Surface EMG Biofeedback for Children With Cerebral Palsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
ClinicalTrials.gov Identifier:
NCT01681888
First received: July 19, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention
Cerebral Palsy
Dystonia
Hypertonia
Spasticity
Movement Disorders
Device: Sanger EMG Biofeedback Device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of Surface EMG Biofeedback for Children With Cerebral Palsy and Associated Movement Disorders

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Goal Attainment Scale [ Time Frame: Two months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surface EMG Biofeedback Device: Sanger EMG Biofeedback Device

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681888

Contacts
Contact: Aprille Tongol, B.A. 213-740-1317 tongol@usc.edu
Contact: Diana Ferman, P.A. 310-425-2342 dferman@usc.edu

Locations
United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Aprille Tongol, B.A.    213-740-1317    tongol@usc.edu   
Contact: Diana Ferman, P.A.    310-425-2342    dferman@usc.edu   
Principal Investigator: Terence Sanger, MD, PhD         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Terence Sanger, MD, PhD University of Southern California
  More Information

No publications provided

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01681888     History of Changes
Other Study ID Numbers: Biofeedback2012
Study First Received: July 19, 2012
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscle Hypertonia
Cerebral Palsy
Dystonia
Dystonic Disorders
Movement Disorders
Muscle Spasticity
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Neuromuscular Manifestations
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014