fNIRS-Driven Visual Feedback Training to Restore Walking After Stroke

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Functional near-infrared spectroscopy — Baseline, 4-weeks treatment
  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.
• Three-Dimensional Gait — Baseline, 4-weeks treatment
  * Gait spatiotemporal parameters * Lower limb joint angles * Lower limb joint moments * Ground reaction forces etc.

Trial sites (1)

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