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Exoskeleton

Robotic Exoskeleton Therapy for Cerebral Palsy

N/A
Recruiting
Led By Max J Kurz, PhD
Research Sponsored by Father Flanagan's Boys' Home
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cerebral Palsy diagnosis for Cerebral Palsy participants
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (cp and neurotypical) and 8 weeks (cp)
Awards & highlights

Study Summary

This trial will compare the effects of traditional physical therapy versus a robotic exoskeleton on sensorimotor cortical activity, brain/spinal cord MRI imaging, neurophysiological tests, and mobility clinical tests in adolescents and young adults with cerebral palsy.

Who is the study for?
This trial is for adolescents and young adults with cerebral palsy who haven't had orthopedic surgery in the last 6 months or any metal in their body that would interfere with MRI scans. Participants should not have other neurodevelopmental conditions like autism, Down Syndrome, or ADHD.Check my eligibility
What is being tested?
The study compares traditional physical therapy to robotic exoskeleton gait training for improving walking abilities. Participants will undergo brain imaging, spinal cord tests, and mobility assessments before and after completing the gait training protocol.See study design
What are the potential side effects?
While specific side effects are not detailed here, participants may experience discomfort from physical exertion during therapy sessions or potential skin irritation from wearing the robotic exoskeleton.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Cerebral Palsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (cp and neurotypical) and 8 weeks (cp)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (cp and neurotypical) and 8 weeks (cp) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Brain Activity in Sensory Cortices
Change in Hoffmann Reflex
Change in Isolation of Movement
+6 more
Secondary outcome measures
Cognitive related changes induced via physical therapy - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire
Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)
Cognitive related changes induced via physical therapy - D2 - Test of Attention
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cerebral Palsy Youth/Young Adults Robotic ExoskeletonExperimental Treatment1 Intervention
Baseline and 8 week assessments; 8 week gait therapy using robotic exoskeleton
Group II: Cerebral Palsy Youth/Young Adults Physical TherapyActive Control1 Intervention
Baseline and 8 week assessments; 8 week gait therapy

Find a Location

Who is running the clinical trial?

Father Flanagan's Boys' HomeLead Sponsor
10 Previous Clinical Trials
1,064 Total Patients Enrolled
1 Trials studying Cerebral Palsy
120 Patients Enrolled for Cerebral Palsy
Max J Kurz, PhDPrincipal InvestigatorFather Flanagan's Boys' Home
3 Previous Clinical Trials
191 Total Patients Enrolled
2 Trials studying Cerebral Palsy
159 Patients Enrolled for Cerebral Palsy

Media Library

Robotic Exoskeleton Gait Therapy (Exoskeleton) Clinical Trial Eligibility Overview. Trial Name: NCT05158218 — N/A
Cerebral Palsy Research Study Groups: Cerebral Palsy Youth/Young Adults Physical Therapy, Cerebral Palsy Youth/Young Adults Robotic Exoskeleton
Cerebral Palsy Clinical Trial 2023: Robotic Exoskeleton Gait Therapy Highlights & Side Effects. Trial Name: NCT05158218 — N/A
Robotic Exoskeleton Gait Therapy (Exoskeleton) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05158218 — N/A
Cerebral Palsy Patient Testimony for trial: Trial Name: NCT05158218 — N/A

Frequently Asked Questions

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

Does this research only accept participants who are of legal age?

"In keeping with the trial's eligibility requirements, potential enrollees must be between 14 and 30 years of age."

Answered by AI

How many participants are eligible to join this medical experiment?

"Affirmative. Per the clinicaltrials.gov database, this study is currently in search of 64 patients to be enrolled at one trial site. It was originally posted on December 2nd 2021, with its latest edit being made that same day."

Answered by AI

Are there any vacancies remaining in this research endeavor?

"According to the clinicaltrials.gov database, this trial is actively recruiting study participants and has been since December 2nd 2021 when it was first posted and last updated."

Answered by AI

Is participation in this research still open to the public?

"This research is open to 64 individuals with cerebral palsy aged between 14 and 30, provided that they have no signs of atypical neurological development (e.g autism, Down syndrome, ADHD etc.)."

Answered by AI

What is the ultimate goal of this research endeavor?

"This medical trial aims to observe changes in the Hoffmann Reflex over approximately 8 weeks. Secondary objectives of this study include assessing cognitive alterations via physical therapy with usage of the Stroop Test (which evaluates a subject's ability to inhibit cognitive interference while processing stimuli), D2 - Attention Exam (evaluating selective and sustained attention plus visual scanning speed) and Wide Range Assessment of Memory & Learning."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Boys Town National Research Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I'd like to learn more about the use of robotic exoskeletons for my Cerebral Palsy.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Boys Town National Research Hospital: < 48 hours
Average response time
  • < 2 Days
~14 spots leftby Dec 2024