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Surface EMG Biofeedback for Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01681888
Recruitment Status : Unknown
Verified September 2018 by Terence Sanger, University of Southern California.
Recruitment status was:  Recruiting
First Posted : September 10, 2012
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Terence Sanger, University of Southern California

Tracking Information
First Submitted Date  ICMJE July 19, 2012
First Posted Date  ICMJE September 10, 2012
Last Update Posted Date September 7, 2018
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
Goal Attainment Scale
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surface EMG Biofeedback for Children With Cerebral Palsy
Official Title  ICMJE Clinical Trial of Surface EMG Biofeedback for Children With Cerebral Palsy and Associated Movement Disorders
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebral Palsy
  • Dystonia
  • Hypertonia
  • Spasticity
  • Movement Disorders
Intervention  ICMJE Device: Sanger EMG Biofeedback Device
Study Arms  ICMJE Experimental: Surface EMG Biofeedback
Intervention: Device: Sanger EMG Biofeedback Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681888
Other Study ID Numbers  ICMJE Biofeedback2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Terence Sanger, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terence Sanger, MD, PhD University of Southern California
PRS Account University of Southern California
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP