Robotic gait training and physical therapy for children with cerebral palsy
Evaluation of the Effectiveness of Robotic Gait Training and Gait-focused Physical Therapy Programs for Children and Youth With Cerebral Palsy: A Mixed Methods Randomized Controlled Trial
This study tests whether robotic gait training, regular physical therapy, or a mix of both can help children with cerebral palsy walk better and move more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT02391324 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of robotic gait training using the Lokomat® device compared to functional physical therapy and a combination of both for children and youth with cerebral palsy. The study involves a randomized controlled trial (RCT) with four groups: robotic training, functional therapy, combined therapy, and a maintenance therapy condition. Each intervention consists of sixteen 50-minute sessions over 8 to 10 weeks, aiming to improve walking abilities and functional mobility. Additionally, a qualitative study will gather insights on family experiences with the interventions.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-18 years with a diagnosis of cerebral palsy at GMFCS Levels II and III who can participate in physical therapy.
Not a fit: Patients with severe mobility impairments (GMFCS Levels IV and V) or those unable to participate in the required therapy sessions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance walking abilities and overall mobility in children with cerebral palsy.
How similar studies have performed: Other studies have shown promise in using robotic gait training for similar populations, but this is one of the first adequately powered RCTs to evaluate its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of CP (any type), GMFCS Levels II and III * Able to follow GMFM testing instructions, and to participate in a minimum of 30 minutes of active PT (as judged by the child's PT or physician if not followed by a PT) * Able to reliably signal pain, fear and discomfort using verbal or nonverbal signals * Passive range of motion (ROM) of hips and knees within minimum range requirement for LOK (hip and knee flexion contracture \< 10 degrees, and knee valgus \< 40 degrees). * Parent/child agrees to attend 16 study intervention sessions (given within two 10-week periods), a LOK fitting/acclimatization session or fPT acclimatization session and the three assessment sessions during the course of the study. * Parent agrees to contact of their primary PT (if not already involved by parent in the screening process) and their paediatrician or physiatrist to confirm eligibility. * Parent agrees that regular PT (and other gross motor mobility therapies such as conductive education and MEDEK) will be discontinued from the time of the baseline assessment through the 8 to 10 weeks of the active intervention or control group. Note that home programs such as stretching and strengthening and treadmill and exercise bike riding (no more than 10 minutes total per day) will be permitted in all groups. Exclusion Criteria: * Botulinum Toxin injection within the past 4 months or planned within the next 6 months * Fixed knee contracture \> 10 degrees, knee valgus \>40 degrees such that orthosis will not be adaptable to lower limbs. * Hip instability/subluxation as demonstrated by a migration percentage \> 45% * Orthopaedic surgery (soft tissue releases) within the last 9 months, or lower limb bony surgery within the last 18 months * Severe spasticity may be a contraindication as determined in Lokomat trial session using L-FORCE assessment. * Any weightbearing restrictions. * Seizure disorder unless fully controlled by medication and no evidence of seizure in the last 12 months and physician provides singed approval to enter the study * Open skin lesions or vascular disorder of lower extremities * Not able to co-operate or be positioned adequately within the LOK as shown during the fitting/acclimatisation session. -
Where this trial is running
Chicago, Illinois and 2 other locations
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Holland Bloorview Kids Rehabilitation Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Virginia Wright, PhD — Holland Bloorview Kids Rehabilitation Hospital
- Study coordinator: Lesley Wiart, PhD
- Email: lwiart@ualberta.ca
- Phone: 780-492-2971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.