Use of Sensory Substitution to Improve Arm Control After Stroke

Sponsor
Marquette University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03298243
Collaborator
Medical College of Wisconsin (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
28
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Study Details

Study Description

Brief Summary

Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Twenty-eight subjects will be recruited to a single site to evaluate the ability of various forms of vibrotactile stimulation to improve motor function, and to determine which locations of stimulation may optimize function. Participants will be tested in performing reaching movements and stabilization movements as well as more functional tasks such as simulated drinking from a glass

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vibrotactile stimulation
N/A

Detailed Description

This study has two distinct aims. In aim 1, data will be collected across four days:

Day 1: Participants complete baseline screening including a test of cognition (Montreal Cognitive Assessment), clinical tests of sensory and motor function (Fugl-Meyer Assessment, two-point discrimination, vibration sensation) and a robotic test of proprioception (Arm Movement Detection Test).

Day 2: Participants will have their more affected hand wrapped around a robot handle. They will either perform reaching-type movements or hold the handle still if it attempts to make small movements. During these tasks, participants will receive vibrotactile feedback on the other arm which will provide information about hand position and/or hand speed to guide the movements.

Day 3: Participants will perform the holding-still task from the previous day while also performing a grip task. They will be cued to lightly squeeze and then relax their grip in the more affected hand while they are holding the handle as still as possible. During this time, they will be provided vibrotactile feedback to help them maintain hand position.

Day 4: Participants will perform the same task as the previous day. In this experiment, the vibrotactile feedback will be provided to the opposite arm, opposite thigh or on the same (grasping) arm.

In aim 2, data will be collected across ten days:

Day 1: Participants complete baseline screening including a test of cognition (Montreal Cognitive Assessment), clinical tests of sensory and motor function (Fugl-Meyer, two-point discrimination, vibration sensation) and a robotic test of proprioception (Arm Movement Detection Test).

Days 2-10: Participants will use the more affected arm to reach to specific 'unseen' targets in three-dimensional space, using vibrotactile feedback to guide the movement of the arm. Once participants reach the location, they will be asked to squeeze and release the fingers. View of a computer monitor will also be used during part of the experiment to help the participants guide the hand. Participants will also be asked to perform a simulated feeding task at the beginning or end of practice on each day.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Aim 1: Single-group cross-over study. Each participant will experience several different methods of applying vibrotactile feedback. On another day, each participant will also experience feedback applied to different body locations. Aim 2: Single-group longitudinal study. Participants will practice reaching to locations in front of them using vibrotactile feedback to guide the precision of the movements. The tasks will be organized to slowly become more difficult as practice continues. Subjects will be asked to perform simulated tasks of daily living at the beginning or end of practice to test transfer of the vibrotactile training/learning.Aim 1: Single-group cross-over study. Each participant will experience several different methods of applying vibrotactile feedback. On another day, each participant will also experience feedback applied to different body locations. Aim 2: Single-group longitudinal study. Participants will practice reaching to locations in front of them using vibrotactile feedback to guide the precision of the movements. The tasks will be organized to slowly become more difficult as practice continues. Subjects will be asked to perform simulated tasks of daily living at the beginning or end of practice to test transfer of the vibrotactile training/learning.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke
Actual Study Start Date :
Oct 30, 2017
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stroke Cohort - Optimize Delivery

Aim 1 intervention: Vibrotactile stimulation. An optimal location and style of vibrotactile feedback for reach and stabilization behaviors will be determined.

Behavioral: Vibrotactile stimulation
Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in FitBit activity monitors.

Experimental: Stroke Cohort - Extended Training

Aim2 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching and stabilizing tasks using vibrotactile feedback to guide performance

Behavioral: Vibrotactile stimulation
Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in FitBit activity monitors.

Outcome Measures

Primary Outcome Measures

  1. Root Mean Square Kinematic Error [across experimental sessions spanning a typical time frame of 1 to 3 weeks]

    orthogonal distance between target and hand position during reaching and stabilizing

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • stroke survivors who can perform our stabilization and grip modulation tasks and who

  • had a single ischemic or hemorrhagic stroke of the middle cerebral artery (MCA) in the chronic state of recovery (> 6 months post-stroke).

  • ability to give informed consent and be able to follow two-stage instructions.

  • mild-to-moderate motor impairment as assessed using the upper extremity (UE) portion of the Fugl-Meyer Motor Assessment (FM); i.e., UE-FM score between 28 and 50 (inclusive) out of a possible 66.

  • proprioceptive deficit at the elbow in the more involved (contralesional) arm.

  • preserved tactile sensation in either the ipsilesional arm and/or thigh.

  • a minimal active wrist extension of 5°.

Exclusion Criteria:
  • Inability of subjects to give informed consent or follow two-stage instructions.

  • subjects with a bleeding disorder.

  • subjects with fixed contractures or a history of tendon transfer in the involved limb.

  • subjects with a diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any disease that might interfere with neuromuscular function.

  • subjects who are currently using or under the influence of aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function.

  • subjects with a history of epilepsy.

  • history of other psychiatric co-morbidities (e.g. schizophrenia).

  • malignant or benign intra-axial neoplasms.

  • concurrent illness limiting the capacity to conform to study requirements.

  • Cardiac pacemaker, cardiac arrhythmia or history of significant cardiovascular or respiratory compromise.

  • subjects with profound atrophy or excessive weakness of muscles in the target area(s) of testing.

  • subjects with a systemic infection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marquette University Milwaukee Wisconsin United States 53233

Sponsors and Collaborators

  • Marquette University
  • Medical College of Wisconsin
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Leigh A Mrotek, PhD, Marquette University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marquette University
ClinicalTrials.gov Identifier:
NCT03298243
Other Study ID Numbers:
  • HR-3303
  • 1R15HD093086
First Posted:
Oct 2, 2017
Last Update Posted:
Feb 19, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marquette University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 19, 2020