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Use of Sensory Substitution to Improve Arm Control After Stroke

Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03298243
Enrollment
30
Registered
2017-10-02
Start date
2023-07-17
Completion date
2026-05-31
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proprioceptive Disorders, Stroke

Keywords

stroke, proprioception, sensory substitution

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. 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.

Interventions

Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in off-the-shelf activity monitors.

Sponsors

Medical College of Wisconsin
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Marquette University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Aims 1 and 2: Parallel-group longitudinal study. Participants will practice reaching to locations in front of them using vibrotactile feedback to guide the precision of the movements. For one group, the tasks will be organized to slowly become more difficult as practice continues. For the other group, the training will only involve the more difficult task. 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.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Root Mean Square Kinematic Erroracross experimental sessions spanning a typical time frame of 4 to 6 weeksorthogonal distance between target and hand position during reaching and stabilizing

Countries

United States

Contacts

Primary ContactRobert A Scheidt, PhD
robert.scheidt@marquette.edu(414)288-6124
Backup ContactKimberly D Bassindale, DPT
kimberly.bassindale@marquette.edu(414)288-6184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 25, 2026