fNIRS-Driven Visual Feedback Training to Restore Walking After Stroke
NCT ID: NCT07014891
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
44 participants
INTERVENTIONAL
2024-12-15
2025-12-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Retraining the Walking Pattern After Stroke
NCT03813342
Visual Feedback Balance Training System Combined with RFE in Stroke
NCT06477445
Gait Control of Stroke Patients Using Visual Feedback
NCT02029664
Effect of Brain-Computer Interfaced-Assisted Motor Imagery for Gait Retraining in Stroke Patients
NCT02507895
fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
NCT03559283
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The MRS - FS (Monitored Rehab Systems-Functional Squat) system is a horizontal squat weight - reduction device that simulates the human squatting motion. Patients can safely perform early lower - limb strength training in a lying - down position. The real - time electronic images presented by this system help correct abnormal postures of patients, strengthen motor control, and thus improve walking function. In addition, the gamified and task - oriented exercise training mode can evoke positive emotions, improve patients' compliance with rehabilitation training, and enhance the effectiveness of exercise training. Existing studies have confirmed that MRS - FS can effectively improve lower - limb function, provide real - time feedback, improve knee joint control ability, and correct hemiplegic gait. However, currently, there are relatively few randomized controlled trial studies in clinical applications for the rehabilitation treatment of stroke patients with hemiplegia. Therefore, the treatment plan and efficacy evaluation of this system for stroke patients with hemiplegia are the key points for further exploration in this study.
Research shows that the main mechanism of functional recovery after stroke is the plastic change of the central nervous system and the remodeling of brain function. Functional near - infrared spectroscopy (fNIRS) is a non - invasive, safe, and non - invasive imaging technique. It can accurately measure the changes in cerebral cortex activity by detecting the changes in blood oxygen levels in the cerebral cortex. Different from technologies such as X - ray and CT, fNIRS does not involve ionizing radiation. This study innovatively uses fNIRS to explore the brain functional connectivity and activation status that are affected by intelligent visual feedback motor control training on patients' walking function, and further observes the recovery of brain function. At the same time, three - dimensional gait analysis is used to accurately quantify gait characteristics, providing an effective treatment method for the rehabilitation training of stroke patients with hemiplegia.
Research process: According to the inclusion and exclusion criteria, if a patient meets the enrollment conditions of this trial and agrees to participate in this study, after signing the informed consent form, they will start to enter this study. The study period is 4 weeks. Assessments will be conducted before treatment and 4 weeks after treatment, including: near - infrared brain function imaging; three - dimensional gait analysis; Fugl - Meyer Assessment - Lower Extremity. The treatment of patients may include intelligent visual feedback motor control training / Bobath ball training. Treatment grouping: Subjects will be randomly grouped, and each subject has an equal probability of being assigned to any group. There are two groups in total: Group A: Intelligent visual feedback motor control training (MRS - FS); Group B: Bobath ball training.
1. MRS - FS: The training includes six levels: random response, isometric contraction, random burst, control path, control position, and random deceleration. During the training process, the load of exercise training can be adjusted according to the patient's functional status and tolerance. It is carried out once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks of treatment.
2. Bobath ball: Specifically, it includes: ①In 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 a stepping motion, etc. It is carried out once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks of treatment. For the randomized study: Patients may be randomly assigned (like flipping a coin) to Group A or Group B. Assessments will be carried out before treatment and 4 weeks after treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intelligent Visual Feedback Motor Control Training
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.
Intelligent Visual Feedback Motor Control Training
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.
Bobath Ball Training
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intelligent Visual Feedback Motor Control Training
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.
Bobath Ball Training
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shengjing Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xue Jiang
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xue Jiang
Role: STUDY_CHAIR
Shengjing Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rehabilitation Center of Shengjing Hospital, China Medical University
Shenyang, Liaoning, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024PS1843K
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.