fNIRS-Driven Visual Feedback Training to Restore Walking After Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShengjing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1: Vital signs are stable, with no severe cardiopulmonary diseases, making the patient suitable for exercise testing.
Disqualifiers
1: Patients with tumors, tuberculosis, hematological diseases, or functional impairments of vital organs such as the heart or liver.
Trial design
Design model
Parallel
Treatments tested in this trial
Intelligent Visual Feedback Motor Control Training
DevicePatients 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
DeviceBobath 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Intelligent Visual Feedback Motor Control TrainingExperimental treatment 1 intervention
Group B: Bobath Ball TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 4-weeks treatment2
Three-Dimensional Gait
* Gait spatiotemporal parameters * Lower limb joint angles * Lower limb joint moments * Ground reaction forces etc.
Time frame
Baseline, 4-weeks treatmentSecondary outcomes
1
Fugl Meyer Assessment
The Fugl-Meyer Assessment (FMA) is used to evaluate the lower limb motor function and coordination of research subjects. Modified from the Brunnstrom evaluation method, this scale is divided into two parts: upper limb and lower limb motor function assessment, with only the lower limb subscale (FMA-LE) applied in this study. The FMA-LE consists of 17 items, each graded into three levels (0 points = unable to perform; 1 point = partially performed; 2 points = fully performed), with a total score ranging from 0 to 34. A higher score indicates better lower limb motor function.
Time frame
Baseline, 4-weeks treatmentSponsors and contacts
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Source ClinicalTrials.gov