Clinical trial NCT07014891: fNIRS-Driven Visual Feedback Training to Restore 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
visual feedback
Functional near-infrared spectroscopy
walking ability
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Stroke is an injury with a high disability rate, and in recent years, it has shown a trend of younger onset. Its common complication is hemiplegia of one side of the body, which affects the walking stability and coordination of patients and severely impairs their quality of life. Exploring treatment measures that can improve the walking function of stroke patients is of great significance. Clinical studies have found that the decline in knee joint control ability in hemiplegic patients is a key problem leading to the decline in walking function. Traditional training mostly uses manual operations by therapists, with limited effects. Moreover, the single - rehabilitation treatment takes a long time and has a high training intensity, resulting in most patients developing negative emotions such as irritability and anger during the training process, and having poor compliance with rehabilitation training.

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.

Eligibility 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.

Primary outcomes:
measure: Functional near-infrared spectroscopy
timeFrame: Baseline, 4-weeks treatment
measure: Three-Dimensional Gait
timeFrame: Baseline, 4-weeks treatment
Secondary outcomes:
measure: Fugl Meyer Assessment
timeFrame: Baseline, 4-weeks treatment
measure: Berg balance scale
timeFrame: Baseline, 4-weeks treatment
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Rehabilitation Center of Shengjing Hospital, China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Xue Jiang
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
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citation: 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.