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Haptic and Visual Feedback for Stroke
N/A
Waitlist Available
Led By Jose L Pons, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.
Awards & highlights
Study Summary
This trial will compare the effects of three different types of stroke rehabilitation therapies.
Eligible Conditions
- Stroke
- Spasticity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 10-meter walking test
Change in 6-minute walking test
Change in Functional Gait Assessment (FGA)
+8 moreSecondary outcome measures
Change in co-activation index of the muscles
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Visual FeedbackExperimental Treatment1 Intervention
The participants will be single-blinded and wear the M1 robotic device in transparency mode on their affected/weaker foot, and complete up to 30 minutes of training with visual biofeedback (games). The participants will complete 12 training sessions. The transparency mode of the robotic device compensates for its weight and friction so that the participant does not feel weight while moving the device.
Group II: Haptic and Visual FeedbackExperimental Treatment1 Intervention
The participants will be single-blinded and wear the M1 robotic device in assistance mode on their affected/weaker foot, and complete up to 30 minutes of training with visual biofeedback (games). The participants will complete 12 training sessions. The assistance mode of the robotic device applies assistive/resistive torque based on muscle activity.
Group III: Conventional robotic continuous passive movement trainingActive Control1 Intervention
The participants will be single-blinded and wear the M1 robotic device on their affected/weaker foot, and complete up to 30 minutes of continuous passive movement per training session. The participants will complete 12 training sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Visual Feedback
2016
N/A
~420
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,825 Total Patients Enrolled
69 Trials studying Stroke
6,285 Patients Enrolled for Stroke
Jose L Pons, PhDPrincipal InvestigatorShirley Ryan AbilityLab
5 Previous Clinical Trials
265 Total Patients Enrolled
4 Trials studying Stroke
260 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be between 18 and 80 years old to participate.You have normal hearing and vision, and if you wear corrective lenses, you are able to wear them during the study.You don't have any medical conditions that cause uncontrollable movements in your arms or legs such as epilepsy, stroke, or chronic pain.You must have muscles that are suitable for biofeedback training.You need to have muscles that are suitable for biofeedback.You must be able to bend your joint at least 15 degrees and straighten it at least 10 degrees.You do not have any neurological disorders.You understand the study and give permission to participate.You don't have any allergies to tape or adhesive material used in the study.You had a stroke in the upper part of your brain at least three months ago. You should have a minimum level of muscle strength in your leg and foot equivalent to a Manual Muscle Test (MMT) score of greater than or equal to +2.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional robotic continuous passive movement training
- Group 2: Visual Feedback
- Group 3: Haptic and Visual Feedback
Stroke Patient Testimony for trial: Trial Name: NCT05006248 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies within this research endeavor?
"According to clinicaltrials.gov, this trial is presently recruiting participants. This medical research first appeared on March 27th 2022 and was last revised on July 13th 2022."
Answered by AI
Is this trial open to senior citizens?
"Eligible participants for this medical trial must be above the age of consent and under 80 years old."
Answered by AI
Am I eligible to enroll in this experiment?
"This medical trial is seeking 60 individuals aged between 18 and 80 who have sustained a stroke. Furthermore, the participants must be able to correctly interpret information and provide informed consent; possess normal hearing/vision (correctable); demonstrate minimal muscular activation of +2 on Manual Muscle Test readings; lack any skin allergies to adhesive substances or pastes; not experience neurological disorders or additional pathologies that could lead to abnormal extremity movements (e.g., epilepsy, chronic pain); present with active flexion angles at 15 degrees minimum and 10 degree extension angles minimum; plus display appropriate muscle sites for biofeedback purposes."
Answered by AI
How many participants are contributing to this clinical experiment?
"Correct. Per information on clinicaltrials.gov, recruitment for this medical experiment is presently underway; it was first posted on March 27th 2022 and the latest update was issued July 13th 2022. 60 patients will be accepted at a single site."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have spastic quadreparesis and implanted baclofen pump.
PatientReceived 1 prior treatment
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