A Study on Visual Feedback Motor Control Training Using Near-Infrared Spectroscopy (fNIRS) Brain Functional Imaging for Walking Function Recovery in Stroke Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Rehabilitation Center of Shengjing Hospital, China Medical University
RECRUITING
Shenyang
Contact Information
Primary
Xue Jiang
jiangxueruby@163.com
+8618940254064
Backup
Yan Chi
chiyan0726@163.com
+8615241806025
Time Frame
Start Date: 2024-12-15
Estimated Completion Date: 2025-12-03
Participants
Target number of participants: 44
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: Shengjing Hospital

This content was sourced from clinicaltrials.gov