免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke Physical Disability | Other: peripheral vibration stimulation Behavioral: therapy | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke |
| Actual Study Start Date : | July 8, 2019 |
| Actual Primary Completion Date : | October 15, 2020 |
| Actual Study Completion Date : | October 15, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: stimulation + therapy
The participant receives stimulation and home therapy.
|
Other: peripheral vibration stimulation
wearing a wristband that delivers imperceptible vibratory stimulation.
Behavioral: therapy practice of daily living tasks
|
|
Sham Comparator: no stimulation + therapy
The participant receives no stimulation and receives home therapy.
|
Behavioral: therapy
practice of daily living tasks
|
Outcome Measures
Primary Outcome Measures :
- short-latency afferent inhibition [ Time Frame: 1 month ]motor evoked potential suppression by conditioning electrical stimulation
Secondary Outcome Measures :
- Action Research Arm Test [ Time Frame: 1 month ]standardized clinical upper extremity function score
Other Outcome Measures:
- Stoke Impact Scale hand subscale [ Time Frame: 1 month ]standardized patient-reported hand function assessment
- Stoke Impact Scale hand subscale [ Time Frame: 4 month ]standardized patient-reported hand function assessment
- timing of reactive force generation per perturbation [ Time Frame: 1 month ]time of reactive force
- timing of reactive force generation per perturbation [ Time Frame: 4 month ]time of reactive force
- Fugl-Meyer upper limb assessment [ Time Frame: 1 month ]standardized clinical upper extremity function score
- Fugl-Meyer upper limb assessment [ Time Frame: 4 month ]standardized clinical upper extremity function score
- grip force direction [ Time Frame: 1 month ]angle of the grip force vector from the normal direction
- grip force direction [ Time Frame: 4 month ]angle of the grip force vector from the normal direction
- in-home hand use amount [ Time Frame: 1 month ]affected hand use amount as measured by accelerometers
- in-home hand use amount [ Time Frame: 4 month ]affected hand use amount as measured by accelerometers
- reactive force magnitude per perturbation [ Time Frame: 1 month ]magnitude of reactive grip force
- reactive force magnitude per perturbation [ Time Frame: 4 month ]magnitude of reactive grip force
- safety margin [ Time Frame: 1 month ]additional force used during grip
- safety margin [ Time Frame: 4 month ]additional force used during grip
- corticomotor excitability [ Time Frame: 1 month ]motor evoked potential amplitude
- corticomotor excitability [ Time Frame: 4 month ]motor evoked potential amplitude
- spectral power perturbation during grip [ Time Frame: 1 month ]EEG spectral power perturbation during grip
- spectral power perturbation during grip [ Time Frame: 4 month ]EEG spectral power perturbation during grip
- connectivity [ Time Frame: 1 month ]EEG coherence within the sensorimotor network
- connectivity [ Time Frame: 4 month ]EEG coherence within the sensorimotor network
- short-latency afferent inhibition [ Time Frame: 4 month ]motor evoked potential suppression by conditioning electrical stimulation
- Box and Block Test [ Time Frame: 1 month ]number of blocks moved in a minute
- Box and Block Test [ Time Frame: 4 month ]number of blocks moved in a minute
- Wolf Motor Function Test [ Time Frame: 1 month ]standardized clinical upper extremity function score
- Wolf Motor Function Test [ Time Frame: 4 month ]standardized clinical upper extremity function score
- Action Research Arm Test [ Time Frame: 4 month ]standardized clinical upper extremity function score
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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.
Contacts and Locations
Locations
| United States, South Carolina | |
| Medical University of South Caorlina | |
| Charleston, South Carolina, United States, 29425 | |
Sponsors and Collaborators
Medical University of South Carolina
National Institute of General Medical Sciences (NIGMS)
Investigators
| Study Chair: | Steven Kautz, PhD | Medical University of South Carolina |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 18, 2019 | ||||
| First Posted Date ICMJE | July 19, 2019 | ||||
| Last Update Posted Date | January 25, 2021 | ||||
| Actual Study Start Date ICMJE | July 8, 2019 | ||||
| Actual Primary Completion Date | October 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
short-latency afferent inhibition [ Time Frame: 1 month ] motor evoked potential suppression by conditioning electrical stimulation
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
Action Research Arm Test [ Time Frame: 1 month ] standardized clinical upper extremity function score
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Pre-specified Outcome Measures |
|
||||
| Original Other Pre-specified Outcome Measures |
|
||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke | ||||
| Official Title ICMJE | Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke | ||||
| Brief 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. 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
12 | ||||
| Original Estimated Enrollment ICMJE |
40 | ||||
| Actual Study Completion Date ICMJE | October 15, 2020 | ||||
| Actual Primary Completion Date | October 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS. |
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04026399 | ||||
| Other Study ID Numbers ICMJE | Pro00086207 P20GM109040 ( U.S. NIH Grant/Contract ) |
||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Medical University of South Carolina | ||||
| Study Sponsor ICMJE | Medical University of South Carolina | ||||
| Collaborators ICMJE | National Institute of General Medical Sciences (NIGMS) | ||||
| Investigators ICMJE |
|
||||
| PRS Account | Medical University of South Carolina | ||||
| Verification Date | January 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
