Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
1 other identifier
interventional
45
1 country
1
Brief Summary
Comparative Efficacy of Different Time Interval between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedDecember 23, 2022
December 1, 2022
1.9 years
December 9, 2022
December 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Assessment (FMA)
Fugl-Meyer Assessment (FMA) of upper limb
12 weeks
Secondary Outcomes (7)
Medical Research Council (MRC) scale
12 weeks
Grip strength
12 weeks
Barthel Index
12 weeks
Modified Rankin Scale
12 weeks
maximal motor evoked potential amplitude
12 weeks
- +2 more secondary outcomes
Study Arms (3)
immediate rehabilitation group
EXPERIMENTALrTMS plus immediate rehabilitation programs
delayed rehabilitation group
EXPERIMENTALrTMS plus delayed rehabilitation programs
sham rTMS group
SHAM COMPARATORsham rTMS + rehabilitation programs
Interventions
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus immediate rehabilitation programs
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus delayed rehabilitation programs (\>2hr)
Eligibility Criteria
You may qualify if:
- \>=20 years old, unilateral stroke diagnosed by CT or MRI
- Post-stroke 1 week to 6 months
- Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- No history of previous stroke, seizure, dementia, parkinsonism or other neurodegenerative disease
- stable medical condition and vital signs
You may not qualify if:
- Previous stroke, traumatic brain injury, brain tumor
- With central nervous system disease (spinal cord injury, Parkinson's disease)
- Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker, Pregnancy...)
- Patients unable to cooperate the treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheng-Hao Cheng, MD
The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2022
First Posted
December 23, 2022
Study Start
January 1, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
December 23, 2022
Record last verified: 2022-12