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To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.
Protocol:
Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
Study design: controlled trial with stratified randomization
Blinding
Measurements.
Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention.
Clinical assessments.
These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real rTMS | Experimental | Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins. |
|
| sham rTMS | Sham Comparator | the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) | Up to 3 months after interventions completed |
| Measure | Description | Time Frame |
|---|---|---|
| the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) | up to 3 months after the intervention completed | |
| The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) | up to 3 months after the interventions completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yen-Nung Lin, MD, MS | Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuang Ho Hospital | New Taipei City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25679340 | Derived | Lin YN, Hu CJ, Chi JY, Lin LF, Yen TH, Lin YK, Liou TH. Effects of repetitive transcranial magnetic stimulation of the unaffected hemisphere leg motor area in patients with subacute stroke and substantial leg impairment: A pilot study. J Rehabil Med. 2015 Apr;47(4):305-10. doi: 10.2340/16501977-1943. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Barthel Index (BI) | Up to 3 months after interventions completed |
| Postural control was assessed by Postural Assessment Scale for Stroke (PASS) | PASS which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. This instrument has been reported to have a good validity and reliability at different recovery stages after stroke, minimal floor and ceiling effect, and be sensitive to changes in severe stroke patients at early stage after stroke. | up to 3 months after the intervention completed |
| modified Rankin Scale (MRS) | Up to 3 months after interventions completed |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |