Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV

NCT ID: NCT05378243

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2024-07-31

Brief Summary

Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.

Detailed Description

Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.

The primary objective is to assess feasibility of the study design and device tolerability. Specifically:

• Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached.
• Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments).
• Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups).
• Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation.

Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Robotic Gait Training

8 weeks of therapy with the robotic gait training device 4-5 times a week for 1 hour each session

Group Type: EXPERIMENTAL

Robotic Gait Training

Intervention Type: DEVICE

Use of a walker adapted with robotic components to promote proper walking gait

Functional Clinical Therapy

8 weeks of therapy with a custom designed therapy program for the participant's needs 4-5 times a week for 1 hour each session

Group Type: EXPERIMENTAL

Functional Clinical Therapy

Intervention Type: BEHAVIORAL

Personalized program of physical therapy targeted to improving walking gait

Interventions

Robotic Gait Training

Use of a walker adapted with robotic components to promote proper walking gait

Intervention Type: DEVICE

Functional Clinical Therapy

Personalized program of physical therapy targeted to improving walking gait

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of cerebral palsy
• GMFCS Levels III and IV
• Ages ≥2 to ≤12 years
• Ability to take steps with and/or without assistance
• Meet the Trexo Plus device size requirements
• Ability to follow instructions and signal pain, fear, or discomfort
• Ability to safely use the device at home as determined by the study team

Exclusion Criteria

• Lower limb or orthopedic surgery within 9 months prior to enrollment
• Botulinum toxin injections within 4 months prior to enrollment
• Serial casting within 3 months prior to enrollment
• Knee flexion contracture > 20°
• Knee valgus > 40°
• Hip subluxation > 40 % migration percentage
• Uncontrolled movements that prevent transfer in and/or out of device
• Weight bearing restrictions
• Uncontrolled seizures
• Skin lesions in areas where the device straps would be attached
• Significant language barrier with parents and/or caregivers Note: children with severe contractures will be unable to fit in the device and are therefore excluded from the study

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Brain Institute

OTHER

Sponsor Role: collaborator

Academic Health Science Centres

OTHER

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Anna McCormick

Pediatrician / Physical Medicine and Rehabilitation Specialist, Division Chief Developmental Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Michelle Larin

Role: CONTACT

MLarin@cheo.on.ca

6137377600 ext. 4359

Facility Contacts

Anna M McCormick, MD

Role: primary

amccormick@cheo.on.ca

613-737-7600 ext. 2831

Michelle Larin, MSc

Role: backup

MLarin@cheo.on.ca

613-737-7600 ext. 4359

Other Identifiers

20200502

Identifier Type: -

Identifier Source: org_study_id