Method for researching influence mechanism of TBMT on upper limb recovery of stroke patient

Abstract

The invention discloses a method for researching an influence mechanism of TBMT on upper limb recovery of a stroke patient, and relates to the technical field of neurological rehabilitation and biomedical engineering. The system is realized based on a multi-modal evaluation system, and the system comprises a task-oriented mirror image therapeutic instrument which is used for guiding a patient to carry out specific hand task training; the near infrared spectrum detection module is used for collecting blood oxygen signals of the cerebral cortex of the patient in a resting state and a task state so as to evaluate the brain function connection strength and the brain region activation level; and the surface electromyographic signal acquisition module is used for acquiring electromyographic signals of related muscles when the patient executes the grasping action. The TBMT is deeply combined with the resting state / task state of the fNIRS and the sEMG, and the biological basis of the curative effect of the TBMT is clearly and objectively revealed from two dimensions of central nervous remodeling and peripheral function output; quantitative physiological signals are used for replacing or supplementing a subjective scale, so that curative effect evaluation is more accurate and sensitive, and early-stage and subtle rehabilitation progress can be found.

Description

Technical Field

[0001] This invention relates to the fields of neurorehabilitation and biomedical engineering technology, and in particular to a research method for studying the mechanism of TBMT's influence on the upper limb recovery of stroke patients. Background Technology

[0002] Stroke is a leading cause of long-term disability in adults, with upper limb paralysis, particularly hand dysfunction, posing a significant obstacle to patients' reintegration into society and independent living. While mirror therapy (MT) has been shown to be effective in restoring motor function after stroke, traditional MT has the following drawbacks: ① The treatment process is highly subjective and lacks objective and quantitative efficacy evaluation indicators; ②The central and peripheral nerve mechanisms by which it takes effect are not yet clear, which makes it impossible to precisely optimize the treatment plan; ③ The failure to deeply integrate task-oriented training with multi-sensory integration (visual and proprioceptive) limited its rehabilitation efficiency.

[0003] While some existing technologies incorporate electromyography (EMG) or electroencephalography (EEG) for biofeedback, they lack a systematic approach that integrates fNIRS, sEMG, and clinical assessment to form a comprehensive research paradigm encompassing brain-muscle and function-mechanism integration. Therefore, a research methodology capable of scientifically revealing the multimodal mechanisms underlying the efficacy of TBMT is urgently needed. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies by proposing a research method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: A research method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients, based on a multimodal assessment system, the system comprising: Task-oriented mirror therapy devices are used to guide patients in specific hand tasks. The near-infrared spectroscopy detection module is used to acquire blood oxygenation signals from the patient's cerebral cortex in both resting and task states to assess the strength of brain functional connectivity and the level of brain region activation. The surface electromyography (EMG) signal acquisition module is used to acquire EMG signals of relevant muscles when the patient performs grasping actions in order to assess muscle strength and nerve recruitment ability. An automated clinical assessment module is used for standardized entry and analysis of data from motor function scales and daily living ability scales; The central processing unit is used to synchronously receive, store, and compare and analyze data from various modules.

[0006] Preferably, the evaluation of the near-infrared spectroscopy detection module includes: Whole-brain functional connectivity analysis in the resting state, and brain region activation analysis for at least one of the following actions in the task state: grasping, wrist flexion and extension, and forearm pronation and supination.

[0007] Preferably, the task-oriented mirror therapy device integrates at least one mechanical sensor or motion capture sensor to quantify and record the physical parameters of the patient when performing the task; the central processing unit automatically adjusts the difficulty level of the training task based on the physical parameters and / or real-time physiological signals from the near-infrared spectroscopy detection module and the surface electromyography signal acquisition module through a preset algorithm to achieve personalized adaptive training.

[0008] Preferably, the system further includes a synchronization signal generator, which sends a unified timestamp signal to the central processing unit, the near-infrared spectroscopy detection module, and the surface electromyography signal acquisition module to ensure that the task event time points recorded by the mirror therapy device, the acquired blood oxygen signal time series, and the acquired electromyography signal time series are synchronized, thereby ensuring the accurate alignment and analysis of task, brain, and muscle data on the time axis.

[0009] Preferably, the method includes the following steps: S1: Subject grouping and baseline assessment; S2: Differentiated intervention; S3: Post-intervention assessment; S4: Mechanism Comparative Analysis.

[0010] Preferably, in S1, the subject grouping and baseline assessment are as follows: Patients with post-stroke hand dysfunction who met the inclusion criteria were randomly divided into an experimental group and a control group. Before the intervention, baseline data were collected from both groups using a multimodal assessment system to ensure that there was no significant difference in baseline levels between the two groups.

[0011] Preferably, in S2, the differentiated intervention is as follows: The experimental group received a combination of interventions: 20 minutes of task-oriented occupational training and 20 minutes of TBMT training based on a mirror therapy device daily; The control group received a control intervention: 40 minutes of task-oriented work training per day; Both interventions maintained the same frequency and total duration, 5 days a week for 4 weeks.

[0012] Preferably, in S3, the post-intervention assessment is as follows: After the 4-week intervention, the multimodal assessment system was used again to collect data from both groups of patients in the same way as at baseline.

[0013] Preferably, in S4, the mechanism comparison analysis is as follows: The post-intervention data of the experimental and control groups were compared with their baseline data, and the degree of improvement between the two groups was compared. The analysis included: Brain network mechanism analysis: Comparing the resting-state fNIRS data of the two groups, if the improvement in brain functional connectivity strength in the experimental group was significantly better than that in the control group, it indicates that TBMT has a mechanism to promote brain network reorganization and optimization. Brain activation mechanism analysis: Comparing the task-state fNIRS data of the two groups, if the activation level of the relevant brain regions in the experimental group was significantly better than that in the control group when performing specific hand tasks, it indicates that TBMT has a mechanism to enhance the cortical motor planning and execution ability. Peripheral muscle mechanism analysis: Comparing the sEMG data of the two groups, if the experimental group showed a significantly greater increase in electromyographic amplitude during grasping movements than the control group, it indicates that TBMT has a mechanism to improve motor unit recruitment. Clinical function correlation analysis: Correlation analysis was conducted between changes in multimodal indicators and improvements in clinical scales to verify the consistency between neurophysiological improvement and clinical function recovery.

[0014] The beneficial effects of this invention are as follows: 1. This invention deeply integrates TBMT with fNIRS resting / task-based and sEMG, clearly and objectively revealing the biological basis of its therapeutic effect from two dimensions: central nervous system remodeling and peripheral functional output. It uses quantitative physiological signals to replace or supplement subjective scales, making the efficacy assessment more accurate and sensitive, and enabling the detection of early and subtle rehabilitation progress.

[0015] 2. Through RCT design and multimodal data comparison, this invention can strongly demonstrate the specific efficacy of TBMT, providing high-level evidence-based medicine for the promotion and application of this therapy in clinical practice.

[0016] 3. The experimental results of this invention show that the research method of this invention can effectively capture the specific neurophysiological improvement brought about by TBMT, and confirm its unique mechanism in enhancing brain connectivity, improving brain activation and muscle function. Moreover, these improvements are significantly correlated with the improvement of patients' clinical scores such as FMA and MBI. Attached Figure Description

[0017] Figure 1 This is a flowchart of the research method of the present invention; Figure 2 This is a comparison of the results before and after the resting-state intervention of fNIRS in this invention; Figure 3 This is a comparison diagram of the resting-state brain functional connectivity strength before and after intervention in this invention; Figure 4 This is a statistical diagram showing the difference in brain region activation before and after the fNIRS task-based intervention of this invention; Figure 5 This is a waveform diagram comparing blood oxygen content before and after the fNIRS task-based intervention of this invention; Figure 6 This is a data graph showing the improvement in patients' motor function and daily living abilities according to the present invention. Detailed Implementation

[0018] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0019] Example 1: A 4-week randomized controlled preliminary study was conducted, such as... Figure 1 As shown, the details are as follows: 1. Study Subjects and Baseline Assessment Inclusion criteria: Forty patients with cerebral infarction or cerebral hemorrhage whose onset was within 3 months were recruited, all of whom had clear hand dysfunction (Fugl-Meyer upper limb score <50). All patients signed informed consent forms.

[0020] Randomization: Patients were randomly assigned to the experimental group (n=20) and the control group (n=20) using a block randomization method. There were no statistically significant differences between the two groups in terms of age, sex, disease duration, stroke type, and baseline assessment indicators (P>0.05), making them comparable.

[0021] Baseline data acquisition: The first multimodal assessment of all patients was completed within one week prior to the start of the intervention. Clinical scales: FMA, Brunnstrom staging, and MBI assessments were performed by a therapist whose grouping was unknown.

[0022] fNIRS testing: The patient sits in a quiet environment and wears an fNIRS probe cap. First, 8 minutes of resting-state data are collected. Then, guided by voice prompts, the patient performs three tasks: "grasp and relax," "wrist flexion and extension," and "forearm pronation and supination." Each task is performed for 60 seconds, followed by a 30-second rest, repeated twice. The system records cerebral oxygenation signals throughout the process.

[0023] sEMG detection: While the patient was performing a standard grasping action (grasping a standard grip dynamometer and maintaining 50% of the maximum voluntary contraction force for 3 seconds), the surface electromyographic signals of the extensor digitorum and flexor carpi radialis muscles were collected simultaneously.

[0024] 2. Implementation of the intervention program Experimental group: 40 minutes of training daily. First, 20 minutes of routine task-oriented occupational therapy (TOT) was conducted (e.g., picking up beans, solving puzzles, drinking water training). This was followed by 20 minutes of TBMT training: the patient placed their unaffected hand on the visible side of the mirror therapy device, and their affected hand behind the mirror. The patient viewed the image of their unaffected hand in the mirror (creating the illusion of the affected hand being active) and followed instructions to perform tasks such as "pinching a dynamometer," "pouring water from a cup," and "touching a keyboard with the index finger." The therapist adjusted the task difficulty in real time based on the patient's performance.

[0025] Control group: 40 minutes of task-oriented occupational therapy daily, with the same content as the experimental group for the first 20 minutes, but without any form of mirror therapy.

[0026] Both groups of patients received necessary routine rehabilitation treatments (such as physical therapy, acupuncture, etc.). All interventions were performed by experienced therapists, 5 days a week, for 4 weeks, for a total of 20 sessions.

[0027] 3. Post-intervention assessment and data analysis Within 48 hours after the last day of intervention, all patients underwent the same multimodal assessment as at baseline.

[0028] Data analysis methods: Statistical analysis was performed using SPSS 26.0 software. Quantitative data are expressed as mean ± standard deviation.

[0029] Within-group comparison: Paired-samples t-test was used to examine the differences in various indicators before and after intervention in the two groups of patients.

[0030] Intergroup comparison: For the improvement value (post-test - pre-test), an independent samples t-test was used to compare the differences between the experimental group and the control group.

[0031] A p-value < 0.05 was considered statistically significant.

[0032] Example of results: like Figures 2-6 ; Brain functional connectivity (resting-state fNIRS): After intervention, the experimental group showed a significant increase in the strength of functional connectivity within the brain's sensorimotor networks (such as between the left M1 area and the SMA, and between the M1 areas of the left and right hemispheres) (the connectivity lines changed from blue / light purple at baseline to purple / red after intervention), while the control group showed no significant change. This indicates that TBMT promotes the improvement of the efficiency of information exchange within the brain.

[0033] Brain region activation (task-based fNIRS): During the grasping task, the experimental group showed significantly higher activation volume and intensity in the contralateral primary motor cortex after intervention than before intervention (manifested as a significant increase in red areas), while the control group showed no such change. This indicates that TBMT specifically enhances the output ability of motor commands.

[0034] Electromyography (sEMG): In the experimental group, the mean sEMG amplitude during grasping significantly increased from (10.56±2.11) μV at baseline to (16.43±3.05) μV (P<0.01), and the maximum amplitude also significantly increased. No significant changes were observed in the control group. This indicates that TBMT improves the recruitment capacity of spinal cord α-motor neurons and the level of muscle synergistic contraction.

[0035] Trends in blood oxygenation levels: In the experimental group, the concentration of oxyhemoglobin (HbO) under task conditions generally increased after intervention (solid line) compared to baseline (dashed line), indicating enhanced neural activity; while the HbO concentration in the control group decreased slightly. This further confirms the positive effect of TBMT on brain activation from a blood oxygen dynamics perspective.

[0036] This embodiment, through the system and method described above, not only verified the clinical effectiveness of TBMT in upper limb function recovery, but more importantly, through objective evidence provided by fNIRS and sEMG, clearly revealed its multimodal mechanism of action: that is, by enhancing brain functional connectivity and task-specific activation, it improves the function of motor nerve conduction pathways, and ultimately achieves the recovery of peripheral motor function.

[0037] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients, characterized in that, This is implemented based on a multimodal evaluation system, which includes: Task-oriented mirror therapy devices are used to guide patients in specific hand tasks. The near-infrared spectroscopy detection module is used to acquire blood oxygenation signals from the patient's cerebral cortex in both resting and task states to assess the strength of brain functional connectivity and the level of brain region activation. The surface electromyography (EMG) signal acquisition module is used to acquire EMG signals of relevant muscles when the patient performs grasping actions in order to assess muscle strength and nerve recruitment ability. An automated clinical assessment module is used for standardized entry and analysis of data from motor function scales and daily living ability scales; The central processing unit is used to synchronously receive, store, and compare and analyze data from various modules.

2. The method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 1, characterized in that, The evaluation of the near-infrared spectroscopy detection module includes: Whole-brain functional connectivity analysis in the resting state, and brain region activation analysis for at least one of the following actions in the task state: grasping, wrist flexion and extension, and forearm pronation and supination.

3. The method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 2, characterized in that, The task-oriented mirror therapy device integrates at least one mechanical sensor or motion capture sensor to quantify and record the physical parameters of the patient when performing the task; the central processing unit automatically adjusts the difficulty level of the training task based on the physical parameters and / or real-time physiological signals from the near-infrared spectroscopy detection module and the surface electromyography signal acquisition module through a preset algorithm.

4. The method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 3, characterized in that, The system also includes a synchronization signal generator, which sends a unified timestamp signal to the central processing unit, the near-infrared spectroscopy detection module, and the surface electromyography signal acquisition module to ensure that the task event time points recorded by the mirror therapy device, the time series of blood oxygenation signals acquired, and the time series of electromyography signals acquired are synchronized.

5. The method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 1, characterized in that, The method includes the following steps: S1: Subject grouping and baseline assessment; S2: Differentiated intervention; S3: Post-intervention assessment; S4: Mechanism Comparative Analysis.

6. A method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 5, characterized in that, In S1, the subject grouping and baseline assessment are as follows: Patients with post-stroke hand dysfunction who met the inclusion criteria were randomly assigned to an experimental group and a control group. Baseline data were collected from both groups before the intervention using a multimodal assessment system.

7. A method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 6, characterized in that, In S2, the differentiated intervention is specifically as follows: The experimental group received a combination of interventions: daily task-oriented job training and TBMT training based on a mirror therapy device; The control group received a controlled intervention: daily task-oriented homework training; The intervention frequency and total duration were kept consistent for both groups.

8. A method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 7, characterized in that, In S3, the post-intervention assessment is specifically as follows: After the intervention, the multimodal assessment system was used again to collect data from both groups of patients in the same way as at baseline.

9. A method for studying the mechanism of TBMT's influence on upper limb recovery in stroke patients according to claim 8, characterized in that, The mechanism comparison analysis in S4 is as follows: The post-intervention data of the experimental and control groups were compared with their baseline data, and the degree of improvement between the two groups was compared. The analysis included: Brain network mechanism analysis: Comparison of two sets of resting-state fNIRS data; Brain activation mechanism analysis: Comparison of two sets of task-state fNIRS data; Peripheral muscle mechanism analysis: Comparison of sEMG data from two groups; Clinical function correlation analysis: Correlation analysis was conducted between changes in multimodal indicators and improvements in clinical scales to verify the consistency between neurophysiological improvement and clinical function recovery.

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