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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Stochastic resonance (SR) wraps

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stochastic resonance (SR) vibration; SR applied sub threshold at 90% of participant's detection threshold	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.
Sham Comparator: Sham treatment; SR devices worn but not turned on (0% of participant's detection threshold).	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.
Experimental: Unblinded treatment; SR is applied above participant's detection threshold at a participant selected intensity.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Manual Dexterity	Manual dexterity is will be assessed using the Box and Block (B&B) test. The B&B test is scored by counting the number of blocks transferred during the 1 minute test. Higher scores indicate better manual dexterity. Change was assessed after each condition and compared to baseline.	Baseline to up to 1.5 hours
Change in Upper Extremity Functionality	Upper extremity functionality will be assessed using the Shriners Upper Extremity Evaluation (SHUEE). Participants are observed and scored by a trained rater blind to the condition. Scores range from 0 to 45 for spontaneous functional activity and from 0 to 72 for dynamic positional analysis. Higher scores indicate better functionality.	Baseline to up to 1.5 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): November 14, 2020
• Study Completion (Actual): November 14, 2020

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: HM20018459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes