Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou, Taoyuan 333, Taiwan
Taoyuan, Taiwan
Location status: Recruiting
NCT Number: NCT07054424
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Not applicable
Taoyuan, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard occupational therapy focused on improving daily functional skills through task-specific training and adaptive techniques.
Techniques involving passive or active stretching of muscles to enhance flexibility, reduce spasticity, and prevent contractures.
Non-invasive brain stimulation method using magnetic pulses to modulate cortical excitability and promote neural plasticity.
A 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
Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.
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.
Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.
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.
Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.
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.
Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.
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.
Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.
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.
Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.
The IADLs assess functional independence in more complex daily tasks, including using the telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances. The scores vary by gender: for females, the full 8 items are scored (0-8); for males, traditional scoring omits food preparation, housekeeping, and laundry, resulting in a 5-point scale (0-5). Higher scores indicate greater functional independence.
Time frame: Administered once immediately after the final intervention session to capture the participant's impressions of the device's usability.
The usability of the device and intervention was evaluated using the System Usability Scale (SUS), which captures user experience from both patients and caregivers. The SUS comprises ten Likert-scale items, alternating between positive and negative statements to minimize response bias. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). The total SUS score is calculated and converted to a scale of 0 to 100, with scores above 68 generally indicating acceptable usability.
Time frame: Administered once immediately after the final intervention session to assess participants' subjective satisfaction with the intervention.
A custom satisfaction questionnaire was administered to evaluate participants' overall satisfaction with the rehabilitation process. It uses a 5-point Likert-type scale ranging from 1 (very poor) to 5 (very good) to assess domains such as comfort, perceived effectiveness, motivation, and willingness to continue. Higher scores reflect more favorable responses and higher levels of satisfaction.
Contact information is provided by the study sponsor or research team.
Chang Gung Memorial Hospital
Other
Development of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Machine-assisted Bimanual Therapy (BT) in Upper Limb Rehabilitation
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