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Surface EMG Biofeedback for Children With Cerebral Palsy

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01681888
Enrollment
0
Registered
2012-09-10
Start date
2012-05-31
Completion date
2024-02-22
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Dystonia, Hypertonia, Movement Disorders, Spasticity

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.

Interventions

DEVICESanger EMG Biofeedback Device

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 21 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Goal Attainment ScaleTwo monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026