Repetitive Transcranial Magnetic Stimulation Combined With Bimanual Therapy for Upper Limb Stroke Rehabilitation

Not Applicable

Not yet recruiting

• Conditions: Post-stroke Upper Limb Hemiparesis; Repetitive Transcranial Magnetic Stimulation (rTMS); Bimanual Therapy; Neuromodulation

• Registration Number: NCT07054424
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2025-07-15
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Age 40-80 years;
2. First-onset stroke patients;
3. Patients diagnosed with cerebral infarction or hemorrhage through CT or MRI;
4. Signed informed consent form by the patient and their family;
5. Stable physiological parameters;
6. Stroke occurred within the last 12 months;
7. Patients with unilateral hand function impairment caused by the stroke;
8. Upper limb muscle tone (Modified Ashworth Scale, MAS) less than 3 points;
9. Able to follow two-step commands.

Exclusion Criteria

1. A history of epilepsy or family history of epilepsy;
2. Presence of suicidal tendencies;
3. Currently using medications that lower the seizure threshold;
4. Pregnant or planning to become pregnant;
5. Co-existing neurological diseases (such as multiple sclerosis, other neurodegenerative diseases, meningitis, brain abscess, or meningioma);
6. Subjects with uncontrollable migraines caused by elevated intracranial pressure;
7. Subjects taking antidepressants who cannot discontinue the medication;
8. Subjects with sleep disorders during rTMS treatment;
9. Subjects with cerebellar stroke or brainstem stroke;
10. Cerebral ischemic disorders resulting from traumatic brain injury;
11. Transient ischemic attacks (TIAs);
12. History of bleeding tendency and other conditions affecting upper limb function, such as myasthenia gravis, systemic immune neuropathy, severe epilepsy, endocrine system disorders, wearers of external or internal cardiac pacemakers, individuals with metallic implants or orthopedic devices;
13. Co-existing severe heart, liver, kidney dysfunction, or other serious physical illnesses;
14. Subjects with impaired consciousness who cannot cooperate with examinations or treatments, such as those with mental disorders, or those with intellectual or cognitive impairments, severe dementia;
15. Presence of implanted electronic devices in the body;
16. Co-existing severe liver, kidney, or hematological disorders;
17. Special vulnerable populations;
18. Skin disease (e.g., pressure ulcers, trauma, cellulitis, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	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.

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale (MAS)	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.
Upper Extremities Muscle Strength	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.
Action Reach Arm Test (ARAT)	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.
Brunnstrom Recovery Stage	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.
Instrumental Activities of Daily Living Scale (IADLs)	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.
System Usability Scale (SUS)	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.
Satisfaction Questionnaire	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.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou, Taoyuan 333, Taiwan; 🇨🇳 Taoyuan, Taiwan