Use of Vibration During Constraint-induced Movement Therapy

NCT06452576 | Completed

• 1 other identifier: Pro00137672
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiparesis

Keywords

constraint-induced movement therapy

Outcome Measures

Primary Outcomes (1)

• Box and Block Test

  number of blocks moved in a minute

  pre-therapy and post-therapy, up to 5 consecutive days

Study Arms (2)

Wear vibrating watch during therapy

EXPERIMENTAL

The watch worn on the affected wrist vibrates during therapy.

Device: Vibration; Behavioral: constraint-induced movement therapy

Wear non-vibrating watch during therapy

PLACEBO COMPARATOR

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

Behavioral: constraint-induced movement therapy

Interventions

Vibration DEVICE

Watch vibrates.

Wear vibrating watch during therapy

constraint-induced movement therapy 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; Wear vibrating watch during therapy

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Developmental delays limiting spontaneous use of the affected upper limb
• Other health impairment

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Paresis

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Na Jin Seo, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: July 15, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: July 7, 2025

Record last verified: 2025-07

Locations

US (1)