Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2020-10-15

Brief Summary

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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.

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Detailed Description

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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

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Stroke Physical Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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stimulation + therapy

The participant receives stimulation and home therapy.

Group Type EXPERIMENTAL

peripheral vibration stimulation

Intervention Type OTHER

wearing a wristband that delivers imperceptible vibratory stimulation.

therapy

Intervention Type BEHAVIORAL

practice of daily living tasks

no stimulation + therapy

The participant receives no stimulation and receives home therapy.

Group Type SHAM_COMPARATOR

therapy

Intervention Type BEHAVIORAL

practice of daily living tasks

Interventions

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peripheral vibration stimulation

wearing a wristband that delivers imperceptible vibratory stimulation.

Intervention Type OTHER

therapy

practice of daily living tasks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No