N/A
N=12
Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
Stroke · Physical Disability
Bottom Line
View on ClinicalTrials.gov: NCT04026399 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Aug 2021
Primary outcome: Primary: Short-latency Afferent Inhibition — 48; 21 % of unconditioned motor evoked potentia
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- peripheral vibration stimulation (Other); therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-latency Afferent Inhibition |
— | — |
| SECONDARY Action Research Arm Test |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04026399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.