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Clinical Trials/NCT03298243
NCT03298243RecruitingNot Applicable

Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke

Marquette University2 sites in 1 country30 target enrollmentStarted: July 17, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
Root Mean Square Kinematic Error

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
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
  • •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.

Arms & Interventions

Stroke Cohort - Progressive Training

Experimental

Aim 1 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching task using vibrotactile feedback to guide performance

Intervention: Vibrotactile stimulation (Behavioral)

Stroke Cohort - Whole Task Training

Experimental

Aim2 intervention: Vibrotactile stimulation. Training on only the more complex reaching task using vibrotactile feedback to guide performance

Intervention: Vibrotactile stimulation (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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