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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
Must not have
Skin lesions in areas where the device straps would be attached
Uncontrolled movements that prevent transfer in and/or out of device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am between 2 and 12 years old.
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I need assistance for most of my daily activities.
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I have been diagnosed with cerebral palsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have skin lesions where a medical device would be attached.
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I cannot control my movements well enough to get in or out of a device on my own.
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I have limitations on how much weight I can put on my legs.
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My knee cannot fully straighten, bending more than 20 degrees.
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I have seizures that are not controlled by medication.
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My knee bends inward more than 40 degrees.
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I have undergone serial casting within the last 3 months.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherance to protocol for each participant
Device tolerability
Enrollment and recruitment in this study design
+1 more
Secondary study objectives
2 minute walk test (2mwt)
Barry Albright Dystonia Scale
Edinburgh Visual Gait Score
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor
129 Previous Clinical Trials
60,445 Total Patients Enrolled
2 Trials studying Cerebral Palsy
2,111 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
~2 spots leftby Dec 2025
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