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

Primary Purpose

Stroke, Physical Disability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
peripheral vibration stimulation
therapy
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Caorlina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

stimulation + therapy

no stimulation + therapy

Arm Description

The participant receives stimulation and home therapy.

The participant receives no stimulation and receives home therapy.

Outcomes

Primary Outcome Measures

Short-latency Afferent Inhibition
motor evoked potential suppression by conditioning electrical stimulation

Secondary Outcome Measures

Action Research Arm Test
standardized clinical upper extremity function score

Full Information

First Posted
July 18, 2019
Last Updated
July 28, 2021
Sponsor
Medical University of South Carolina
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04026399
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Physical Disability
Keywords
physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stimulation + therapy
Arm Type
Experimental
Arm Description
The participant receives stimulation and home therapy.
Arm Title
no stimulation + therapy
Arm Type
Sham Comparator
Arm Description
The participant receives no stimulation and receives home therapy.
Intervention Type
Other
Intervention Name(s)
peripheral vibration stimulation
Intervention Description
wearing a wristband that delivers imperceptible vibratory stimulation.
Intervention Type
Behavioral
Intervention Name(s)
therapy
Intervention Description
practice of daily living tasks
Primary Outcome Measure Information:
Title
Short-latency Afferent Inhibition
Description
motor evoked potential suppression by conditioning electrical stimulation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Description
standardized clinical upper extremity function score
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Stroke Impact Scale Hand Subscale
Description
standardized patient-reported hand function assessment
Time Frame
1 month
Title
Stoke Impact Scale Hand Subscale
Description
standardized patient-reported hand function assessment
Time Frame
4 month
Title
Timing of Reactive Force Generation Per Perturbation
Description
time of reactive force
Time Frame
1 month
Title
Timing of Reactive Force Generation Per Perturbation
Description
time of reactive force
Time Frame
4 month
Title
Fugl-Meyer Upper Limb Assessment
Description
standardized clinical upper extremity function score
Time Frame
1 month
Title
Fugl-Meyer Upper Limb Assessment
Description
standardized clinical upper extremity function score
Time Frame
4 month
Title
Grip Force Direction
Description
angle of the grip force vector from the normal direction
Time Frame
1 month
Title
Grip Force Direction
Description
angle of the grip force vector from the normal direction
Time Frame
4 month
Title
In-home Hand Use Amount
Description
affected hand use amount as measured by accelerometers
Time Frame
1 month
Title
In-home Hand Use Amount
Description
affected hand use amount as measured by accelerometers
Time Frame
4 month
Title
Reactive Force Magnitude Per Perturbation
Description
magnitude of reactive grip force
Time Frame
1 month
Title
Reactive Force Magnitude Per Perturbation
Description
magnitude of reactive grip force
Time Frame
4 month
Title
Safety Margin
Description
additional force used during grip
Time Frame
1 month
Title
Safety Margin
Description
additional force used during grip
Time Frame
4 month
Title
Corticomotor Excitability
Description
motor evoked potential amplitude
Time Frame
1 month
Title
Corticomotor Excitability
Description
motor evoked potential amplitude
Time Frame
4 month
Title
Spectral Power Perturbation During Grip
Description
EEG spectral power perturbation during grip
Time Frame
1 month
Title
Spectral Power Perturbation During Grip
Description
EEG spectral power perturbation during grip
Time Frame
4 month
Title
Connectivity
Description
EEG coherence within the sensorimotor network
Time Frame
1 month
Title
Connectivity
Description
EEG coherence within the sensorimotor network
Time Frame
4 month
Title
Short-latency Afferent Inhibition
Description
motor evoked potential suppression by conditioning electrical stimulation
Time Frame
4 month
Title
Box and Block Test
Description
number of blocks moved in a minute
Time Frame
1 month
Title
Box and Block Test
Description
number of blocks moved in a minute
Time Frame
4 month
Title
Wolf Motor Function Test
Description
standardized clinical upper extremity function score
Time Frame
1 month
Title
Wolf Motor Function Test
Description
standardized clinical upper extremity function score
Time Frame
4 month
Title
Action Research Arm Test
Description
standardized clinical upper extremity function score
Time Frame
4 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Kautz, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of South Caorlina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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

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