Use of Sensory Substitution to Improve Arm Control After Stroke

November 21, 2023 updated by: Marquette University

Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke

Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Thirty subjects will be recruited to a single site to evaluate the ability of supplemental kinesthetic feedback (a form of vibrotactile stimulation) to improve motor function. Participants will be tested in performing reaching movements as well as more functional tasks such as simulated drinking from a glass

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study has two distinct aims to be addressed in a longitudinal study spanning 24 days.

Aim 1 tests the hypothesis that stroke survivors can improve motor control of their contralesional arm through extended training with supplemental kinesthetic feedback applied to the non-moving arm and hand.

Aim 2 tests the hypothesis that extended training with supplemental kinesthetic feedback can lead to new skills that generalize to untrained reach-to-grasp actions like reaching for a water glass or a book on a shelf.

Day 1: Participants complete baseline tests of cognitive performance over several domains, including psychomotor speed (e.g., Symbol Digit Modalities Test; Digit Copy Test), memory (Rey Auditory Verbal Learning Test; Rey Osterrieth Complex Figure Test), cognitive flexibility/attention shifting (Trail-Making Test B; Wisconsin Card Sort Test), spatial processing (Rey Osterrieth Complex Figure copy test), and action selection/inhibition. (the go, no-go, and stop signal tests).

Day 2: Participants complete baseline tests of sensorimotor impairment and function. Tests of sensorimotor impairment include the upper extremity Fugl-Meyer Assessment for the contralesional arm, two-point discrimination, vibration sensation using a 128 Hz tuning fork, and a robotic test of proprioception in both arms. Motor function in the contralesional arm will be assessed using the Jamar grip strength assessment and the Wolf Motor Function Test.

Day 3: We will test the subjects on their naïve capability to use a 3-Degree-Of-Freedom (3-DOF) vibrotactile display to guide supported (but unconstrained) 3D movements mimicking reach-to-grasp actions like reaching for a water glass or a book on a shelf. The vibrotactile display will provide supplemental kinesthetic feedback of limb movement.

Days 4-23: These 20 sessions train participants on the use of of supplemental kinesthetic feedback of limb movement. We will test two groups of 15 stroke survivors each. Subjects will use supplemental vibrotactile feedback to guide goal-directed reach-to-grasp movements to targets presented visually in 3D space. Individuals assigned to the PROGRESSIVE TRAINING group will practice for several days on interpreting feedback along just one dimension of movement before training to interpret 2 dimensions of feedback. they will conclude training by training to interpret 3D vibrotactile feedback. Individuals assigned to the 3D TRAINING group will only train on the full 3D feedback system.

Day 24: We will re-test the subjects on their capability to use a 3-DOF vibrotactile display to guide supported (but unconstrained) 3D movements mimicking reach-to-grasp actions like reaching for a water glass or a book on a shelf.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke Cohort - Progressive Training
Aim 1 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching task using vibrotactile feedback to guide performance
Behavioral: Vibrotactile stimulation
Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in off-the-shelf activity monitors.
Experimental: Stroke Cohort - Whole Task Training
Aim2 intervention: Vibrotactile stimulation. Training on only the more complex reaching task using vibrotactile feedback to guide performance
Behavioral: Vibrotactile stimulation
Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in off-the-shelf activity monitors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root Mean Square Kinematic Error
Time Frame: across experimental sessions spanning a typical time frame of 4 to 6 weeks
orthogonal distance between target and hand position during reaching and stabilizing
across experimental sessions spanning a typical time frame of 4 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marquette University

Collaborators

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

Investigators

  • Principal Investigator: Robert A Scheidt, PhD, Marquette University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-3303
  • 1R15HD093086 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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