A Randomized Trial Comparing the Lokomat® With a Gait-related Physiotherapy Program in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      No further information
    

Intervention name(s): Lokomat; Physiotherapy
Intervention type(s): Device; Other
Intervention description(s): 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.
Other intervention name(s): Lokomat®Pro Pediatric Orthoses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: physical therapy; gait; pediatric rehabilitation; gross motor function; participation