Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03298243
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2017-09-22
Brief Title:
Use of Sensory Substitution to Improve Arm Control After Stroke
Sponsor:
Marquette University
Organization:
Marquette University
Study Overview
Official Title:
Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg Symbol Digit Modalities Test Digit Copy Test memory Rey Auditory Verbal Learning Test Rey Osterrieth Complex Figure Test cognitive flexibilityattention shifting Trail-Making Test B Wisconsin Card Sort Test spatial processing Rey Osterrieth Complex Figure copy test and action selectioninhibition 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
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 eg Symbol Digit Modalities Test Digit Copy Test memory Rey Auditory Verbal Learning Test Rey Osterrieth Complex Figure Test cognitive flexibilityattention shifting Trail-Making Test B Wisconsin Card Sort Test spatial processing Rey Osterrieth Complex Figure copy test and action selectioninhibition 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R15HD093086 | NIH | None | httpsreporternihgovquickSearch1R15HD093086 |