Cerebral Palsy Clinical Trial
Official title:
A Randomized Cross-over Clinical Trial Comparing the Impact of the Lokomat® Gait Training System With a Gait-related Physiotherapy Program in Children With Cerebral Palsy
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.
No further information ;
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