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Behavioural Intervention
CI Therapy for Stroke-related Arm Weakness
N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 6 months after stroke
Ability to demonstrate minimum movement criteria of more-affected UE including 10 degrees of wrist extension (starting from a fully flexed position), 10 degrees of thumb abduction, and 10 degrees of extension of two additional fingers at all joints
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after the end of the treatment.
Awards & highlights
Study Summary
This trial will explore whether a condensed version of CI therapy can be just as effective as the original protocol while being more time/resource friendly.
Who is the study for?
This trial is for stroke survivors who've had a stroke at least 6 months ago and have significant weakness in one arm. They must be able to move their wrist, thumb, and fingers just a little bit and can't have severe cognitive impairments or be unable to consent.Check my eligibility
What is being tested?
The study tests a modified Constraint-Induced Movement Therapy (CI therapy) protocol that fits insurance policies better by reducing therapist time. It involves intensive training, behavioral strategies, and restraint of the stronger arm to improve use of the weaker arm.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include muscle fatigue, discomfort from restraining the stronger limb, frustration or emotional distress due to intensive practice requirements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
It has been over 6 months since my stroke.
Select...
I can move my wrist, thumb, and two fingers at least a little bit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after the end of the treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after the end of the treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Canadian Occupational Performance Measure (COPM)
Motor Activity Log (MAL)
Wolf Motor Function Test (WMFT)
Secondary outcome measures
Stroke Impact Scale (SIS)
Zung Self-Rating Depression Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Keys interventionExperimental Treatment1 Intervention
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Keys Constraint-induced Movement Therapy protocol
2022
N/A
~10
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,278,019 Total Patients Enrolled
36 Trials studying Stroke
87,374 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the MAL shows that you have significant difficulties using your more affected arm.I can move my wrist, thumb, and two fingers at least a little bit.My mental state score is below 24.It has been over 6 months since my stroke.I am unable to understand or answer questions about my treatment.I cannot come to the clinic for sessions.
Research Study Groups:
This trial has the following groups:- Group 1: Keys intervention
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.
What is the upper limit to the number of people who can join this research project?
"That is correct, a quick glance at the information provided on clinicaltrials.gov reveals that this trial is still recruiting patients. The first posting was on 4/20/2022 and the most recent update was on 5/6/2022. Presently, the trial needs 16 patients from 1 locations."
Answered by AI
Who else is applying?
What state do they live in?
Maine
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- University of Alabama at Birmingham: < 24 hours
Average response time
- < 2 Days
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