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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
Must not have
Inability to answer the MAL questions and/or provide informed consent
Score <24 on the Mini-Mental State Examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after the end of the treatment.
Awards & highlights

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 below
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It has been over 6 months since my stroke.
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I can move my wrist, thumb, and two fingers at least a little bit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or answer questions about my treatment.
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My mental state score is below 24.
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I cannot come to the clinic for sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after the end of the treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after the end of the treatment. for reporting.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Constraint-Induced (CI) Therapy for stroke patients involves intensive motor training, behavioral strategies, and a Transfer Package to improve the use of the more-affected limb. Intensive motor training, often through repetitive task practice, helps to strengthen neural pathways and improve motor function. Behavioral strategies encourage patients to use their affected limb more frequently in daily activities, which can lead to better functional outcomes. The Transfer Package includes techniques to remind and motivate patients to use their affected limb outside of therapy sessions, promoting continuous improvement. These components collectively facilitate brain plasticity and remodeling, which are crucial for recovery and regaining independence in daily life.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,910 Total Patients Enrolled
36 Trials studying Stroke
86,775 Patients Enrolled for Stroke

Media Library

Keys Constraint-induced Movement Therapy protocol (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05311384 — N/A
Stroke Research Study Groups: Keys intervention
Stroke Clinical Trial 2023: Keys Constraint-induced Movement Therapy protocol Highlights & Side Effects. Trial Name: NCT05311384 — N/A
Keys Constraint-induced Movement Therapy protocol (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05311384 — N/A
~3 spots leftby Jul 2025