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Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy

Cerebral Palsy

Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and contextual factors that influenced participation in the study. This research will provide information needed to allow clinicians and families to make informed choices about Lokomat therapy and physical therapy options in relation to their child's functional goals and abilities.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    5 to 18

Participation 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. -

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Pegah Firouzeh, MSc

[email protected]
780-492-9098
Holland Bloorview Kids Rehabilitation Hospital
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Gloria Lee

[email protected]
416-425-6220
Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: NCT02391324