Surface EMG Biofeedback for Children With Cerebral Palsy

NCT ID: NCT01681888

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2024-02-22

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.

Conditions

Cerebral Palsy; Dystonia; Hypertonia; Spasticity; Movement Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surface EMG Biofeedback

Group Type: EXPERIMENTAL

Sanger EMG Biofeedback Device

Intervention Type: DEVICE

Interventions

Sanger EMG Biofeedback Device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Michelle Cullen

Research Compliance Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terence Sanger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Children's Hospital of Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

Biofeedback2012

Identifier Type: -

Identifier Source: org_study_id