← Back to Search

Robotic Gait Training for Cerebral Palsy

N/A

Recruiting

Research Sponsored by Children's Hospital of Eastern Ontario

Eligibility Criteria Checklist

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

Must have

Ages ≥2 to ≤12 years

GMFCS Levels III and IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial is comparing the effects of two different types of therapy on subjects with mixed quantitative and qualitative methodology.

Who is the study for?

This trial is for children aged 2 to 12 with cerebral palsy (GMFCS Levels III and IV) who can fit into a Trexo Plus device, follow instructions, and use the device safely at home. Children with severe language barriers, recent botulinum toxin injections or surgeries, significant knee valgus or contractures, uncontrolled movements or seizures, skin lesions where the device straps go are excluded.Check my eligibility

What is being tested?

The study compares robotic gait training (RGT) with functional clinical therapy (FCT) in children with cerebral palsy using a randomized cross-over design. Each child serves as their own control to see which method better enables walking.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing the device straps or during transfer in/out of the robotic trainer. There might also be fatigue due to exercise and possible skin irritation under strap areas.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 2 and 12 years old.

Select...

I need assistance for most of my daily activities.

Select...

I have been diagnosed with cerebral palsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherance to protocol for each participant

Device tolerability

Enrollment and recruitment in this study design

+1 more

Secondary outcome measures

2 minute walk test (2mwt)

Barry Albright Dystonia Scale

Edinburgh Visual Gait Score

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Robotic Gait TrainingExperimental Treatment1 Intervention

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

Group II: Functional Clinical TherapyExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor

126 Previous Clinical Trials

55,472 Total Patients Enrolled

1 Trials studying Cerebral Palsy

111 Patients Enrolled for Cerebral Palsy

Ontario Brain InstituteOTHER

11 Previous Clinical Trials

3,019 Total Patients Enrolled

1 Trials studying Cerebral Palsy

4 Patients Enrolled for Cerebral Palsy

Academic Health Science CentresOTHER

7 Previous Clinical Trials

2,827 Total Patients Enrolled

Media Library

Functional Clinical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05378243 — N/A

Cerebral Palsy Research Study Groups: Robotic Gait Training, Functional Clinical Therapy

Cerebral Palsy Clinical Trial 2023: Functional Clinical Therapy Highlights & Side Effects. Trial Name: NCT05378243 — N/A

Functional Clinical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05378243 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this clinical research effort?

"Affirmative. Based on the info accessible on clinicaltrials.gov, this medical trial is still recruiting subjects; it was at first posted in November 8th 2021 and updated as recently as May 12th 2022. The research requires 10 participants from 1 location to proceed."

Answered by AI

What positive developments are being sought by this trial?

"The main metric evaluated over a period of four months is retention in the trial. Secondary assessments include Edinburgh Visual Gait Score which grades body positioning and angles during gait on a 0-2 scale, Physiological Cost Index which measures heart rate changes related to exertion, and Spinal Alignment and Range of Motion Measure that gauges range of motion from zero (no limitation) to four (severe limitation)."

Answered by AI

Is enrollment currently available for this healthcare experiment?

"According to clinicaltrials.gov, this trial is still open for recruitment and the postings have been updated as recently as May 12th 2022 since its original posting on November 8th 2021."

Answered by AI

Is participation in this experimental program limited to individuals under the age of 75?

"Per the parameters of this medical trial, children aged between 2 and 12 are eligible for enrollment."

Answered by AI

What qualifications must a participant possess in order to take part in this clinical trial?

"This clinical trial is seeking 10 participants with cerebral palsy between the ages of 2 and 12 years old. Eligibility includes a diagnosis of cerebral palsy at GMFCS Levels III or IV, as well as the capacity to take steps independently or with assistance, meet Trexo Plus device size criteria, understand instructions while expressing pain, fear, or discomfort when necessary; plus be able to safely utilize the device in a home setting under oversight from study personnel."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Anna McCormick 2021. "Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378243.

All > Cerebral Palsy