Trial Outcomes & Findings for Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy (NCT NCT04388787)

Last Updated: 2022-01-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Baseline to up to 1.5 hours

Results posted on

2022-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration There was only one arm to the study. Participants were not assigned to different arms based on order of treatment because treatment order was not relevant to the outcome and was not tracked in the data set. Each participant completed all treatments in one session. Order of blinded and sham treatments was randomized at the time data was collected. The unblinded treatment was always last. Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments under 3 treatments, the first two in random order and the third always last: Blinded: SR applied sub threshold at 90% of participant's detection threshold Blinded Sham: SR devices worn but not turned on (0% of participant's detection threshold). Unblinded: SR is applied above participant's detection threshold at a participant selected intensity.
Blinded Period STARTED	16
Blinded Period Completed First Assessment - Approximately 15 Minutes (Specific Treatment Unknown)	15
Blinded Period Completed Second Assessment - Approximately 15 Minutes (Specific Treatment Unknown)	15
Blinded Period COMPLETED	15
Blinded Period NOT COMPLETED	1
Unblinded Period STARTED	15
Unblinded Period COMPLETED	6
Unblinded Period NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration There was only one arm to the study. Participants were not assigned to different arms based on order of treatment because treatment order was not relevant to the outcome and was not tracked in the data set. Each participant completed all treatments in one session. Order of blinded and sham treatments was randomized at the time data was collected. The unblinded treatment was always last. Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments under 3 treatments, the first two in random order and the third always last: Blinded: SR applied sub threshold at 90% of participant's detection threshold Blinded Sham: SR devices worn but not turned on (0% of participant's detection threshold). Unblinded: SR is applied above participant's detection threshold at a participant selected intensity.
Blinded Period Patient could not follow instructions	1
Unblinded Period Patients became fatiged after a single round of testing with sham vs subthreshold	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration n=16 Participants There was only one arm to the study. Participants were not assigned to different arms based on order of treatment because treatment order was not relevant to the outcome and was not tracked in the data set. Each participant completed all treatments in one session. Order of blinded and sham treatments was randomized at the time data was collected. The unblinded treatment was always last. Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments under 3 treatments, the first two in random order and the third always last: Blinded: SR applied sub threshold at 90% of participant's detection threshold Blinded Sham: SR devices worn but not turned on (0% of participant's detection threshold). Unblinded: SR is applied above participant's detection threshold at a participant selected intensity.
Age, Continuous	8.5 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to up to 1.5 hours

Population: Data from all participants who completed the blinded portion of the study were analyzed for the subthreshold and sham treatments. Only participants who completed the unblinded portion were analyzed for the above threshold treatment

Outcome measures

Outcome measures
Measure	Blinded Subthreshold Stochastic Resonance (SR) Vibration n=15 Participants Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments with SR vibration applied sub threshold at 90% of participant's detection threshold.	Blinded Sham Treatment n=15 Participants Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments with SR devices worn but not turned on (0% of participant's detection threshold).	Unblinded Above Threshold SR Vibration n=6 Participants Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments SR is applied above participant's detection threshold at a participant selected intensity.
Change in Manual Dexterity	10.7 points on assessment Standard Deviation 7.1	12.4 points on assessment Standard Deviation 6.4	14.4 points on assessment Standard Deviation 6.7

PRIMARY outcome

Timeframe: Baseline to up to 1.5 hours

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.

Outcome measures

Outcome measures
Measure	Blinded Subthreshold Stochastic Resonance (SR) Vibration n=15 Participants Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments with SR vibration applied sub threshold at 90% of participant's detection threshold.	Blinded Sham Treatment n=15 Participants Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments with SR devices worn but not turned on (0% of participant's detection threshold).	Unblinded Above Threshold SR Vibration n=6 Participants Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold. Once the detection threshold was established, participant completed the assessments SR is applied above participant's detection threshold at a participant selected intensity.
Change in Upper Extremity Functionality spontaneous functional analysis	21.2 points on assessment Standard Deviation 4.9	24.2 points on assessment Standard Deviation 8.8	30.8 points on assessment Standard Deviation 4.9
Change in Upper Extremity Functionality dynamic positional analysis	37.1 points on assessment Standard Deviation 13.1	34.4 points on assessment Standard Deviation 10.0	48.6 points on assessment Standard Deviation 12.2

Adverse Events

Blinded Subthreshold Stochastic Resonance (SR) Vibration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blinded Sham Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unblinded Above Threshold SR Vibration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Olivier Rolin, MD, PhD

Virginia Commonwealth University

Phone: (804) 828-4230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place