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Behavioural Intervention
Exoskeleton-Assisted Movement for Stroke
N/A
Recruiting
Led By Jose L Pons, Ph.D
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of a brain and/or skull lesion
Age from 18 to 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for experiment b, change between baseline and through participant completion, an average of 3 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether the decoder can control the exoskeleton in real-time based on HD-EMG recordings from the participant's muscles with the aim of providing functional assistance.
Who is the study for?
This trial is for adults aged 18-80 with normal movement in their limbs, no brain/skull lesions, correctable hearing and vision. It includes stroke survivors who had a unilateral, supratentorial stroke over 6 months ago without other neurological disorders.
What is being tested?
The study tests a new controller for exoskeletons that uses muscle signals to predict movements. Participants will perform various muscle contractions and activities while wearing an exoskeleton that's guided by this technology.
What are the potential side effects?
Since the intervention involves physical activity with an exoskeleton based on muscle signals, potential side effects may include muscle fatigue or discomfort from the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had a brain or skull lesion.
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I am between 18 and 80 years old.
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My hearing and vision are normal or corrected to normal.
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I do not have any conditions that cause unusual movements in my arms or legs.
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I do not have any neurological disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for experiment b, change between baseline and through participant completion, an average of 3 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for experiment b, change between baseline and through participant completion, an average of 3 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in 10WMT
Change in 6MWT
Change in Berg Balance Scale
+8 moreAwards & 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: Healthy ParticipantsExperimental Treatment5 Interventions
The investigators will look at muscle activity of healthy participants from eight lower limb muscles during functional tasks (e.g. single-joint movement, walking, squatting, cycling).
Group II: Clinical ParticipantsExperimental Treatment5 Interventions
The investigators will look at muscle activity of participants post-stroke from eight lower limb muscles during functional tasks (e.g. single-joint movement, walking, squatting, cycling).
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
17,925 Total Patients Enrolled
74 Trials studying Stroke
8,687 Patients Enrolled for Stroke
Jose L Pons, Ph.DPrincipal InvestigatorShirley Ryan AbilityLab
1 Previous Clinical Trials
1 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had a brain or skull lesion.I am between 18 and 80 years old.I had a stroke in the upper part of my brain more than 6 months ago.My hearing and vision are normal or corrected to normal.I do not have any conditions that cause unusual movements in my arms or legs.I do not have any neurological disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Participants
- Group 2: Clinical Participants
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.
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