Use of Vibration During Constraint-induced Movement Therapy

NCT ID: NCT06452576

Last Updated: 2025-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2024-09-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The low-level vibration has been shown to increase therapy outcome when used as an adjunct to therapy in adults with hemiparesis. Children who participates in the CIMT camp at MUSC will be recruited to take part in the study. Participating children will wear a watch device on their weaker arm during CIMT. The watch will vibrate only for the children who were assigned to the treatment group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemiparesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wear vibrating watch during therapy

The watch worn on the affected wrist vibrates during therapy.

Group Type EXPERIMENTAL

Vibration

Intervention Type DEVICE

Watch vibrates.

constraint-induced movement therapy

Intervention Type BEHAVIORAL

A splint or mitt is placed on the stronger, unaffected hand to encourage use of the affected upper limb in therapy.

Wear non-vibrating watch during therapy

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

Group Type PLACEBO_COMPARATOR

constraint-induced movement therapy

Intervention Type BEHAVIORAL

A splint or mitt is placed on the stronger, unaffected hand to encourage use of the affected upper limb in therapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vibration

Watch vibrates.

Intervention Type DEVICE

constraint-induced movement therapy

A splint or mitt is placed on the stronger, unaffected hand to encourage use of the affected upper limb in therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Unilateral upper limb motor weakness
* Can use the affected upper limb as a gross assist during play and self-care activities
* Ambulatory for their age with intact balance and protective reactions in the less involved upper limb.

Exclusion Criteria

* Developmental delays limiting spontaneous use of the affected upper limb
* Other health impairment
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Na Jin Seo

Professor-Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Na Jin Seo, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00137672

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CIMT and taVNS for Hemiplegia in Infants
NCT05101707 COMPLETED EARLY_PHASE1