NCT01681888|Withdrawn

Study Stopped

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.

Surface EMG Biofeedback for Children With Cerebral Palsy

Clinical Trial of Surface EMG Biofeedback for Children With Cerebral Palsy and Associated Movement Disorders

University of Southern California ClinicalTrials.gov

Compare

1 other identifier

Biofeedback2012

Study Type

interventional

Target

N/A

Locations

1 country

Sites

Timeline

RegisteredSep 2012

StartedMay 2012

CompletionFeb 2024

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11.8 years study duration

Study Start

First participant enrolled

May 1, 2012

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed

2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed

11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2024

Completed

Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

11.8 years

First QC Date

July 19, 2012

Last Update Submit

February 22, 2024

Conditions

Cerebral Palsy Dystonia Hypertonia Spasticity Movement Disorders

Outcome Measures

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.
Two months

Study Arms (1)