Cerebral Palsy
Conditions
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.
Interventions
DEVICEStochastic 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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Manual Dexterity | Baseline to up to 1.5 hours | 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. |
| Change in Upper Extremity Functionality | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration |
|---|---|
| Age, Continuous | 8.5 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 6 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 6 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 6 |
Outcome results
Primary
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Subthreshold Stochastic Resonance (SR) Vibration | Change in Manual Dexterity | 10.7 points on assessment | Standard Deviation 7.1 |
| Blinded Sham Treatment | Change in Manual Dexterity | 12.4 points on assessment | Standard Deviation 6.4 |
| Unblinded Above Threshold SR Vibration | Change in Manual Dexterity | 14.4 points on assessment | Standard Deviation 6.7 |
p-value: 0.03ANCOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Subthreshold Stochastic Resonance (SR) Vibration | Change in Upper Extremity Functionality | spontaneous functional analysis | 21.2 points on assessment | Standard Deviation 4.9 |
| Blinded Subthreshold Stochastic Resonance (SR) Vibration | Change in Upper Extremity Functionality | dynamic positional analysis | 37.1 points on assessment | Standard Deviation 13.1 |
| Blinded Sham Treatment | Change in Upper Extremity Functionality | spontaneous functional analysis | 24.2 points on assessment | Standard Deviation 8.8 |
| Blinded Sham Treatment | Change in Upper Extremity Functionality | dynamic positional analysis | 34.4 points on assessment | Standard Deviation 10 |
| Unblinded Above Threshold SR Vibration | Change in Upper Extremity Functionality | spontaneous functional analysis | 30.8 points on assessment | Standard Deviation 4.9 |
| Unblinded Above Threshold SR Vibration | Change in Upper Extremity Functionality | dynamic positional analysis | 48.6 points on assessment | Standard Deviation 12.2 |
p-value: 0.0008ANCOVA