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WithdrawnNCT01681888Updated Feb 26, 2024

Surface EMG Biofeedback for Children With Cerebral Palsy

An interventional study of Sanger EMG Biofeedback Device in Cerebral Palsy, Dystonia and Hypertonia, sponsored by University of Southern California. Withdrawn at 1 site in United States. Open to participants aged 0 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by University of Southern California · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The PI for this trial, which has been terminated, is no longer employed by USC. After repeated attempts of contact, we are unable to identify the PI's current employment. We would therefore request close out of this clinical trial record.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
0 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy
  • Dystonia
  • Hypertonia
  • Spasticity
  • Movement Disorders
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

Browse Cerebral Palsy studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 21 Years
Sexes eligible
All
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

Exclusion Criteria:

  • Unable to wear device for at least 5 hours day for a month.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Surface EMG Biofeedback

    Device: Sanger EMG Biofeedback Device

Interventions

  • DeviceSanger EMG Biofeedback Device
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two months

07

Study locations

1 site
  • Children's Hospital of Los Angeles
    Los Angeles, California 90027, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01681888
Lead sponsor
University of Southern California
Responsible party
Michelle Cullen (Research Compliance Manager, University of Southern California) — Principal investigator
First posted
Sep 10, 2012
Start date
May 2012
Primary completion
Feb 22, 2024
Completion
Feb 22, 2024
Last update
Feb 26, 2024

Study contacts

Terence Sanger, MD, PhD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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