −0.41 .445 −0.61 .062 −0.78 .008b −0.70 .024 −0.76 .010
Abbreviations: 6MWT, 6-minute walk test; COPM, Canadian Occupational Performance Measure; FAQ: Gillette Functional Assessment Questionnaire; FMS, Functional Mobility Scale; PCI, Physiological Cost Index.
ar values calculated using a Pearson correlation coefficient.
bStatistically significant.

Parents reported relevant improvements for several participants. Two of the 10 participants (Participants 3 and 7) decreased the amount of support needed when ambulating. At the onset of the study, both of these participants required use of a posterior walker for ambulation. At the end of the intervention period, Participant 3 had progressed to bilateral walking poles as primary means of mobility and Participant 7 no longer required an assistive device for ambulation.

Feasibility Assessment

It is relevant to examine study factors related to process, resources, management, and method that may impact or possibly enhance a future study. Only 10 of the desired 12 participants were recruited for the study. Inclusion criteria included access to a treadmill and exclusion criteria excluded participants who had surgical intervention within the past 3 months and orthopedic or neurosurgery within the past 6 months. These may have deterred some families from seeking information about the study. The amount of family involvement and the time commitment required of both families and participants may have discouraged some families. Flexibility in scheduling pre- and postintervention testing and the initial home visit during evening and weekend times appeared to assist families in making and keeping study-related appointments and may have assisted with retention. Overall compliance to the home-based program was fair; however, increased compliance (increased frequency and longer duration of sessions) may have made more of an effect on the targeted outcomes. Future studies will also have to consider the current cost of the Wingman Harness and Ceiling Mount Kit.

Every measure was taken to ensure that the program could be easily conducted by the families and that potential barriers to physical activity in children with CP were addressed.23,26 The fact that the families could perform the program around their schedules at times that worked best for both the family and the child may have lessened the potential effect of fatigue as a personal barrier to physical activity.23 One family reported this as a major benefit as their child had previously attempted to participate in physical activities available in the community but was often too tired to participate at the scheduled times. Future research involving a home-based BWSTT program should consider whether compliance could be increased by identifying family- and participant-specific barriers to physical activity and incorporating these into the study activities.

DISCUSSION

This pilot study supports that a 12-week home-based BWSTT program is effective in improving walking capacity and functional mobility in children with CP (GMFCS levels II-III). Statistically significant improvements in group scores on the 6MWT, the PCI, and the COPM for both the performance and satisfaction appear to support the hypothesis that both walking capacity and functional mobility could improve following participation in the 12-week home-based BWSTT program. In addition, postintervention scores obtained for the 6MWT and the PCI demonstrated at least a moderate correlation with the FMS and FAQ, thereby suggesting a relationship between walking capacity and functional mobility. Given the program adherence rates and that all of the participants completed the study, the hypothesis that the 12-week program would be feasible to carry out in the home setting also appears to be supported.

The findings of improved walking capacity and functional mobility attained in this home-based BWSTT were similar to findings of BWSTT programs conducted for children in CP in non-home-based settings.2,10,11,13 Provost et al10 reported improved functional mobility and energy expenditure in children with CP (GMFCS level I) following completion of a 2-week intensive clinic-based BWSTT program conducted twice daily for 30 minutes. Dodd and Foley13 also described improvements in walking capacity and endurance following completion of a school-based BWSTT program for children with CP (GMFCS levels III and IV). Although the BWSTT program used in this pilot study differed in intensity and structure from the home-based treadmill programs used in other studies,9,12 the improvements in functional mobility observed in this pilot study are consistent with findings of home-based treadmill programs in studies by Johnston et al12 and Mattern-Baxter et al.9 In addition, the improvements observed in this pilot study also are congruous with improvements observed in studies focused on enhancing cardiovascular fitness6,27 and increasing physical activity8 in children with CP.

Home-based therapy programs conducted by family members and caregivers are often used to help carry over and reinforce therapeutic activities and goals.26 Similar to the opportunities provided in this pilot study, such programs may offer children the opportunity for increased repetition and allow children to practice motor tasks in their own environment.26,28 Novak and Berry26 suggest that evidence-based home-based programs focused on repetition of functional tasks and movements, such as the program used in this pilot study, may improve motor outcomes in children with CP. These concepts are illustrated in this pilot study and in a feasibility study by Katz-Leurer et al28 in which a home-based functional exercise program improved balance and gait performance in children with CP or brain injury.

Research indicates that many older children and adolescents with CP often experience a decline in gross motor skills and ambulatory function.29 Given recent research suggesting that physical activity may contribute significantly to the prevention of chronic pain, fatigue, and deterioration of functional locomotor skills in adults with CP,8 a home-based BWSTT program may help enhance independence and increase participation as children with CP age. Further research is needed to investigate the long-term effect of a home-based BWSTT on walking capacity and functional mobility as related to the development of secondary impairments and maintenance of functional capacity.

Limitations

As to be expected, this pilot study had limitations. The small sample size inherent in a pilot study limits interpretation and generalizability of the results. This study also only focused on BWSTT for children with CP at GMFCS levels II to III and therefore cannot be generalized to children with other GMFCS levels. Given the cluster of participants in the pilot study into 2 age groups (4 younger children of approximately 6 years of age and 6 teenagers ages 13-16 years), internal validity may have been impacted by a cofounding variable of age as well as by the lack of a blinded assessor. The within-subjects design lacked a control group, and other forms of physical activity or therapy in which participants may have been involved were not monitored during the study.

CONCLUSIONS

This pilot study supported that a 12-week home-based BWSTT program improved measures of walking capacity and functional mobility in a small sample of children with a diagnosis of CP, GMFCS levels II to III, and ages 6 to 16 years. On the basis of this pilot study, further research is warranted to continue investigating the potential effects of a home-based BWSTT program on walking capacity and functional mobility in children with CP. Research into various durations and intensities of home-based BWSTT will help identify specific parameters that clinicians can use to help children with CP achieve the best outcomes regarding walking capacity and functional mobility.

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      Keywords:

      body weight-supported treadmill training; cerebral palsy; functional mobility; walking capacity

      Supplemental Digital Content

      © 2017 Wolters Kluwer Health, Inc. and Academy of Pediatric Physical Therapy of the American Physical Therapy Association