About this trial
The goal of this clinical trial is to evaluate whether combining repetitive transcranial magnetic stimulation (rTMS) with machine-assisted bimanual therapy (BT) can improve upper limb function in stroke patients. The participants will be individuals aged 40-80 years who have experienced a first-time ischemic or hemorrhagic stroke. The main questions it aims to answer are:
* Does the combined therapy enhance motor recovery compared to traditional rehabilitation methods? * Are changes in brain activity associated with improvements in upper limb function?
Participants will be randomly assigned to different groups and will:
* Receive rTMS stimulation on specific areas of the brain to modulate neural activity, * Perform machine-assisted bimanual exercises to promote motor skills, and * Undergo assessments before, immediately after, and during follow-up periods to measure functional improvements.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40-80 years;
First-onset stroke patients;
Patients diagnosed with cerebral infarction or hemorrhage through CT or MRI;
Signed informed consent form by the patient and their family;
Disqualifiers
A history of epilepsy or family history of epilepsy;
Presence of suicidal tendencies;
Currently using medications that lower the seizure threshold;
Pregnant or planning to become pregnant;
Trial design
Parallel
Treatments tested in this trial
Conventional occupation therapy
Other interventionStandard occupational therapy focused on improving daily functional skills through task-specific training and adaptive techniques.
stretching exercise
Other interventionTechniques involving passive or active stretching of muscles to enhance flexibility, reduce spasticity, and prevent contractures.
rTMS
Other interventionNon-invasive brain stimulation method using magnetic pulses to modulate cortical excitability and promote neural plasticity.
bimanual therapy
DeviceA training approach that involves simultaneous use of both hands to enhance coordination and functional hand movements through guided exercises, including device-assisted and robot-assisted therapy
Treatment groups
Trial outcomes
Primary outcomes
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.
Secondary outcomes
Modified Ashworth Scale (MAS)
This scale is used to evaluate spasticity in muscles by assessing resistance during passive soft-tissue stretching. Scores range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with higher scores indicating greater spasticity.
Upper Extremities Muscle Strength
Manual muscle testing (MMT) is used to assess the strength of major upper limb muscle groups, including the shoulder abductors, elbow flexors/extensors, wrist extensors, and finger flexors/extensors. The scoring is based on the standard 0-5 MMT grading scale, where higher scores indicate greater muscle strength.
Action Reach Arm Test (ARAT)
The ARAT is a standardized observational assessment that evaluates upper limb function through 19 items across four domains: grasp, grip, pinch, and gross movement. The total score ranges from 0 to 57, with higher scores indicating better upper extremity function.
Brunnstrom Recovery Stage
This classification system assesses motor recovery following stroke and categorizes the patient's progress into six stages for the upper extremity, hand, and lower extremity. Stage I represents flaccidity, and Stage VI represents near-normal movement.
Sponsors and contacts
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