StrokeNCT04026399
Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
A study testing peripheral vibration stimulation and therapy in people with Stroke and Physical Disability, run by Medical University of South Carolina at 1 site in United States.
Trial summary
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Physical Disability
- What is being tested?
- peripheral vibration stimulation and therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 15 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke survivor (>= 6 months post stroke)
- Ability to move an object with the paretic hand
- Fingertip sensory deficits
- Ability to put on a watch daily (by oneself or with help)
Who cannot join
- Currently undergoing other upper extremity rehabilitation therapy
- Upper limb botulinum toxin within 3 months prior to or during enrollment
- Change in neurological disorder medications during the enrollment
- Complete upper limb deafferentation
- Rigidity (Modified Ashworth Scale=5)
- Brainstem stroke
Show all 9Show fewer
- Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
- Language barrier or cognitive impairment that precludes following instructions and/or providing consent
- If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Caorlina
Charleston, South Carolina, 29425
About this study
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.
Read the detailed description
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).
- Conditions
- Stroke, Physical Disability
- Being tested
- peripheral vibration stimulation, therapy
- Keywords
- physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral vibration stimulationOther
wearing a wristband that delivers imperceptible vibratory stimulation.
therapyBehavioural
practice of daily living tasks
| Study group | Role | What they receive |
|---|---|---|
| stimulation + therapy | Experimental | The participant receives stimulation and home therapy. Receives: Other: peripheral vibration stimulation; Behavioral: therapy |
| no stimulation + therapy | Sham comparator | The participant receives no stimulation and receives home therapy. Receives: Behavioral: therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-latency Afferent Inhibition
motor evoked potential suppression by conditioning electrical stimulation
Measured: 1 month
Secondary outcomes (1)
Action Research Arm Test
standardized clinical upper extremity function score
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start8 Jul 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Steven Kautz, PhD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026399
- Sponsor's protocol ID
- Pro00086207
- Other IDs
- P20GM109040
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2019
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scronce G, Ramakrishnan V, Vatinno AA, Seo NJ. Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. Stroke Res Treat. 2023 Mar 8;2023:3682898. doi: 10.1155/2023/3682898. eCollection 2023.
PubMed 36936523
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
- ClinicalTrials.gov ID
- NCT04026399
- Acronym / sponsor ID
- Pro00086207
- Conditions
- Stroke, Physical Disability
- Keywords
- physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 23 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.
Detailed description
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation + therapy | Experimental | Other: peripheral vibration stimulation, Behavioral: therapyThe participant receives stimulation and home therapy. |
| no stimulation + therapy | Sham comparator | Behavioral: therapyThe participant receives no stimulation and receives home therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke survivor (>= 6 months post stroke)
- Ability to move an object with the paretic hand
- Fingertip sensory deficits
- Ability to put on a watch daily (by oneself or with help)
Key exclusion criteria (9 listed)
- Currently undergoing other upper extremity rehabilitation therapy
- Upper limb botulinum toxin within 3 months prior to or during enrollment
- Change in neurological disorder medications during the enrollment
- Complete upper limb deafferentation
- Rigidity (Modified Ashworth Scale=5)
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 |
|---|---|---|
| peripheral vibration stimulationwearing a wristband that delivers imperceptible vibratory stimulation. | Other | stimulation + therapy |
| therapypractice of daily living tasks | Behavioural | no stimulation + therapy, stimulation + therapy |
Primary outcome
Short-latency Afferent Inhibition
Time frame: 1 month
motor evoked potential suppression by conditioning electrical stimulation
1 secondary outcome
Action Research Arm Test
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36936523Scronce G, Ramakrishnan V, Vatinno AA, Seo NJ. Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. Stroke Res Treat. 2023 Mar 8;2023:3682898. doi: 10.1155/2023/3682898. eCollection 2023.
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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.
Steven Kautz, PhD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral vibration stimulation and therapy in people with Stroke and Physical Disability, run by Medical University of South Carolina 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 9 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 23 Aug 2021. 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 23 Aug 2021). 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?
Short-latency Afferent Inhibition (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026399, which also lists 1 linked publication.
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 23 Aug 2021.