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Development of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Machine-assisted Bimanual Therapy (BT) in Upper Limb Rehabilitation

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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;

• Stable physiological parameters;

• Stroke occurred within the last 12 months;

• Patients with unilateral hand function impairment caused by the stroke;

• Upper limb muscle tone (Modified Ashworth Scale, MAS) less than 3 points;

• Able to follow two-step commands.

Locations
Other Locations
Taiwan
Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou, Taoyuan 333, Taiwan
RECRUITING
Taoyuan
Contact Information
Primary
Yu-Cheng Pei, MD, PhD
yspeii@gmail.com
+886 3 3281200
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 54
Treatments
Sham_comparator: Control group
15 mins self-initiated stretching exercise + 50 mins conventional occupational therapy
Active_comparator: rTMS-only group
15 mins rTMS and 50 mins conventional occupational therapy
Experimental: rTMS combined with bimanual therapy group
15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov