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

Not Applicable

Completed

• Conditions: Stroke; Physical Disability
• Interventions: Other: peripheral vibration stimulation; Behavioral: therapy

• Registration Number: NCT04026399
• Lead Sponsor: Medical University of South Carolina

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 Timeline

• Study Start: 2019-07-08
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-07
• Results First Submitted: 2021-07-28
• Results First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Results First Posted: 2021-08-23
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stimulation + therapy	peripheral vibration stimulation	The participant receives stimulation and home therapy.
no stimulation + therapy	therapy	The participant receives no stimulation and receives home therapy.
stimulation + therapy	therapy	The participant receives stimulation and home therapy.

Primary Outcome Measures

Name	Time	Method
Short-latency Afferent Inhibition	1 month	motor evoked potential suppression by conditioning electrical stimulation

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	1 month	standardized clinical upper extremity function score

Trial Locations

Locations (1)

Medical University of South Caorlina; 🇺🇸 Charleston, South Carolina, United States