Surface EMG Biofeedback for Children With Cerebral Palsy
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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 |
- Goal Attainment Scale [ 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 |
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| Contact: Aprille Tongol, B.A. | 213-740-1317 | tongol@usc.edu |
| Contact: Diana Ferman, P.A. | 310-425-2342 | dferman@usc.edu |
| 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 | |
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: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Movement Disorders Cerebral Palsy Dystonia Dystonic Disorders Muscle Hypertonia 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 May 16, 2013