Surface EMG Biofeedback for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01681888
• Other study ID #: Biofeedback2012
• Status: Withdrawn
• Phase: N/A
• Start date: May 2012
• Est. completion date: February 22, 2024

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Sanger EMG Biofeedback Device

Locations

Country	Name	City	State
United States	Children's Hospital of Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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