NCT07531264

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

Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Houston · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Stroke
• Chronic Stroke
• Hemiparetic Stroke

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-10-10
• Primary completion: 2029-08-01
• Completion: 2030-08-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States