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Sensory Stimulation to Enhance Hand Function Post Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibration
Placebo (for vibration)
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 hand function

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • mild to moderate impairment in upper extremity function

Exclusion Criteria:

  • cognitive dysfunction
  • stroke<3 months
  • treatment with botulinum toxin in the affected arm within 3 months of start of study

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Placebo

Arm Description

The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.

The control group will wear the vibration device with no vibration. Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.

Outcomes

Primary Outcome Measures

Box and Block Test (BBT) About a Week After the 2-week Intervention
Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention
Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
WMFT About a Week After the 2-week Intervention
change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.
WMFT at Least 2 Weeks After the 2-week Intervention
change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2016
Last Updated
January 9, 2019
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
NCT02675764
Brief Title
Sensory Stimulation to Enhance Hand Function Post Stroke
Official Title
Sensory Stimulation to Enhance Hand Function Post Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
March 30, 2017 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of hand therapy as well as the central nervous system responsiveness in chronic stroke survivors.
Detailed Description
Stroke survivors suffer from persistent hand impairment that diminishes their functional abilities and independence, despite multiple courses of rehabilitation. Sensory stimulation can prime central excitability to increase therapy outcome. The investigators developed a new sensory stimulation technique for the hand, using imperceptible vibration applied to the wrist skin. Wearable devices with a vibrating function are low cost and can be easily adopted for rehabilitation purposes to impact a wide range of patients with sensorimotor impairment. Despite the potential for clinical benefits and easy adoption for high impact, knowledge about the long-term efficacy of this new sensory stimulation technique and its underlying mechanism is limited. The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of 2-week hand therapy as well as the central nervous system responsiveness in chronic stroke survivors. This impact will be assessed in a double-blind stratified randomized controlled trial. The hypothesis is that (a) improvement in hand function will be greater for the experimental group receiving the wrist subthreshold vibrotactile stimulation during therapy compared with the control group who will wear the device with no vibration (placebo). (b) Improvement in hand function is associated with neurophysiologic measures of central nervous system responsiveness. Clinical and neurophysiologic evaluations will be performed before, immediately after, and 2 weeks after a 2 week standardized hand therapy program with the subthreshold vibrotactile stimulation to the wrist vs. sham. The investigators preliminary studies demonstrated an acute effect of the remote subthreshold vibrotactile stimulation on immediately improved clinical sensory and motor function of the hand as well as cortical excitability in healthy young adults and chronic stroke survivors in single-session studies. The expected outcome is the demonstration that the subthreshold vibrotactile stimulation at the wrist enhances hand function, not only immediately (preliminary studies) but also as a complement to therapy in chronic stroke survivors. This project will also provide preliminary insights regarding plasticity occurring with hand therapy augmented by the subthreshold vibrotactile stimulation. This research will have a positive impact by leading to a portable sensorimotor orthosis worn at the wrist to improve hand function for patients with sensorimotor deficits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
hand function

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
Experimental
Arm Type
Experimental
Arm Description
The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
The control group will wear the vibration device with no vibration. Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
Intervention Type
Other
Intervention Name(s)
Vibration
Intervention Description
peripheral vibration at the wrist skin at an imperceptible level
Intervention Type
Other
Intervention Name(s)
Placebo (for vibration)
Intervention Description
No peripheral vibration at the wrist skin
Intervention Type
Behavioral
Intervention Name(s)
therapy
Intervention Description
standardized hand therapy program
Primary Outcome Measure Information:
Title
Box and Block Test (BBT) About a Week After the 2-week Intervention
Description
Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Time Frame
post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
Title
Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention
Description
Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Time Frame
follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)
Title
WMFT About a Week After the 2-week Intervention
Description
change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.
Time Frame
post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
Title
WMFT at Least 2 Weeks After the 2-week Intervention
Description
change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.
Time Frame
follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mild to moderate impairment in upper extremity function Exclusion Criteria: cognitive dysfunction stroke<3 months treatment with botulinum toxin in the affected arm within 3 months of start of study
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 Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30690609
Citation
Seo NJ, Woodbury ML, Bonilha L, Ramakrishnan V, Kautz SA, Downey RJ, Dellenbach BHS, Lauer AW, Roark CM, Landers LE, Phillips SK, Vatinno AA. TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Phys Ther. 2019 Mar 1;99(3):319-328. doi: 10.1093/ptj/pzy143.
Results Reference
derived

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Sensory Stimulation to Enhance Hand Function Post Stroke

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