fNIRS-Driven Visual Feedback Training to Restore Walking After Stroke

NCT07014891 | Recruiting

• 1 other identifier: 2024PS1843K
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to investigate whether intelligent visual feedback-based lower limb motor control training is more effective than conventional rehabilitation training in promoting walking ability recovery among stroke patients with hemiplegia. The trial aims to address the primary question of the impact of intelligent visual feedback motor control training on the walking function of stroke patients with hemiplegia, and uses three-dimensional gait analysis for precise quantitative evaluation of therapeutic effects. Functional near-infrared spectroscopy (fNIRS) will be employed to explore patients' cerebral functional connectivity and cortical activation, and to analyze the correlation between fNIRS data and walking function scores (such as those from three-dimensional gait analysis), providing effective methods and a reliable reference basis for rehabilitation training of post-stroke hemiplegic patients. Participants will be randomly divided into two groups: the experimental group receiving intelligent visual feedback motor control training, and the control group receiving Bobath ball training, 20 minutes per day, 5 days per week, for a total of four weeks. Before and after the treatment, indicators including fNIRS brain functional imaging, three-dimensional gait analysis, and Fugl-Meyer Assessment will be evaluated.

Conditions

Stroke

Keywords

stroke; visual feedback; Functional near-infrared spectroscopy; walking ability

Outcome Measures

Primary Outcomes (2)

• Functional near-infrared spectroscopy

  Near-infrared Brain Functional Imaging：The testing areas cover the bilateral prefrontal lobes, motor areas, occipital lobes, and other brain regions. Within 1 week before treatment initiation, a physician will collect resting-state and task-state fNIRS data from enrolled patients.Resting-State Data Collection：The patient is fitted with an fNIRS measurement headcap. In a quiet, comfortable environment, they are instructed to sit, relax, keep eyes closed (without falling asleep), and data are collected for 5 minutes.Task-State Data Collection：A walking paradigm is set up. The test includes a 10-second preparatory phase where the patient stands at rest, followed by the task phase:Upon the command "Please start walking," the subject alternates stepping for 30 seconds.At the command "Stop," they cease walking and stand in place to rest for 30 seconds. This "walk-rest" cycle is repeated 4 times.Identical data collection will be completed within 1 week after treatment concludes.

  Baseline, 4-weeks treatment

• Three-Dimensional Gait

  * Gait spatiotemporal parameters * Lower limb joint angles * Lower limb joint moments * Ground reaction forces etc.

  Baseline, 4-weeks treatment

Secondary Outcomes (1)

• Fugl Meyer Assessment

  Baseline, 4-weeks treatment

Study Arms (2)

Intelligent Visual Feedback Motor Control Training

EXPERIMENTAL

Patients receive motor control training using the Intelligent Visual Feedback Motor Control Training System (Monitored Rehab Systems B.V., 2031 CW Haarlem, The Netherlands), with the Monitored Rehab Systems-Functional Squat selected for training. The patient is in a supine position, with both feet fixed at the correct position on the pushing training board. The relative position of the patient is displayed on the computer screen. The system uses the height, length, and size of images to represent the degree of joint flexion/extension and the duration of muscle contraction, while the speed of moving images reflects the speed of joint movement and muscle contraction during exercise. Patients complete various simulated actions through interactive video games. The load of exercise training can be adjusted according to the patient's functional status and tolerance. The training is conducted once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks.

Device: Intelligent Visual Feedback Motor Control Training

Bobath Ball Training

ACTIVE COMPARATOR

Bobath Ball Training Specific operations include: ① In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform stepping movements, etc. The training is conducted 1 session daily, 20 minutes per session, 5 days per week, for a total of 4 weeks.

Device: Bobath Ball Training

Interventions

Intelligent Visual Feedback Motor Control Training DEVICE

Patients receive motor control training using the intelligent training system (Monitored Rehab Systems B.V., 2031 CW Haarlem, The Netherlands). The Monitored Rehab Systems-Functional Squat is selected for lower - limb motor control training. The patient assumes a supine position, with both feet fixed at the correct position on the pushing - training board. The relative position of the patient can be displayed on the computer screen. The system represents the degree of joint flexion and extension and the duration of muscle contraction through the height, length, and size of images, while the speed of moving images reflects the speed of joint movement during exercise. Patients complete various simulated actions through interactive video games. During the training, the load of exercise training can be adjusted according to the patient's functional status and tolerance. The training is conducted once a day, 20 minutes per session, five times a week, for a total of four weeks.

Intelligent Visual Feedback Motor Control Training

Bobath Ball Training DEVICE

Bobath Ball Training Specific operations include: ① In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform stepping movements, etc. The training is conducted 1 session daily, 20 minutes per session, 5 days per week, for a total of 4 weeks.

Bobath Ball Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Vital signs are stable, with no severe cardiopulmonary diseases, making the patient suitable for exercise testing.
• : All patients are diagnosed with stroke by head CT or MRI, with clinical manifestations of unilateral limb hemiplegia.
• : 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.
• : This is their first onset of the disease, with a disease course of ≤ 6 months, and the condition is stable.
• : 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.
• : Age: 18-75 years old, no gender restrictions.

You may not qualify if:

• : Patients with tumors, tuberculosis, hematological diseases, or functional impairments of vital organs such as the heart or liver.
• : Those with lower limb musculoskeletal disorders, such as knee arthritis or lower limb fractures.
• : Individuals with severe abnormal muscle tone in the limbs or joint contracture deformities.
• : Patients experiencing severe pain that prevents them from tolerating physical activity.
• : Special populations, such as individuals with mental illnesses, breastfeeding women, or pregnant women.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Rehabilitation Center of Shengjing Hospital, China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

Related Publications (6)

• Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.

  PMID: 22510258 RESULT

• Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, Sung WH. Effects of Computer-Aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control following Chronic Stroke: A Randomized Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0131048. doi: 10.1371/journal.pone.0131048. eCollection 2015.

  PMID: 26193492 RESULT

• Takahashi MTC, Balardin JB, Bazan PR, Boasquevisque DS, Amaro Junior E, Conforto AB. Effect of transcranial direct current stimulation in the initial weeks post-stroke: a pilot randomized study. Einstein (Sao Paulo). 2024 Jun 24;22:eAO0450. doi: 10.31744/einstein_journal/2024AO0450. eCollection 2024.

  PMID: 38922218 RESULT

• Cohen EJ, Quarta E, Bravi R, Granato A, Minciacchi D. Neural plasticity and network remodeling: From concepts to pathology. Neuroscience. 2017 Mar 6;344:326-345. doi: 10.1016/j.neuroscience.2016.12.048. Epub 2017 Jan 7.

  PMID: 28069532 RESULT

• Schnautz LS. Critical Care Nursing Clinics of North America. Cardiovascular disease in women. Preface. Crit Care Nurs Clin North Am. 2008 Sep;20(3):xi-xii. doi: 10.1016/j.ccell.2008.03.015. No abstract available.

  PMID: 18644505 RESULT

• Jarvis HL, Brown SJ, Price M, Butterworth C, Groenevelt R, Jackson K, Walker L, Rees N, Clayton A, Reeves ND. Return to Employment After Stroke in Young Adults: How Important Is the Speed and Energy Cost of Walking? Stroke. 2019 Nov;50(11):3198-3204. doi: 10.1161/STROKEAHA.119.025614. Epub 2019 Sep 26.

  PMID: 31554503 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xue Jiang

  Shengjing Hospital

  STUDY CHAIR

Central Study Contacts

Xue Jiang

CONTACT

+8618940254064; jiangxueruby@163.com

Yan Chi

CONTACT

+8615241806025; chiyan0726@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: December 15, 2024
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication under reasonable request.

Locations

CN (1)