Vibration + CIMT for Hemiparesis

(CPT Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Developmental delays, other health impairment

Compensation: Varies

Number of Visits: 5

Duration: 1 week

8 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Constraint-induced Movement Therapy and Vibration for hemiparesis?

Research shows that Constraint-Induced Movement Therapy (CIMT) can significantly improve motor function in people with hemiparesis (weakness on one side of the body) due to stroke or multiple sclerosis. Studies indicate that CIMT helps the brain reorganize and improve movement in the affected limb, with benefits lasting for years. ^{1 2 3 4 5}

Is Constraint-Induced Movement Therapy (CIMT) safe for humans?

Constraint-Induced Movement Therapy (CIMT) has been studied in various conditions like stroke, cerebral palsy, and multiple sclerosis, and is generally considered safe for humans. The studies do not report significant safety concerns, suggesting it is well-tolerated. ^{3 6 7 8 9}

How is the treatment Constraint-induced Movement Therapy (CIMT) for hemiparesis different from other treatments?

Constraint-induced Movement Therapy (CIMT) is unique because it involves restricting the use of the less affected arm to encourage the use of the more affected arm, promoting brain plasticity (the brain's ability to change and adapt) and improving function. This approach is different from other treatments that may not focus on intensive use of the affected limb or the concept of neuroplasticity. ^{3 4 5 10 11}

What is the purpose of this trial?

The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration.

Research Team

Na Jin Seo, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for individuals with unilateral upper limb motor weakness due to conditions like peripheral neuropathy or hemiparesis. Participants should be able to use their affected arm as an assist and walk appropriately for their age with good balance in the less affected arm.

Inclusion Criteria

I have weakness in one arm.

I can walk and have good balance and control in my less affected arm.

I can use my affected arm for basic tasks and play.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo constraint-induced movement therapy (CIMT) with or without vibration for up to 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Constraint-induced Movement Therapy
• Vibration

Trial Overview The study aims to see if adding low-level vibration to constraint-induced movement therapy (CIMT) improves hand function better than just CIMT alone. It's a comparison between two different ways of doing therapy for people with arm weakness.

Participant Groups

Group I: Wear vibrating watch during therapy Experimental Treatment 2 Interventions

The watch worn on the affected wrist vibrates during therapy.

Group II: Wear non-vibrating watch during therapy Placebo Group 1 Intervention

The watch worn on the affected wrist does not vibrate during therapy.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

A preliminary phase II trial with 20 adults showed that Constraint-Induced Movement Therapy (CIMT) significantly improved real-world use of the affected arm in patients with multiple sclerosis (MS), with an average increase of 2.7 points on the Motor Activity Log compared to only 0.5 points in the complementary and alternative medicine (CAM) group.

The benefits of CIMT were not only significant but also long-lasting, as improvements were maintained at a 1-year follow-up, and the therapy was well tolerated with no reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function. Mark, VW., Taub, E., Uswatte, G., et al.[2019]

Constraint-induced (CI) movement therapy significantly improves the use of the affected upper extremity in stroke patients by encouraging them to use their impaired arm for many hours each day over 10 to 14 days.

The therapy has shown lasting benefits, with increased arm use in daily activities persisting for up to 2 years, and patients who are likely to benefit can be identified prior to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Taub, E., Wolf, SL.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Revisiting constraint-induced movement therapy: are we too smitten with the mitten? Is all nonuse "learned"? and other quandaries. [2016]

2. Sweden pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy: bridging from the primate laboratory to the stroke rehabilitation laboratory. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Constraint-Induced Movement therapy can improve hemiparetic progressive multiple sclerosis. Preliminary findings. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of constraint-induced movement therapy on spasticity in patients with hemiparesis after stroke. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Pediatric constraint-induced movement therapy: a promising intervention for childhood hemiparesis. [2009]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Rehabilitation of stroke patients with plegic hands: Randomized controlled trial of expanded Constraint-Induced Movement therapy. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy after stroke. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Constraint-Induced Movement Therapy for Cerebral Palsy: A Randomized Trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The effects of constraint-induced therapy on precision grip: a preliminary study. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. [2016]