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Robotic Gait Training + Physical Therapy for Cerebral Palsy

N/A

Recruiting

Led By Lesley Wiart, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CP (any type), GMFCS Levels II and III

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)

Must not have

Not able to co-operate or be positioned adequately within the LOK as shown during the fitting/acclimatisation session

Orthopaedic surgery (soft tissue releases) within the last 9 months, or lower limb bony surgery within the last 18 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks, 20 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a walking training program using a robotic device is more effective than a regular physical therapy program or a combined robotic and physical therapy program for children with cerebral palsy.

Who is the study for?

This trial is for children and youth aged 5-18 with Cerebral Palsy, specifically those who can follow instructions for a walking test and participate in active physical therapy. They should be able to communicate discomfort and have certain levels of hip and knee flexibility. Participants must commit to multiple sessions over several weeks but cannot receive other mobility therapies during the study.

What is being tested?

The study tests four approaches: robotic device-assisted walking training (LOK), functional physical therapy (fPT) focusing on balance and motor skills, a combination of both LOK+fPT, and regular maintenance therapy. The goal is to see which method best improves walking-related motor skills over eight to ten weeks.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information; however, participants may experience fatigue or discomfort from increased physical activity during the interventions. Any specific side effects would likely relate to individual tolerance for exercise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have cerebral palsy and can walk with limitations.

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My hips and knees can move within the required range for the LOK.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot comfortably fit or stay in the required position for the treatment.

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I haven't had orthopaedic surgery in the past 9 months or bone surgery in my legs in the last 18 months.

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My hip is unstable, with more than 45% displacement.

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I have restrictions on activities that put weight on my legs.

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My knee is stiff and bends outward too much for a brace to fit.

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I have open skin wounds or blood vessel issues in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks, 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks, 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in gross motor abilities using the Gross Motor Function Measure (GMFM-66) from 0-8 and 0-20 weeks

Secondary study objectives

Change in individual goal attainment using the Canadian Occupational Performance Measure (COPM) performance ratings from 0-8 and 0-20 weeks

Change in self-efficacy for physical activity as measured by the Physical Activity Self-efficacy scale

Change in walking distance using the 6-Minute walk test from 0-8 and 0-20 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Lokomat (LOK)Experimental Treatment1 Intervention

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.

Group II: LOK + fPTExperimental Treatment1 Intervention

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.

Group III: Gait focused physical therapy (fPT)Experimental Treatment1 Intervention

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).

Group IV: Maintenance therapyActive Control1 Intervention

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.

0 / 8Eligibility criteria met