Surface EMG Biofeedback for Children With Cerebral Palsy

• Sponsor: University of Southern California (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01681888
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 92
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Dystonia; Hypertonia; Spasticity; Movement Disorders	Device: Sanger EMG Biofeedback Device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trial of Surface EMG Biofeedback for Children With Cerebral Palsy and Associated Movement Disorders
• Study Start Date: May 1, 2012
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surface EMG Biofeedback	Device: Sanger EMG Biofeedback Device

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Los Angeles	Los Angeles	California	United States	90027

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Terence Sanger, MD, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Terence Sanger, Associate Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT01681888
• Other Study ID Numbers: Biofeedback2012
• First Posted: Sep 10, 2012
• Last Update Posted: Sep 7, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Cerebral Palsy; Dystonia; Movement Disorders

Study Results

No Results Posted as of Sep 7, 2018