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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:
Participants will be randomly assigned to different groups and will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | 15 mins self-initiated stretching exercise + 50 mins conventional occupational therapy |
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| rTMS-only group | Active Comparator | 15 mins rTMS and 50 mins conventional occupational therapy |
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| rTMS combined with bimanual therapy group | Experimental | 15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional occupation therapy | Other | Standard occupational therapy focused on improving daily functional skills through task-specific training and adaptive techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Cheng Pei, MD, PhD | Contact | +886 3 3281200 | 3846 | yspeii@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou, Taoyuan 333, Taiwan | Recruiting | Taoyuan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36742107 | Result | Kim WS, Paik NJ. Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Brain Neurorehabil. 2021 Mar 18;14(1):e6. doi: 10.12786/bn.2021.14.e6. eCollection 2021 Mar. | |
| 21221011 | Result | Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2025 | Jun 25, 2025 |
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An investigator reviewed the inclusion and exclusion criteria and assigned participants to one of the study groups. Participants were randomly allocated to either the rTMS combined with bimanual therapy group, the rTMS only group, or the control group receiving standard rehabilitation. Randomization and group assignment were performed by a research assistant using a computer-generated randomization sequence to ensure unbiased allocation. Each intervention was conducted over a 4-week period, consisting of 10 sessions, during which participants received intervention according to their assigned group.
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| stretching exercise | Other | Techniques involving passive or active stretching of muscles to enhance flexibility, reduce spasticity, and prevent contractures. |
|
| rTMS | Other | Non-invasive brain stimulation method using magnetic pulses to modulate cortical excitability and promote neural plasticity. |
|
| bimanual therapy | Device | 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 |
|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Instrumental Activities of Daily Living Scale (IADLs) | 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. | 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. |
| System Usability Scale (SUS) | 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. | Administered once immediately after the final intervention session to capture the participant's impressions of the device's usability. |
| Satisfaction Questionnaire | 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. | Administered once immediately after the final intervention session to assess participants' subjective satisfaction with the intervention. |
| 37831019 | Result | Liu C, Li L, Li B, Liu Z, Xing W, Zhu K, Jin W, Lin S, Tan W, Ren L, Zhang Q. Efficacy and Safety of Theta Burst Versus Repetitive Transcranial Magnetic Stimulation for the Treatment of Depression: A Meta-Analysis of Randomized Controlled Trials. Neuromodulation. 2024 Jun;27(4):701-710. doi: 10.1016/j.neurom.2023.08.009. Epub 2023 Oct 12. |
| 15664172 | Result | Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. |
| 35051941 | Result | Li X, Lin YL, Cunningham DA, Wolf SL, Sakaie K, Conforto AB, Machado AG, Mohan A, O'Laughlin K, Wang X, Widina M, Plow EB. Repetitive Transcranial Magnetic Stimulation of the Contralesional Dorsal Premotor Cortex for Upper Extremity Motor Improvement in Severe Stroke: Study Protocol for a Pilot Randomized Clinical Trial. Cerebrovasc Dis. 2022;51(5):557-564. doi: 10.1159/000521514. Epub 2022 Jan 20. |
| 32510515 | Result | Chen YM, Lai SS, Pei YC, Hsieh CJ, Chang WH. Development of a Novel Task-oriented Rehabilitation Program using a Bimanual Exoskeleton Robotic Hand. J Vis Exp. 2020 May 20;(159). doi: 10.3791/61057. |
| 36550934 | Result | Huang JJ, Pei YC, Chen YY, Tseng SS, Hung JW. Bilateral Sensorimotor Cortical Communication Modulated by Multiple Hand Training in Stroke Participants: A Single Training Session Pilot Study. Bioengineering (Basel). 2022 Nov 24;9(12):727. doi: 10.3390/bioengineering9120727. |
| 22344782 | Result | Chen JL, Ros T, Gruzelier JH. Dynamic changes of ICA-derived EEG functional connectivity in the resting state. Hum Brain Mapp. 2013 Apr;34(4):852-68. doi: 10.1002/hbm.21475. Epub 2012 Feb 17. |
| 7333761 | Result | Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available. |
| Result | De Weerdt WJG, Harrison MA. "Measuring recovery of arm-hand function in stroke patients: a comparison of the Brunnstrom-Fugl-Meyer test and the Action Research Arm test. Physiotherapy Canada. 1985; 37:65-70. |
| 2701823 | Result | Crow JL, Lincoln NB, Nouri FM, De Weerdt W. The effectiveness of EMG biofeedback in the treatment of arm function after stroke. Int Disabil Stud. 1989 Oct-Dec;11(4):155-60. doi: 10.3109/03790798909166667. |
| 14293031 | Result | CARROLL D. A QUANTITATIVE TEST OF UPPER EXTREMITY FUNCTION. J Chronic Dis. 1965 May;18:479-91. doi: 10.1016/0021-9681(65)90030-5. No abstract available. |
| 3160243 | Result | Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386. |
| 6932734 | Result | Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available. |
| 1135616 | Result | Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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