Status:
COMPLETED
A Randomized Trial Comparing the Lokomat® With a Gait-related Physiotherapy Program in Children With Cerebral Palsy
Lead Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Collaborating Sponsors:
CIBC Children's Foundation
Conditions:
Cerebral Palsy
Eligibility:
All Genders
5-12 years
Phase:
PHASE2
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 ...
Detailed Description
No further information
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02196298
Start Date
October 1 2012
End Date
January 30 2017
Last Update
January 31 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Holland Bloorview Kids Rehabiltation Hospital
Toronto, Ontario, Canada, M4G 1R8