Surface EMG Biofeedback for Children With Cerebral Palsy

Not Applicable

Withdrawn

• Conditions: Cerebral Palsy; Movement Disorders; Hypertonia; Dystonia; Spasticity
• Interventions: Device: Sanger EMG Biofeedback Device

• Registration Number: NCT01681888
• Lead Sponsor: University of Southern California

Brief Summary

Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent voluntary movement. Studies have suggested that using biofeedback to increase awareness of muscle activation can improve motor function in patients with motor deficits. The investigators hypothesize that the daily use of a surface electromyographic (SEMG) biofeedback device for one month will improve motor function in children and young adults with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the muscle(s) the subject has difficulty in controlling and provides vibratory feedback about muscle activation. Groups of children and young adults (ages 3-21), with dystonia, hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory feedback device on their affected muscle(s) for 5 hours a day for one month. The device will vibrate and emit a blue light when the muscle is activated. At the start of the experiment, subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one month, subjects will practice goals without device. After a month, subject will be assessed again and be given device to practice goals for a month. After one month, the subjects will be tested on the outcome measures again and return device.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-10
• Status Verified: 2024-02
• Primary Completion: 2024-02-22
• Study Completion: 2024-02-22
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Cerebral palsy, or associated movement disorders such as dystonia, spasticity, and/or hypertonia
• Able to wear device for given amount of time

Exclusion Criteria

• Unable to wear device for at least 5 hours day for a month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surface EMG Biofeedback	Sanger EMG Biofeedback Device	-

Primary Outcome Measures

Name	Time	Method
Goal Attainment Scale	Two months	The Goal Attainment Scale measures function in each of 5 areas that are individually chosen by the parents or adolescents at the initial visit. Parents and/or adolescents are encouraged to choose 2 basic movement goals and 3 goals related to function.

Trial Locations

Locations (1)

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States