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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Physical Disability
• Intervention / Treatment: Other: peripheral vibration stimulation; Behavioral: therapy

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: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Caorlina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-latency Afferent Inhibition	motor evoked potential suppression by conditioning electrical stimulation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test	standardized clinical upper extremity function score	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale Hand Subscale	standardized patient-reported hand function assessment	1 month
Stoke Impact Scale Hand Subscale	standardized patient-reported hand function assessment	4 month
Timing of Reactive Force Generation Per Perturbation	time of reactive force	1 month
Timing of Reactive Force Generation Per Perturbation	time of reactive force	4 month
Fugl-Meyer Upper Limb Assessment	standardized clinical upper extremity function score	1 month
Fugl-Meyer Upper Limb Assessment	standardized clinical upper extremity function score	4 month
Grip Force Direction	angle of the grip force vector from the normal direction	1 month
Grip Force Direction	angle of the grip force vector from the normal direction	4 month
In-home Hand Use Amount	affected hand use amount as measured by accelerometers	1 month
In-home Hand Use Amount	affected hand use amount as measured by accelerometers	4 month
Reactive Force Magnitude Per Perturbation	magnitude of reactive grip force	1 month
Reactive Force Magnitude Per Perturbation	magnitude of reactive grip force	4 month
Safety Margin	additional force used during grip	1 month
Safety Margin	additional force used during grip	4 month
Corticomotor Excitability	motor evoked potential amplitude	1 month
Corticomotor Excitability	motor evoked potential amplitude	4 month
Spectral Power Perturbation During Grip	EEG spectral power perturbation during grip	1 month
Spectral Power Perturbation During Grip	EEG spectral power perturbation during grip	4 month
Connectivity	EEG coherence within the sensorimotor network	1 month
Connectivity	EEG coherence within the sensorimotor network	4 month
Short-latency Afferent Inhibition	motor evoked potential suppression by conditioning electrical stimulation	4 month
Box and Block Test	number of blocks moved in a minute	1 month
Box and Block Test	number of blocks moved in a minute	4 month
Wolf Motor Function Test	standardized clinical upper extremity function score	1 month
Wolf Motor Function Test	standardized clinical upper extremity function score	4 month
Action Research Arm Test	standardized clinical upper extremity function score	4 month

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2019
• Primary Completion (ACTUAL): October 15, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (ACTUAL): July 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: physical therapy; occupational therapy; paresis; upper extremity; stroke rehabilitation; physical stimulation; Subliminal stimulation; hand function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Pro00086207; P20GM109040 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No