Clinical trial NCT03817385: rTMS and Robotic Gait Training in Patients With Stroke
Official title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) and Robotic Gait Training on Lower-extremity Function and Gait in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Transcranial magnetic stimulation
Robotic gait training
Gait
Spasticity
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with stroke have demonstrated abnormal muscle tone and postural control ability which affect their ambulation, activity of daily living and confident. Nowadays, utilizing repetitive transcranial magnetic stimulation (rTMS) and robotic machines to assist walking training for stroke patients has been applied to clinic widely. While less studies have compared intervention efficacy for stroke patients between rTMS and robotic training. This study aimed to compare effect of rTMS and robotic training for lower-extremity function and gait in stroke patients.

Detailed description: This study will include subjects occurring stroke within 3 months. All groups will receive traditional rehabilitation. The subjects will be allocated randomly in three groups which are traditional rehabilitation (Group A), robotic training (Group B), and rTMS (Group C) respectively, with 35 people per group. The group B will be intervened 5 times per week and the group C will receive 10 times rTMS intervention during 4 weeks. At post-intervention and eighth weeks after intervention, basic examination will be executed including basic information, history, Mini-mental State examination, Short -Form 36, Modified Ashworth Scale, Fugl-Meyer assessment, static and dynamic motion examination, ultrasound assessment and examination of cardiorespiratory. Two-way mixed ANOVA will be used to analyze the differences of three groups and times.

Eligibility criteria: Inclusion Criteria:

* first-time onset of stroke
* reaching 20 years old and having clinical CT and MRI diagnosis of stroke
* hemiparesis with sitting ability after onset 3 months

Exclusion Criteria:

* Brunnstrom stage over grade V
* Combined other neurological diseases (epilepsy, polyneuropathy, Meniere's disease, vestibular neuritis, Parkinson's disease, dementia, spinocerebellar ataxia)
* lower extremity disease, included joint contracture, high muscle tone(MAS more than 3), L/E fracture, Joint replacement, long-term osteoarthritis pain
* unstable vital sign
* can't coordinate or Sign consent plan form

Primary outcomes:
measure: Change of walking speed
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of postural sway displacement
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of postural sway velocity
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of postural sway area
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of step time
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of stance time
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of swing time
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of single support time
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of double support time
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of step length
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of stance length
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of amplitude of Muscle activity
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of Functional Independence Measure (FIM)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of international Quality of Life Assessment Short Form -36 (SF-36)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary outcomes:
measure: Change of concentration of Serum albumin
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of concentration of Hemoglobin (Hb)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of concentration of Glucose
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of concentration of Cholesterol
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of concentration of Triglyceride
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of Berg balance test (BBS)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of Fugl-Meyer Assessment (FMA)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of Body Mass Index (BMI)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of Mini-mental state examination (MMSE)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of Modified Ashworth scale (MAS)
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
measure: Change of Muscle tone
timeFrame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Ta-Sen Wei, Doctor
role: PRINCIPAL_INVESTIGATOR
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