Use of Vibration During Constraint-induced Movement Therapy (CPT)

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.

Study Overview

• Status: Completed
• Conditions: Hemiparesis
• Intervention / Treatment: Device: Vibration; Behavioral: constraint-induced movement therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wear vibrating watch during therapy; The watch worn on the affected wrist vibrates during therapy.	Device: Vibration; Watch vibrates.; Behavioral: 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.
Placebo Comparator: Wear non-vibrating watch during therapy; The watch worn on the affected wrist does not vibrate during therapy.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block Test	number of blocks moved in a minute	pre-therapy and post-therapy, up to 5 consecutive days

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Na Jin Seo, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 7, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: constraint-induced movement therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Paresis
• Other Study ID Numbers: Pro00137672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No