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Robotic Ankle Assistance + Audiovisual Biofeedback for Cerebral Palsy
N/A
Recruiting
Led By Katherine M Steele, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 1-month after intervention.
Awards & highlights
Study Summary
This trial aims to investigate how children with CP adapt their walking and see if treatments can improve it. A wearable exoskeleton and audio/visual cues will be used to measure and assess progress.
Who is the study for?
This trial is for children with bilateral cerebral palsy affecting both legs, who can walk but have some limitations (GMFCS Level II). They shouldn't have had leg surgery or injuries in the last year, botulinum toxin injections in the past 3 months, prior selective dorsal rhizotomy surgery, seizures or heart conditions that limit treadmill use, or current pain impacting walking.Check my eligibility
What is being tested?
The study tests how a wearable exoskeleton called Biomotum Spark and audiovisual biofeedback affect walking function. It involves adjusting treadmill speeds and providing real-time feedback to help children with CP learn new ways of moving and improve their walking ability through repeated training sessions.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the exoskeleton device, fatigue due to exercise on a treadmill with resistance at the ankle provided by the device, and possible frustration or stress from adapting to audiovisual biofeedback during movement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 1-month after intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 1-month after intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Dynamic Motor Control During Walking (Walk-DMC)
Change in Gait Deviation Index (GDI)
Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Sensorimotor BiofeedbackExperimental Treatment1 Intervention
Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving sensorimotor biofeedback with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait.
Group II: Audiovisual BiofeedbackExperimental Treatment1 Intervention
Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving audiovisual biofeedback based on the muscle activity of their ankle plantarflexors. The visual feedback will be provided on a screen with a bar showing real-time muscle activity and the audio feedback will be a sound played when they reach the target level of muscle activity.
Group III: Audiovisual + Sensorimotor BiofeedbackExperimental Treatment2 Interventions
Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving both audiovisual and sensorimotor biofeedback. Sensorimotor biofeedback will be provided with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait. The visual feedback will be provided on a screen with a bar showing real-time muscle activity and the audio feedback will be a sound played when they reach the target level of muscle activity from the plantarflexors.
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Who is running the clinical trial?
Gillette Children'sUNKNOWN
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,553 Total Patients Enrolled
10 Trials studying Cerebral Palsy
2,978 Patients Enrolled for Cerebral Palsy
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,730 Total Patients Enrolled
10 Trials studying Cerebral Palsy
1,168 Patients Enrolled for Cerebral Palsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cerebral palsy affecting both of my legs.I can walk but have some limitations in more advanced motor skills.I haven't had any botulinum toxin injections in the last 3 months.I don't have pain that stops me from walking.I haven't had surgery or injuries to my legs in the last year.I have not had selective dorsal rhizotomy surgery.I have no seizures or heart conditions that stop me from walking on a treadmill for 20 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: Audiovisual Biofeedback
- Group 2: Sensorimotor Biofeedback
- Group 3: Audiovisual + Sensorimotor Biofeedback
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation permit those aged 70 and above to participate?
"This clinical trial requires that applicants are aged 7-18. Across the United States, 169 trials for minors have been listed and 28 studies exist specifically for elderly individuals over 65."
Answered by AI
What criteria are necessary for individuals to qualify for enrolment in this experiment?
"Candidates that meet the qualifications, including having cerebral palsy and being between 7-18 years old, can participate in this trial. They are currently looking to recruit a total of 36 participants."
Answered by AI
Are there any vacancies in this clinical research for individuals to participate?
"Per clinicaltrials.gov's records, this particular medical trial is not taking in new patients at the moment. Initially posted on July 1st 2023 and last edited June 1st 2023, it currently cannot accept participants; however, 184 alternate studies are actively recruiting subjects."
Answered by AI
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