Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy
Cerebral Palsy
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility 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. -
Sites / Locations
- Shirley Ryan AbilityLabRecruiting
- University of AlbertaRecruiting
- Holland Bloorview Kids Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
No Intervention
Lokomat (LOK)
Gait focused physical therapy (fPT)
LOK + fPT
Maintenance therapy
Two 50-minute sessions per week. The manualized LOK walking protocol provides methods for progressing/tracking including a 5-minute overground walking session after the LOK to facilitate transfer of motor learning from the LOK to usual walking devices. The goal-based LOK program uses a standardized approach to progressing LOK body weight and guidance support and includes upper body activities while walking to encourage dual tasking and improved posture, and motor imagery practice.
Two 50-minute sessions per week. Each weekly fPT session consists of 50 minutes of active treatment, a 'dose' equivalent to time spent in active treatment in the LOK arm. Techniques that focus on body structure changes will be not be permitted (e.g., inhibitive casting, kinesiotaping, functional electrical stimulation).
Two 50-minute sessions per week. Children will receive both the LOK and the fPT protocols (content as described above for each) for the duration of the 8 to 10 week intervention phase. These will be given as two sessions of LOK one week alternating with two sessions of fPT the next week. The fPT will build on motor learning principles because the activities will allow the child to practice motor skills in a variety of different activities. Techniques focusing on body structure changes will be prohibited.
Consists of maintenance therapy and a weekly email from the centre's research assistant to monitor any co-interventions. Maintenance may include range of motion/stretching and basic isometric strength home program as well as up to 10 minutes per day of exercise bicycle or treadmill or general walking practice.