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This study was a prospective, randomized, single-blind, parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation and transcranial direct current stimulation assisted rehabilitation in the treatment of cerebrovascular disease-related gait disorders.
This study was a prospective, randomized, single-blind, parallel-controlled, multicenter clinical study. The main purpose was to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation and transcranial direct current stimulation assisted rehabilitation in the treatment of cerebrovascular disease-related gait disorders. The secondary objective was to assess the effects of these two types of neuromodulation on cognitive, emotional, and daily living abilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Active | Active Comparator | Active rTMS for Gait Dysfunction of Hemiplegia |
|
| Group A - Sham | Sham Comparator | Sham rTMS for Gait Dysfunction of Hemiplegia |
|
| Group B - Active | Active Comparator | Active tDCS for Frontal Gait Dysfunction |
|
| Group B - Sham | Sham Comparator | Sham tDCS for Frontal Gait Dysfunction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS | Device | 4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Velocity of 10m walking test | Velocity of 10m walking test (10MWT) according to the video | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 10m walking test | Step width, step size, step frequency of 10m walking test (10MWT) according to the video | 12 weeks |
| Turn time of time up and go test | Total time, pace, standing time, turn time of time up and go test (TUGT) according to the video |
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Inclusion Criteria:
Group A: Gait Dysfunction of Hemiplegia
Group B: Frontal Gait Dysfunction
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang, MD | Contact | 02164041991 | wang.xin@zs-hospital.sh.cn | |
| Jing Ding, MD | Contact | 02164041991 | ding.jing@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xin Wang, MD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Sham rTMS | Device | 4-week (5 days per week) sham rTMS |
|
| Active tDCS | Device | 4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min) |
|
| Sham tDCS | Device | 4-week (5 days per week) sham tDCS |
|
| Walking training | Other | 4-week (5 days per week) walking training |
|
| Cognition training | Other | 4-week (5 days per week) cognition training |
|
| 12 weeks |
| Dual-task walking | Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video | 12 weeks |
| Tinetti Balance and Gait Analysis | Gait evaluation according to Tinetti Balance and Gait Analysis (Full score: 28. score >= 19 indicates high risk of fall.) | 12 weeks |
| Mini-mental state examination (MMSE) | Cognition evaluation according to Mini-mental state examination (Full score: 30. score <24 indicates cognitive impairment. ) | 12 weeks |
| Montreal cognitive assessment (MoCA) | Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score <26 indicates cognitive impairment. | 12 weeks |
| Symbol digit modalities test (SDMT) | Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. ) | 12 weeks |
| Color word test (CWT) | Execution evaluation according to Color word test (Counting number of right ones. ) | 12 weeks |
| Hamilton depression scale (HAMD) | Mood evaluation according to Hamilton depression scale (Score >7 indicates possible depression.) | 12 weeks |
| Instrumental activities of daily living (IADL) | Daily living ability evaluation according to Instrumental activities of daily living (Full score: 24. Higher score indicates higher independence. ) | 12 weeks |
| Shanghai Eighth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Huadong Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Sixth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Xuhui District Central Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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