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Surface EMG Biofeedback for Children With Cerebral Palsy

This study is currently recruiting participants.
Verified August 2017 by Terence Sanger, University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681888
First Posted: September 10, 2012
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
  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: 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

Resource links provided by NLM:


Further study details as provided by Terence Sanger, University of Southern California:

Primary Outcome Measures:
  • Goal Attainment Scale [ Time Frame: 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.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surface EMG Biofeedback Device: Sanger EMG Biofeedback Device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01681888     History of Changes
Other Study ID Numbers: Biofeedback2012
First Submitted: July 19, 2012
First Posted: September 10, 2012
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Dystonia
Movement Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Dyskinesias