Use of Vibration During Constraint-induced Movement Therapy | NCT06452576

Studies
Use of Vibration During Constraint-induced Movement Therapy

NCT06452576

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Jul 7, 2025Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Hemiparesis

Interventions

Vibration
constraint-induced movement therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2024Actual

Primary Completion Date

Sep 9, 2024Actual

Completion Date

Sep 9, 2024Actual

First Submitted Date

Jun 4, 2024

First Submission Date that Met QC Criteria

Jun 10, 2024

First Posted Date

Jun 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2025

Last Update Posted Date

Jul 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Na Jin Seo, Professor-Faculty, Medical University of South CarolinaPrincipal Investigator

Lead Sponsor

Medical University of South CarolinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vibration	Device	Watch vibrates.	Wear vibrating watch during therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Na Jin Seo, PhD	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010291	Paresis

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000098483	Constraint Induced Movement Therapy

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D026741	Physical Therapy Modalities
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided