Cerebral PalsyNCT04388787
Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy
A study testing Stochastic resonance (SR) wraps in people with Cerebral Palsy, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Stochastic resonance (SR) wraps
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 14 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Stochastic resonance (SR) wraps
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic resonance (SR) wrapsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| stochastic resonance (SR) vibration | Experimental | SR applied sub threshold at 90% of participant's detection threshold Receives: Device: Stochastic resonance (SR) wraps |
| Sham treatment | Sham comparator | SR devices worn but not turned on (0% of participant's detection threshold). Receives: Device: Stochastic resonance (SR) wraps |
| Unblinded treatment | Experimental | SR is applied above participant's detection threshold at a participant selected intensity. Receives: Device: Stochastic resonance (SR) wraps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to up to 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start10 Jul 2020
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388787
- Sponsor's protocol ID
- HM20018459
- Status last verified
- Jan 2022
- First submitted
- 13 May 2020
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04388787
- Acronym / sponsor ID
- HM20018459
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stochastic resonance (SR) vibration | Experimental | Device: Stochastic resonance (SR) wrapsSR applied sub threshold at 90% of participant's detection threshold |
| Sham treatment | Sham comparator | Device: Stochastic resonance (SR) wrapsSR devices worn but not turned on (0% of participant's detection threshold). |
| Unblinded treatment | Experimental | Device: Stochastic resonance (SR) wrapsSR is applied above participant's detection threshold at a participant selected intensity. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stochastic resonance (SR) wrapsSR 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. | Device | Sham treatment, Unblinded treatment, stochastic resonance (SR) vibration |
Primary outcome
Change in Manual Dexterity
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic resonance (SR) wraps in people with Cerebral Palsy, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Manual Dexterity (time frame: Baseline to up to 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.