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Behavioural Intervention
Sensory Stimulation for Stroke Recovery
N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
WFMT hand task average time <120 s
18 years old or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks
Awards & highlights
Study Summary
This trial will test if adding vibration to hand task practice can help people with movement disabilities.
Who is the study for?
This trial is for adults over 18 who had a stroke at least 6 months ago and have difficulty with hand tasks. They must be able to follow instructions and not be on certain spasticity medications or undergoing other upper limb therapies. Severe spasticity, skin issues at the wrist, or other conditions affecting arm function disqualify them.Check my eligibility
What is being tested?
The study is testing if adding vibration to regular hand exercises helps improve hand function better than just doing the exercises alone after a stroke. Participants will either receive real vibration stimulation or no stimulation while practicing hand tasks.See study design
What are the potential side effects?
Since this trial involves non-invasive sensory stimulation and physical therapy, side effects are minimal but may include temporary discomfort or skin irritation from the vibration device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can complete hand tasks quickly, in less than 120 seconds.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Score of Wolf Motor Function Test (WMFT)
Secondary outcome measures
Change in Score of Action Research Arm Test
Change in Score of Box and Blocks Test
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: VibrationActive Control1 Intervention
The device will deliver imperceptible vibration for the treatment group.
Group II: No VibrationPlacebo Group1 Intervention
The device will deliver no vibration for the control group.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,559 Total Patients Enrolled
67 Trials studying Stroke
59,975 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,506 Total Patients Enrolled
79 Trials studying Stroke
5,311 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't changed my spasticity medication or had a botulinum toxin injection in my arm in the last 3 months.It has been over 6 months since my stroke.I am currently receiving therapy for my arm.I have a health condition that affects my arm's ability to move or feel.I can complete hand tasks quickly, in less than 120 seconds.My severe muscle stiffness hinders my ability to participate in physical therapy.I am 18 years old or older.Your average time to complete the Wolf Motor Function Test is more than 10 seconds.
Research Study Groups:
This trial has the following groups:- Group 1: Vibration
- Group 2: No Vibration
Awards:
This trial has 0 awards, including: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.
Are recruitment efforts still underway for this clinical study?
"Evidence on clinicaltrials.gov indicates that the recruitment process for this trial is in motion. The first posting of the study occurred on November 2nd 2020, with an edit having been made as recently as November 15th 2022."
Answered by AI
How many participants are enrolled in this investigation?
"Affirmative. According to clinicaltrials.gov, this research endeavour is actively recruiting patients with a post date of November 2nd 2020 and an edit on November 15th 2022. Currently they need 76 participants from one site."
Answered by AI
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