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Behavioural Intervention
CI Therapy for Stroke-related Arm Weakness
Birmingham, AL
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.
Must not have
Inability to answer the MAL questions and/or provide informed consent
The inability to come in to the laboratory setting for treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at follow-up at 3 months following the end of treatment.
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at the effects of Constraint-Induced Therapy (CI Therapy) on people who have had a stroke.
See full description
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.
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I can move my wrist, thumb, and fingers as required.
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Select...
I use my weaker arm or hand more than average.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand or answer questions about my treatment.
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Select...
I cannot go to the lab for treatment.
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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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
45-Item Motor Activity Log (MAL)
Canadian Occupational Performance Measure (COPM)
Wolf Motor Function Test (WMFT)
Secondary study objectives
9 Hole Peg Test (9HPT)
Beck Depression Inventory (BDI)
Revised Nottingham Sensory Assessment (rNSA)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Find a Location
Closest Location:University of Alabama at Birmingham· Birmingham, AL· 494 miles
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,673 Previous Clinical Trials
2,457,195 Total Patients Enrolled
36 Trials studying Stroke
86,735 Patients Enrolled for Stroke
David Morris, PhDStudy ChairUniversity of Alabama at Birmingham
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Stroke
15 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.