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

NCT04388787 | Completed Results FDA Device

• 1 other identifier: HM20018459
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

stochastic resonance (SR) vibration

EXPERIMENTAL

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

Device: Stochastic resonance (SR) wraps

Sham treatment

SHAM COMPARATOR

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

Device: Stochastic resonance (SR) wraps

Unblinded treatment

EXPERIMENTAL

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

Device: Stochastic resonance (SR) wraps

Interventions

Stochastic resonance (SR) wraps 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; Unblinded treatment; stochastic resonance (SR) vibration

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with cerebral palsy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Olivier Rolin, MD, PhD
• Organization: Virginia Commonwealth University

olivier.rolin@vcuhealth.org

(804) 828-4230

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 14, 2020
• Study Start: July 10, 2020
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)