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Behavioural Intervention
CI Therapy for Stroke-related Arm Weakness
N/A
Recruiting
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 post stroke
The ability to demonstrate the minimum UE active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months following the end of the 2 weeks of treatment.
Awards & highlights
Study Summary
This trial looks at the effects of Constraint-Induced Therapy (CI Therapy) on people who have had a stroke.
Who is the study for?
This trial is for adults who had a stroke at least 6 months ago and have mild difficulty using their upper limb. They must be able to move their wrist and fingers to some extent and score above a certain level on an activity log. People with severe cognitive impairment, unable to consent, or can't attend treatment sessions are excluded.Check my eligibility
What is being tested?
The study tests Constraint-Induced Therapy (CI Therapy) which includes intensive motor training, behavioral strategies, and restraint of the less affected hand to improve use of the more-affected arm after a stroke.See study design
What are the potential side effects?
While not explicitly listed in the provided information, CI Therapy may lead to fatigue due to intense exercise, frustration or emotional distress from challenging tasks, skin irritation from restraints used on the less affected limb.
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 fingers as required.
Select...
I use my weaker arm or hand more than average.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at follow-up at 3 months following the end of treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at follow-up at 3 months following the end of treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
45-Item Motor Activity Log (MAL)
Canadian Occupational Performance Measure (COPM)
Wolf Motor Function Test (WMFT)
Secondary outcome measures
9 Hole Peg Test (9HPT)
Beck Depression Inventory (BDI)
Revised Nottingham Sensory Assessment (rNSA)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Grade 1 CI Therapy + Sensory ComponentsExperimental Treatment1 Intervention
All participants will receive the Grade 1 CI Therapy + Sensory Components administered over a two-week period of time.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,342 Total Patients Enrolled
36 Trials studying Stroke
87,372 Patients Enrolled for Stroke
David Morris, PhDStudy ChairUniversity of Alabama at Birmingham
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Stroke
12 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand or answer questions about my treatment.You score less than 24 on a test that checks your memory and thinking skills.I cannot go to the lab for treatment.It has been over 6 months since my stroke.I can move my wrist, thumb, and fingers as required.I use my weaker arm or hand more than average.
Research Study Groups:
This trial has the following groups:- Group 1: Grade 1 CI Therapy + Sensory Components
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.
Is this scientific exploration currently accepting participants?
"According to clinicaltrials.gov, this medical trial is not presently accepting enrolment applications. The study was first advertised on December 1st 2022 and its last update occurred November 29th 2022. Although the current project does not require additional patients at this time, there are a total of 1070 other trials actively searching for participants."
Answered by AI
What is the primary aim of this clinical experiment?
"This medical trial's main outcome of evaluation within a 2 week-long intervention period will be the 45-Item Motor Activity Log (MAL). Secondary outcomes include Stroke Impact Scale (SIS) which gauges quality of life and disability based on self-reporting, 9 Hole Peg Test (9HPT) that evaluates finger dexterity, and Semmes-Weinstein Monofilament Test (SWMT), a test to measure sensitivity."
Answered by AI
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