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This study is aimed to investigate the effect of continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) on upper extremity spasticity and functional recovery in patients with chronic ischemic stroke.
A sham-controlled double-blind randomized study was undertaken. 20 patients with chronic stroke were randomized into active rTMS group (n=7), active cTBS group (n=7) and sham cTBS group (n=6). In the active rTMS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In the active cTBS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. Sham cTBS was applied in the same protocol but using sham coil. Within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities under the guidance of a physiotherapist, regardless of which group they were in. Upper Extremity Fugl-Meyer Motor Function Scale, Modified Ashworth Scale (MAS), Functional Independence Measure (FIM), Motor Activity Log-28 (MAL-28) and Brunnstrom upper extremity and hand motor recovery stage were assessed at pre-treatment, post-treatment and follow up at 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS group | Active Comparator | chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy |
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| Active cTBS group | Active Comparator | chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy |
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| Sham cTBS group | Sham Comparator | chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Repetitive Transcranial Magnetic Stimulation Therapy | Device | 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Fugl-Meyer Motor Function Scale | Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome. | up to 6 weeks |
| Modified Ashworth Scale | Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome. | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure | Scale measures level of independence on activities of daily life (min-max: 18-126 points). Self-care part of the motor subscale was used in this study (min-max:6-42 points). Higher values represent a better outcome. | up to 6 weeks |
| Motor Activity Log-28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bilge Yılmaz, Professor,MD | Gaziler PMR, Training and Research Hospital, Department of PMR | Study Director |
| Ömer Kuzu, MD | Gaziler PMR, Training and Research Hospital, Department of PMR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziler PMR, Training and Research Hospital, Department of PMR | Ankara | Çankaya | 06100 | Turkey (Türkiye) |
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| Active Continuous Theta Burst Stimulation Therapy | Device | 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities. |
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| Sham Continuous Theta Burst Stimulation Therapy | Device | 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and sham cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities. |
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Scale measures frequency of use and functionality level of the affected upper limb during daily activities (min-max: 0-5 points). Higher values represent a better outcome. |
| up to 6 weeks |
| Brunnstrom Motor Recovery Scale | Scale measures upper extremity and hand motor recovery stages (min-max: 1-6). Higher values represent a better outcome. | up to 6 weeks |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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