Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

fNIRS-guided visual feedback training to improve walking after stroke

Official title: A Study on Visual Feedback Motor Control Training Using Near-Infrared Spectroscopy (fNIRS) Brain Functional Imaging for Walking Function Recovery in Stroke Patients

Run by Shengjing Hospital · NCT07014891 · Data updated 2026-11-12

This project will test whether a brain-imaging-guided visual feedback program helps people with one-sided weakness after a recent stroke walk better than usual rehabilitation.

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment44 (estimated)
SponsorShengjing Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Shenyang, Liaoning)
StatusRecruiting
StartedDecember 15, 2024
Main results expectedDecember 3, 2025
Study endsDecember 3, 2025
Registry record updatedJune 24, 2025
Trial IDNCT07014891 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 with a first unilateral stroke within the past 6 months, Brunnstrom lower-limb stage 3–5, quadriceps strength ≥ grade 3, lower-limb spasticity < grade 2, Hoffer walking scale ≥ 2, stable vital signs, and the ability to understand and participate are ideal candidates.

Probably not a fit

Patients with severe cardiopulmonary or other vital-organ disease, active malignancy or infection, severe cognitive or language impairment, very low limb strength or high spasticity, or those beyond six months post-stroke are unlikely to receive benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with hemiplegic stroke will be randomly assigned to receive either an intelligent visual-feedback lower-limb motor control program using the MRS-FS system or conventional Bobath ball training. Therapies are delivered at Shengjing Hospital's rehabilitation center with task-oriented, gamified exercises designed to improve knee control and overall lower-limb coordination. Three-dimensional gait analysis will provide precise quantitative measures of walking mechanics, while functional near-infrared spectroscopy (fNIRS) will measure cortical activation and functional connectivity before and after the intervention. Outcomes will compare changes in walking function and analyze correlations between fNIRS signals and gait improvements.

Why it matters

Potential benefit: If successful, this approach could speed recovery of walking, improve gait symmetry, and increase independence for people after hemiplegic stroke.

How similar studies have gone: Previous trials of gamified visual-feedback and task-oriented lower-limb training have shown improvements in gait and patient engagement, but using fNIRS to guide training and link brain activation to walking gains is a relatively novel approach with limited prior data.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 1: Vital signs are stable, with no severe cardiopulmonary diseases, making the patient suitable for exercise testing.

  2: All patients are diagnosed with stroke by head CT or MRI, with clinical manifestations of unilateral limb hemiplegia.

  3: The Brunnstrom stage of the lower limb is 3-5, quadriceps muscle strength is ≥ grade 3, modified Ashworth scale for the lower limb is \< grade 2, and Hoffer walking scale is ≥ grade 2.

  4: This is their first onset of the disease, with a disease course of ≤ 6 months, and the condition is stable.

  5: Patients have no severe cognitive impairment or sensory aphasia, can understand and actively participate in the training program, and have provided informed consent by signing the consent form for this clinical study.

  6: Age: 18-75 years old, no gender restrictions.

Exclusion Criteria:

* 1: Patients with tumors, tuberculosis, hematological diseases, or functional impairments of vital organs such as the heart or liver.

  2: Those with lower limb musculoskeletal disorders, such as knee arthritis or lower limb fractures.

  3: Individuals with severe abnormal muscle tone in the limbs or joint contracture deformities.

  4: Patients experiencing severe pain that prevents them from tolerating physical activity.

  5: Special populations, such as individuals with mental illnesses, breastfeeding women, or pregnant women.

Where it's running

  • Rehabilitation Center of Shengjing Hospital, China Medical University
    Shenyang, Liaoning, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.