Clinical trial NCT04026399: Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
Official title: Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Physical Disability
Keywords: physical stimulation
Subliminal stimulation
stroke rehabilitation
upper extremity
paresis
hand function
occupational therapy
physical therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2019-07-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Short-latency Afferent Inhibition
timeFrame: 1 month
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: 1 month
Other outcomes:
measure: Stroke Impact Scale Hand Subscale
timeFrame: 1 month
measure: Stoke Impact Scale Hand Subscale
timeFrame: 4 month
measure: Timing of Reactive Force Generation Per Perturbation
timeFrame: 1 month
measure: Timing of Reactive Force Generation Per Perturbation
timeFrame: 4 month
measure: Fugl-Meyer Upper Limb Assessment
timeFrame: 1 month
measure: Fugl-Meyer Upper Limb Assessment
timeFrame: 4 month
measure: Grip Force Direction
timeFrame: 1 month
measure: Grip Force Direction
timeFrame: 4 month
measure: In-home Hand Use Amount
timeFrame: 1 month
measure: In-home Hand Use Amount
timeFrame: 4 month
measure: Reactive Force Magnitude Per Perturbation
timeFrame: 1 month
measure: Reactive Force Magnitude Per Perturbation
timeFrame: 4 month
measure: Safety Margin
timeFrame: 1 month
measure: Safety Margin
timeFrame: 4 month
measure: Corticomotor Excitability
timeFrame: 1 month
measure: Corticomotor Excitability
timeFrame: 4 month
measure: Spectral Power Perturbation During Grip
timeFrame: 1 month
measure: Spectral Power Perturbation During Grip
timeFrame: 4 month
measure: Connectivity
timeFrame: 1 month
measure: Connectivity
timeFrame: 4 month
measure: Short-latency Afferent Inhibition
timeFrame: 4 month
measure: Box and Block Test
timeFrame: 1 month
measure: Box and Block Test
timeFrame: 4 month
measure: Wolf Motor Function Test
timeFrame: 1 month
measure: Wolf Motor Function Test
timeFrame: 4 month
measure: Action Research Arm Test
timeFrame: 4 month
Locations:
city: Charleston
country: United States
facility: Medical University of South Caorlina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Steven Kautz, PhD
role: STUDY_CHAIR
References: