Clinical trial NCT02196298: A Randomized Trial Comparing the Lokomat® With a Gait-related Physiotherapy Program in Children With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: physical therapy
gait
pediatric rehabilitation
gross motor function
participation
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: CIBC Children's Foundation
First posted: 2014-07-22
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* age 5 to12 years inclusive
* assessed as GMFCS Levels II or III
* able to follow testing instructions, and participate in a minimum of 30 minutes of active PT
* able to reliably signal pain, fear and discomfort
* have passive range of motion (ROM) of hips and knees within minimum range requirement for Lokomat (hip and knee flexion contracture \< 10 degrees, and knee valgus \< 40 degrees)
* client of Child Development Program at Holland Bloorview
* able to commit to attendance of twice weekly for eight weeks (to support the primary efficacy analysis).

Exclusion Criteria:

* a fixed knee contracture \> 10 degrees, knee valgus \>40 degrees such that robotic leg orthosis will not be adaptable to lower limbs
* hip instability/subluxation \> 45%
* orthopaedic surgery within the last 9 months (muscle) or 12 months (bone)
* Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months
* inability to discontinue BTX-A for period of 6 months (during trial) due to concerns about ROM or pain
* severe spasticity may be a contraindication
* any weightbearing restrictions
* seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months)
* open skin lesions or vascular disorder of lower extremities
* not able to co-operate or be positioned adequately within the Lokomat as shown during the two Lokomat fitting/acclimatisation sessions
* not prepared or unable to discontinue a regular therapy intervention during the course of the trial
* involved in another intervention study

Primary outcomes:
measure: Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
Secondary outcomes:
measure: Change from baseline in walk speed on the Six-minute walk test at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in advanced motor skills on the Challenge Module at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in activity and participation on the Activities Scale for Kids at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in quality of life on the KidScreen Questionnaire at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in participation on the Children's Assessment of Participation and Enjoyment (CAPE) at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in Gait quality as measured on an observational gait scale at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
measure: Change from baseline in movement quality as measured by the Quality Function Measure (QFM) at week 8
timeFrame: Baseline, 8 weeks (repeated in same manner after crossover)
Other outcomes:
measure: Assessment of mastery motivation using the Dimensions of Mastery Questionnaire at the first baseline
timeFrame: Baseline 1 only
measure: Monitoring of range of motion (ROM) of hip, knee and ankle
timeFrame: baseline, 4 weeks, 8 weeks (repeated in same manner after crossover)
measure: Body pain
timeFrame: participants will be followed at each treatment session for the duration of the study, an expected average of 16 weeks (8 weeks in the Lokomat arm and 8 weeks in the PT arm)
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabiltation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabiltation Hospital
name: Virginia Wright, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Holland Bloorview Kids Rehabiltation Hospital
name: Darcy Fehlings, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilderley AJ, Fehlings D, Lee GW, Wright FV. Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.
citation: Phelan SK, Gibson BE, Wright FV. What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Disabil Rehabil. 2015;37(24):2272-81. doi: 10.3109/09638288.2015.1019648. Epub 2015 Apr 9.
citation: Beveridge B, Feltracco D, Struyf J, Strauss E, Dang S, Phelan S, Wright FV, Gibson BE. "You gotta try it all": Parents' Experiences with Robotic Gait Training for their Children with Cerebral Palsy. Phys Occup Ther Pediatr. 2015;35(4):327-41. doi: 10.3109/01942638.2014.990547. Epub 2014 Dec 20.