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

Summary

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.

Conditions

• Cerebral Palsy

Interventions

PROCEDURE

Gait focused physical therapy (fPT)

Overground physical therapy focussed on enhancing gait related motor skills

PROCEDURE

LOK + fPT

A combination of robotic gait training and gait focussed functional physical therapy.

PROCEDURE

Lokomat (LOK)

Physical therapy provided using a robotic gait training system (Lokomat).

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital

  collaborator OTHER

• Shirley Ryan AbilityLab

  collaborator OTHER

• Northeastern University

  collaborator OTHER

• University of Alberta

  lead OTHER

Principal Investigators

• Virginia Wright, PhD · Holland Bloorview Kids Rehabilitation Hospital

• Lesley Wiart, PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• United States
• Canada

Study Locations