Sensory Stimulation During CIMT

NCT03558230 | Completed Results DMC

• 1 other identifier: PRO74164
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.

Conditions

Cerebral Palsy

Keywords

pediatric; hemiplegic; hand function

Outcome Measures

Primary Outcomes (1)

• Feasibility (Total Number of Hours That Participants Wear the Device)

  total number of hours that participants wear the device

  through 5-day study completion.

Study Arms (2)

Vibration

EXPERIMENTAL

The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.

Behavioral: Standardized Constraint-Induced Movement Therapy; Behavioral: Vibration

No Vibration

PLACEBO COMPARATOR

The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy. * The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.

Behavioral: Standardized Constraint-Induced Movement Therapy; Behavioral: Placebo (for vibration)

Interventions

Standardized Constraint-Induced Movement Therapy BEHAVIORAL

The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.

No Vibration; Vibration

Vibration BEHAVIORAL

Vibration applied to the wrist.

Vibration

Placebo (for vibration) BEHAVIORAL

No vibration applied to the wrist.

No Vibration

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

* Between the ages of 3 and 9 * Have unilateral upper limb motor weakness. * Use the affected extremity as a gross assist during play and self-care activities. * No significant developmental delays that would limit spontaneous use of the more affected extremity. * Be ambulatory for their age and demonstrate intact balance and protective reactions throughout the less involved upper extremity. * No other health impairment other than hemiparesis.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Vibration

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Results Point of Contact

• Title: Dr. Na Jin Seo
• Organization: Medical University of South Carolina

seon@musc.edu

843-792-0084

Study Officials

• Na Jin Seo, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blinded stratified randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 15, 2018
• Study Start: July 16, 2018
• Primary Completion: October 28, 2018
• Study Completion: October 28, 2018
• Last Updated: March 8, 2019
• Results First Posted: March 8, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)