Sensory Stimulation During CIMT

Cerebral Palsy Clinical Trial

Official title:

Sensory Stimulation During Constraint-Induced Movement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558230
• Other study ID #: PRO74164
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: October 28, 2018

Study information

• Verified date: November 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 28, 2018
• Est. primary completion date: October 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Standardized Constraint-Induced Movement Therapy
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.
• Vibration
Vibration applied to the wrist.
• Placebo (for vibration)
No vibration applied to the wrist.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (Total Number of Hours That Participants Wear the Device)	total number of hours that participants wear the device	through 5-day study completion.