What side effects are associated with this type of intervention?

Constraint-Induced (CI) Therapy for stroke rehabilitation, which includes intensive motor training, behavioral strategies, and the Transfer Package, is generally well-tolerated but can have some side effects. Intensive motor training may lead to muscle soreness, fatigue, and, in some cases, overuse injuries. Behavioral strategies and the Transfer Package, which aim to improve the use of the affected limb, can sometimes cause frustration or emotional stress due to the challenging nature of the tasks. However, these side effects are typically mild and manageable under professional supervision.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly mirror the Constraint-Induced (CI) Therapy approach for stroke, which includes intensive motor training, behavioral strategies, and a Transfer Package. However, stroke rehabilitation often involves a combination of physical therapy, occupational therapy, and sometimes speech therapy to improve motor function and daily living skills. These therapies aim to enhance neuroplasticity and functional recovery, similar to the goals of CI Therapy. Medications such as anticoagulants, antiplatelets, and thrombolytics are also commonly used to manage stroke and prevent recurrence.

What other types of research exist?

Promising novel alternatives to Constraint-Induced (CI) Therapy for stroke patients include: 1) Non-invasive neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), which have shown potential in enhancing motor recovery. 2) Virtual reality (VR)-based rehabilitation, which provides an engaging and immersive environment for motor training. 3) Robotics-assisted therapy, which uses robotic devices to facilitate repetitive, high-intensity motor practice. 4) Mirror therapy, which involves using a mirror to create a visual illusion of movement in the affected limb, thereby promoting motor recovery. These alternatives have demonstrated efficacy in improving motor function and promoting brain plasticity in stroke patients.

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Behavioural Intervention

CI Therapy for Stroke-related Arm Weakness

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

Summary

This trial tests a modified therapy for stroke patients with arm difficulties. The therapy involves intensive practice and strategies to use the affected arm more. The study aims to see if shorter, less frequent sessions are as effective as longer sessions. This type of therapy has been shown to improve motor function in stroke patients by encouraging the use of the affected arm.

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.

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.

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

Select...

It has been over 6 months since my stroke.

Select...

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:

Select...

I am unable to understand or answer questions about my treatment.

Select...

My mental state score is below 24.

Select...

I cannot come to the clinic for sessions.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Canadian Occupational Performance Measure (COPM)

Motor Activity Log (MAL)

Wolf Motor Function Test (WMFT)

Secondary study objectives

Stroke Impact Scale (SIS)

Zung Self-Rating Depression Scale

Awards & 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: 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

0 / 5Eligibility criteria met

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.