fNIRS-guided visual feedback training to improve walking after stroke
A Study on Visual Feedback Motor Control Training Using Near-Infrared Spectroscopy (fNIRS) Brain Functional Imaging for Walking Function Recovery in Stroke Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT07014891 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shenyang, Liaoning
- Rehabilitation Center of Shengjing Hospital, China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Xue Jiang
- Email: jiangxueruby@163.com
- Phone: +8618940254064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.