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

NCT ID: NCT04388787

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-10
• Study Completion Date: 2020-11-14

Brief 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.

Detailed Description

Vibration devices have been used by some patients with cerebral palsy during therapy sessions. Researchers believe they have the potential to be even more useful for everyday use, and are doing this study to learn more about what they can do.

Participate in this study will be asked to complete assessments that test arm motion, muscle tone, motor control, and sensory function. They will then be asked to wear a wristband on each wrist and on their shoulder. These wristbands contain vibrators that can vibrate at different levels. The vibrations are caused by a low-level of sound waves that people may barely be able to hear. While wearing the vibration devices on the wrist and shoulder, participants will be asked to perform two tasks. The first task is called the box and blocks test, which consists of transferring wooden blocks from one box to another. The second test is called the Shriners upper extremity evaluation (SHUEE). In this test participants will perform a series of fine motor tasks with their hands. The SHUEE test will be video recorded for scoring by a study therapist at a later time on how much and how well participants use their impaired arm to perform the tasks. Participants will be asked to complete the box and blocks test and the SHUEE test 3 times. Participation in this study will be one single visit and last approximately an hour to an hour and a half.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

stochastic resonance (SR) vibration

SR applied sub threshold at 90% of participant's detection threshold

Group Type: EXPERIMENTAL

Stochastic resonance (SR) wraps

Intervention Type: DEVICE

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.

Sham treatment

SR devices worn but not turned on (0% of participant's detection threshold).

Group Type: SHAM_COMPARATOR

Stochastic resonance (SR) wraps

Intervention Type: DEVICE

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.

Unblinded treatment

SR is applied above participant's detection threshold at a participant selected intensity.

Group Type: EXPERIMENTAL

Stochastic resonance (SR) wraps

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with cerebral palsy
• 3 years to 18 years of age
• Able to reliably express pain, discomfort or fear as reported by the parent/guardian
• Manual ability classification scale (MACS) levels I, II or III

Exclusion Criteria

• Any unstable medical condition. An unstable medical condition is a state of imminent threat to life such as shock, acute asthma, respiratory distress, severe infection and sepsis. Any patient in a clinic or therapy center presenting with signs and symptoms of an unstable medical condition will be directed to emergency medical services
• Any medical condition preventing active rehabilitation reported by the parent/guardian such as:

o Thromboembolic disease, acute progressive neurological disorder, cardiovascular or pulmonary contraindications, aggressive behavior, severe cognitive deficits, joint instabilities and compromised bone health, recent or non-consolidated fractures, osteoporosis

• Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices
• Skin lesions affecting the areas where the device straps will be attached to the body

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HM20018459

Identifier Type: -

Identifier Source: org_study_id