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Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy

NCT04388787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-01-18

Study results available
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Summary

The purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

Stochastic resonance (SR) wraps

SR wraps will be applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators will be secured around the shoulder. The threshold for detection of SR will be determined by the examiner prior to initiating the test condition. The intensity of the stimulation is adjustable with a scroll bar on the app and ranges from a 0 - 100. The examiner will gradually increase the stimulus intensity until the participant reports being able to feel it. This will set the participant's detection threshold.

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-10
Primary Completion
2020-11-14
Completion
2020-11-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388787 on ClinicalTrials.gov