EMG-guided Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction

Part of paid clinical trials in Houston, Texas.

Sponsor
University of Houston
Study ID
NCT07531264
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Chronic Stroke
  • Hemiparetic Stroke
  • Stroke

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Neuromuscular coordination-guided rehabilitative training — OTHER
    During training exercise, post-stroke participants will be asked to match the targets on the screen. The experimental group will match them by activating a specific set of muscle. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.
  • Force strengthening-guided rehabilitative training — OTHER
    During training exercise, post-stroke participants will be asked to match the targets on the screen. The active comparator group will match them by generating isometric force in a desired target direction. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.

Study Details

The objective of this study is to develop Neuro-Intermuscular Coordination Enhancement (NICE) rehabilitation, a novel neuromuscular control signal-guided strategy that visually guides stroke patients to individually activate groups of synergistic muscles through human-machine interaction. Ultimately, the development will lead to better clinical motor recovery, better quality of life, and lowered healthcare costs associated with the impairment.

Key Dates

Start date
Oct 10, 2023
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neuromuscular coordination-guided rehabilitative training
    Post-stroke participants will perform a center-out task by generating isometric contractions of multiple muscles to move the cursor on a screen while electromyographic (EMG) responses are recorded. Activation of each muscle (or muscle group) will be mapped to 1 of 4 directions within the multi-dimensional cursor space. We will derive the cursor position in real time using EMGs recorded from multiple arm muscles.
  • Active Comparator: Force strengthening-guided rehabilitative training
    Post-stroke participants will perform a center-out task by generating isometric force to move the cursor on a screen. Participants will generate isometric force, which will move their cursor on the monitor. They will be trained to match one of the four force targets on display. We will derive the cursor position in real time using three forces (Fx, Fy, and Fz) measured at the load cell.

Primary Outcome Measure

Change in Fugl-Meyer Assessment (FMA) score [ Time Frame: Pre-Training (baseline), post-training (6-week follow-up), 10-week and 18-week follow ups ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of HoustonHoustonTexas77045
JIN-SOOK ROH, PhD
6173680050
Jinsook Roh, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition

Related Studies