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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Ischemic or hemorrhagic stroke - Aged between 21 and 80 years - Not receiving botulinum toxin on the impaired arm within 3 months - MAS ≤ 3 around elbow and shoulder

Exclusion Criteria

  • have an orthopedic disorder involving upper limbs; - cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol (Montreal Cognitive Assessment (MoCA) score =< 26); - a history of another neurologic disease; - anesthesia of joint position sense in upper limbs; - are pregnant or have a chance that they might be (self-reported);

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is an early-phase clinical trial where behavioral intervention through human-machine interaction will be performed on stroke survivors.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Neuromuscular coordination-guided rehabilitative training
    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.
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.
  • Other: Force strengthening-guided rehabilitative training
    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.

Recruiting Locations

University of Houston
Houston, Texas 77045
Contact:
JIN-SOOK ROH, PhD
6173680050
jsroh@central.uh.edu

More Details

Status
Recruiting
Sponsor
University of Houston

Study Contact

Jinsook Roh, PhD
7137432578
jroh@Central.UH.EDU

Detailed Description

Stroke is the leading cause of severe long-term disability, affecting 9.4 million Americans. Each year around 800,000 people suffer a stroke even in the USA. Chronic upper extremity motor impairment is a major contributing factor to disability; functional use of the affected UE in daily life is a key factor for increased independence, return to work, and overall quality of life. Thus, effective and innovative treatment to address long-term disability is both a major public health need and an economic necessity. The study will develop an innovative human-machine interaction platform to target and improve inter-joint coordination and motor function by enhancing muscular coordination in the UE. This study, in total, 38 chronic stroke survivors will be randomly assigned into two rehabilitation strategies either neuromuscular-coordination guided exercise (NICE; therapy group) or force-guided exercise (control group). The inclusion criteria primarily consist of: (1) having experienced an ischemic or hemorrhagic stroke at least 6 months prior (chronic stroke); (2) being between 21 and 80 years of age; (3) not having received botulinum toxin treatment in the affected arm within the past 3 months; and (4) having no cognitive impairments that would affect task comprehension or the ability to provide informed consent. This study will evaluate the effects of both rehabilitation exercises on muscle coordination, standardized clinical scores, kinetics, and electroencephalogram.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.