An interventional study of Stochastic resonance (SR) wraps in Cerebral Palsy, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
The purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.
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.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 16 is below the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 82 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
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Exclusion Criteria:
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
SR applied sub threshold at 90% of participant's detection threshold
Device: Stochastic resonance (SR) wraps
SR devices worn but not turned on (0% of participant's detection threshold).
Device: Stochastic resonance (SR) wraps
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.
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.
Time frame: 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.
Time frame: Baseline to up to 1.5 hours
| Milestone | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| Started | 16 |
| Completed first assessment - approximately 15 minutes (specific treatment unknown) | 15 |
| Completed second assessment - approximately 15 minutes (specific treatment unknown) | 15 |
| Completed | 15 |
| Not completed | 1 |
| Withdrew: Patient could not follow instructions | 1 |
| Milestone | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| Started | 15 |
| Completed | 6 |
| Not completed | 9 |
| Withdrew: Patients became fatiged after a single round of testing with sham vs subthreshold | 9 |
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.
| points on assessment | Blinded Subthreshold Stochastic Resonance (SR) Vibration | Blinded Sham Treatment | Unblinded Above Threshold SR Vibration |
|---|---|---|---|
| Change in Manual Dexterity | 10.7 ± 7.1 | 12.4 ± 6.4 | 14.4 ± 6.7 |
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.
| points on assessment | Blinded Subthreshold Stochastic Resonance (SR) Vibration | Blinded Sham Treatment | Unblinded Above Threshold SR Vibration |
|---|---|---|---|
| spontaneous functional analysis | 21.2 ± 4.9 | 24.2 ± 8.8 | 30.8 ± 4.9 |
| dynamic positional analysis | 37.1 ± 13.1 | 34.4 ± 10.0 | 48.6 ± 12.2 |
Collected over 90 minutes. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blinded Subthreshold Stochastic Resonance (SR) Vibration | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Blinded Sham Treatment | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Unblinded Above Threshold SR Vibration | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| Mean | 8.5 ± 4 |
| Sex: Female, Male(Participants) | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| Female | 4 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 10 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| United States | 16 |
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