Surface EMG Biofeedback for Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Dystonia, Hypertonia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sanger EMG Biofeedback Device
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
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.
Sites / Locations
- Children's Hospital of Los AngelesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surface EMG Biofeedback
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01681888
First Posted
July 19, 2012
Last Updated
September 6, 2018
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT01681888
Brief Title
Surface EMG Biofeedback for Children With Cerebral Palsy
Official Title
Clinical Trial of Surface EMG Biofeedback for Children With Cerebral Palsy and Associated Movement Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Dystonia, Hypertonia, Spasticity, Movement Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surface EMG Biofeedback
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sanger EMG Biofeedback Device
Primary Outcome Measure Information:
Title
Goal Attainment Scale
Description
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.
Time Frame
Two months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aprille Tongol, B.A.
Phone
213-740-1317
Email
tongol@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Ferman, P.A.
Phone
310-425-2342
Email
dferman@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence Sanger, MD, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aprille Tongol, B.A.
Phone
213-740-1317
Email
tongol@usc.edu
First Name & Middle Initial & Last Name & Degree
Diana Ferman, P.A.
Phone
310-425-2342
Email
dferman@usc.edu
First Name & Middle Initial & Last Name & Degree
Terence Sanger, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Surface EMG Biofeedback for Children With Cerebral Palsy
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