Robotic Exoskeleton Gait Therapy for Cerebral Palsy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Boys Town National Research Hospital, Boys Town, NECerebral PalsyRobotic Exoskeleton Gait Therapy - Behavioral
Eligibility
14 - 30
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Cerebral Palsy

Treatment Effectiveness

Study Objectives

9 Primary · 11 Secondary · Reporting Duration: Baseline (CP and Neurotypical) and 8 weeks (CP)

Week 8
Change in Brain Activity in Sensory Cortices
Change in Hoffmann Reflex
Change in Isolation of Movement
Change in Level of Spasticity
Change in Mobility Test Time
Change in Motor Response
Change in Selective Control Assessment of the Lower Extremity
Change in Time for "Timed Up and Go"
Change in Time for Community Ambulation
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
Cognitive related changes induced via physical therapy - MacArthur Scale of Subjective Social Status Youth + Adult
Cognitive related changes induced via physical therapy - PEDS QL Fatigue Questionnaire (Acute)
Cognitive related changes induced via physical therapy - Pittsburgh Sleep Quality Index (PSQI)
Cognitive related changes induced via physical therapy - Silver Linings Questionnaire - Adapted for CP
Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult
Cognitive related changes induced via physical therapy - Trail Making A+B
Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult
Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)

Trial Safety

Trial Design

2 Treatment Groups

Cerebral Palsy Youth/Young Adults Physical Therapy
1 of 2
Cerebral Palsy Youth/Young Adults Robotic Exoskeleton
1 of 2

Active Control

Experimental Treatment

64 Total Participants · 2 Treatment Groups

Primary Treatment: Robotic Exoskeleton Gait Therapy · No Placebo Group · N/A

Cerebral Palsy Youth/Young Adults Robotic Exoskeleton
Behavioral
Experimental Group · 1 Intervention: Robotic Exoskeleton Gait Therapy · Intervention Types: Behavioral
Cerebral Palsy Youth/Young Adults Physical Therapy
Behavioral
ActiveComparator Group · 1 Intervention: Physical Therapy · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (cp and neurotypical) and 8 weeks (cp)

Who is running the clinical trial?

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

Eligibility Criteria

Age 14 - 30 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A cerebral palsy diagnosis can be very overwhelming
You do not have any known developmental disorders such as autism, Down Syndrome, or ADHD.

Who else is applying?

What state do they live in?
Virginia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Boys Town National Research Hospital100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
Why did patients apply to this trial?
  • "I'd like to learn more about the use of robotic exoskeletons for my Cerebral Palsy"
How many prior treatments have patients received?
3+100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 2 Days
Most responsive sites:
  1. Boys Town National Research Hospital: < 48 hours

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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.)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.