stroke
Conditions
Interventions
Study 1: Task-oriented soft robot glove training +rTMS group:Age-matched healthy subjects were treated with soft robot glove therapy and rTMS therapy in sequence.
Study 1: TMS+Task-oriented soft robot glove training group:Age-matched healthy subjects were treated with rTMS and soft robotic gloves sequentially.
Study 1: rTMS +Task-oriented soft robot glove training group:Stroke patients who met the inclusion and exclusion criteria were treated with rTMS and soft robotic gloves in sequence.
Study 1: Task-oriented soft robot glove training +rTMS group:Stroke patients who met the inclusion and exclusion criteria were treated with soft robotic gloves rTMS in sequence.
Study 2: Combination treatment group:rTMS and soft robotic gloves in sequence according to results of study I.
Study 2: rTMS treatment group:rTMS treatment.
Study 2: sham rTMS+Task-oriented soft robot glove training group:sham rTMS+soft robot glove training
Sponsors
Zhongda Hospital affiliated to Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for study I: (1) Inclusion criteria for healthy subjects: ? Aged 18-75 years (inclusive); ? Edinburgh Handedness Scale was assessed as right-handedness; ? Good health condition, no cerebrovascular disease, no brain and spinal cord injury, no neuromuscular disease or injury, no tinnitus, insomnia and other symptoms; ? Agree to participate in the experiment and sign the informed consent; (2) Inclusion criteria for stroke patients: ? Age 18-75 years old (inclusive); (2) First stroke diagnosed by computed tomography (CT) and/or MRI; (3) The course of stroke from 1 month to 6 months after onset, Brunnstrom stage II to V; ? Good cognitive function, MMSE score =21, can understand simple commands and cooperate with treatment, can tolerate 1h-1.5h test and evaluation; ? Sign informed consent. 2. Inclusion criteria for Study 2: Inclusion criteria for stroke patients: ? Age 18-75 years old (inclusive); (2) First stroke diagnosed by computed tomography (CT) and/or MRI; (3) The course of stroke from 1 month to 6 months after onset, Brunnstrom stage II to V; ? Good cognitive function, MMSE score =21, can understand simple commands and cooperate with treatment, can tolerate 1h-1.5h test and evaluation; ? Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for study 1: Exclusion criteria for healthy subjects: (1) Clinical imaging indicated finger and wrist joint lesions; ? History of epilepsy and family history of epilepsy; ? Other clinical studies are being conducted; ? Other reasons can not cooperate with the evaluation and detection. Exclusion criteria for stroke patients: ? had intracerebral implants or metal, cochlear implants, cardiac pacemakers, etc.; ? Patients with severe upper limb spasm, modified Ashworth scale > grade 2; (3) Epilepsy patients and those who take drugs that can cause epilepsy, have serious heart, liver, kidney diseases (such as myocardial infarction, heart failure, liver cancer and uremia) or infectious diseases; Participate in other clinical studies. 2. Exclusion criteria for study 2: Exclusion criteria for stroke patients: ? had intracerebral implants or metal, cochlear implants, cardiac pacemakers, etc.; ? Patients with severe upper limb spasm, modified Ashworth scale > grade 2; (3) Epilepsy patients and those who take drugs that can cause epilepsy, have serious heart, liver, kidney diseases (such as myocardial infarction, heart failure, liver cancer and uremia) or infectious diseases; Participate in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study 1: corticomuscular coupling;Study 2: Fugl-Meyer assessment for upper extremity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Study 1: Median nerve F wave;Study 1: Electrophysiological indicators (Ipsilateral silent period, motor evoked potential, MEP recruitment curve);Study 1: Nine Hole Peg Test;Study 2: corticomuscular coupling;Study 2: Upper limb motor performance (box and blocks test, Wolf Motor Function Test, Nine Hole Peg Test, Action Research Arm Test);Study 2: Muscle strength and spasticity (manual muscle test, surface electromyography, grip strength,Joint range of motion, Modified Ashworth Scale, F-wave, H/M ratio);Study 2: Brunnstrom Recovery Stages for Upper Limb?;Study 2: Cortical excitability (MEP, MEP recruitment curve, and cortical silence period);Study 2: Assessment of activities of daily living (Modified Barthel Index, Functional independence measure, Motor activity log);Study 2: Sensory evoked potential (Semmes-Weinstein monofilament test, and Nottingham Sensory Assessment);Study 2: Imaging evaluation (structural MRI, fMRI, DTI collection); | — |
Countries
China
Contacts
Public ContactWenli Chen
Zhongda Hospital of Southeast University
Outcome results
None listed