The Lokomat is a robotic treadmill gait trainer that is used to help people who have neurologic conditions walk better. Early research with children with cerebral palsy (CP) shows that it may help to improve walking skills. The purpose of this two-group randomized study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on walking abilities and related function. The primary (alternate) hypothesis is that children will improve more with Lokomat training in terms of gross motor skills and walking endurance. The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20). In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done first is decided by an independent randomization process that occurs after the first baseline assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35 minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions, and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities. There is a 6 week break between the Lokomat and PT interventions. Each child has four study assessments during their \~6 months in the study. The first assessment is done before starting the Lokomat or physiotherapy phase. The second happens after the first intervention has finished. The child then has a 6-week break period. The third assessment is done at the end of this break, and the fourth occurs after the second intervention. The PT assessor who does these assessments will not be the same as the PT who gives the intervention. The assessor is blinded to the child's intervention phase and previous assessment results. The primary outcome measures are the Gross Motor Function Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities, participation, health related quality of life and individualized goals. The randomized aspect of the study lets us look at outcome differences between children for Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase evaluates within-child outcomes across the two phases. A qualitative component is concurrently underway to examine child/parent experiences and their views of Lokomat outcomes.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
Holland Bloorview Kids Rehabiltation Hospital
Toronto, Ontario, Canada
Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8
Stand and Walk items of the GMFM-66. Gold standard measure of foundational gross motor skills in children with CP.
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in walk speed on the Six-minute walk test at week 8
Used as the co-primary outcome measure. Standardized 6 minute walk test (with shoes, orthoses, walking devices as required) to determine distance covered (capability measure). Well-validated in pediatric CP.
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in advanced motor skills on the Challenge Module at week 8
Just for children in GMFCS Level II. This is a new published measure of advanced motor skills.
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in activity and participation on the Activities Scale for Kids at week 8
Well-validated measure of physical functional ability in children. Child (if 8+ years) or parent-report questionnaire
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in quality of life on the KidScreen Questionnaire at week 8
Measure of health-related quality of life. Questionnaire completed by children 8+ years or parents of younger children.
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in participation on the Children's Assessment of Participation and Enjoyment (CAPE) at week 8
Using the physical activity and sport sections of this parent-report questionnaire to gain picture of areas/extent of participation in these areas.
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8
Time distance parameters of gait via GaitRite system
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in Gait quality as measured on an observational gait scale at week 8
Gait pattern as evaluated via observational gait scale, rating from video of child's walking
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) at week 8
Three to five individualized walking-based activity/participation goals set with child/parent/treating PT at baseline 1 and reset at baseline 2. Evaluated by treating PT with child/parent input at post-intervention 1 and 2
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8
Three to five individualized walking-based activity/participation set at baseline 1 and 2 with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessment 1 and 2. Used by treating PT to formulate GAS goals
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
Change from baseline in movement quality as measured by the Quality Function Measure (QFM) at week 8
Companion measure to the GMFM-66 to assess alignment, co-ordination, dissociated movement, stability and weight shift. Rated by PT assessor from GMFM video. Recently validated.
Time frame: Baseline, 8 weeks (repeated in same manner after crossover)
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