rTMS and Robotic Gait Training in Patients With Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Device: repetitive TMS; Device: robotic GT

• Registration Number: NCT03817385
• Lead Sponsor: Changhua Christian Hospital

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.

Study Timeline

• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-25
• Study Start: 2019-02-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-01
• Primary Completion: 2021-12
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repetitive TMS (Transcranial Magnetic Stimulation)	repetitive TMS	rTMS and physical / occupational therapy
robotic GT (Gait Training)	robotic GT	robotic gait training for 20 times and physical / occupational therapy

Primary Outcome Measures

Name	Time	Method
Change of walking speed	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	walk 6m to measure the time spent, patients can walk with foot orthosis and assistive devices
Change of postural sway displacement	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	Use computerized dynography to measure the postural sway displacement (mm)
Change of postural sway velocity	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	Use computerized dynography to measure the postural sway velocity (mm/s)
Change of postural sway area	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	computerized dynography to measure the postural sway area (mm\^2)
Change of step time	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	Use computerized dynography to measure spatial gait parameter: step time (ms)
Change of stance time	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	Use computerized dynography to measure spatial gait parameter: stance time (ms)
Change of swing time	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	Use computerized dynography to measure spatial gait parameter: swing time (ms)
Change of single support time	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	Use computerized dynography to measure spatial gait parameter: single support time (ms)
Change of step length	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	Use computerized dynography to measure spatial gait parameter: step distance (mm)
Change of stance length	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	Use computerized dynography to measure spatial gait parameter: stance distance (mm)
Change of amplitude of Muscle activity	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	use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self selected speed in 6 meters.
Change of Functional Independence Measure (FIM)	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	FIM™ is comprised of 18 items, grouped into 2 subscales - motor and cognition.; The motor subscale includes: Eating Grooming Bathing Dressing, upper body Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchair Transfers - toilet Transfers - bath/shower Walk/wheelchair Stairs; The cognition subscale includes: Comprehension Expression Social interaction Problem solving Memory Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.; The total score for the FIM motor subscale will be a value between 13 and 91. The total score for the FIM cognition subscale will be a value between 5 and 35.; The total score for the FIM instrument will be a value between 18 and 126.
Change of international Quality of Life Assessment Short Form -36 (SF-36)	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	including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.; Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.
Change of double support time	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	Use computerized dynography to measure spatial gait parameter: double support time (ms)

Secondary Outcome Measures

Name	Time	Method
Change of concentration of Serum albumin	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	The concentration of Serum albumin in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.; Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.
Change of concentration of Hemoglobin (Hb)	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	The concentration of Hb in the blood test.
Change of concentration of Glucose	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	The concentration of Glucose in the blood test. The Spot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation
Change of concentration of Cholesterol	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	The concentration of Cholesterol in the blood test.
Change of concentration of Triglyceride	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	The concentration of Triglyceride in the blood test.
Change of Berg balance test (BBS)	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	Including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.; The item scores are summed, minimum score =0, maximum score = 56
Change of Fugl-Meyer Assessment (FMA)	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	Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (Upper extremity maximum score = 66; Lower extremity maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44)
Change of Modified Ashworth scale (MAS)	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	measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone; 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM); 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3. Considerable increase in muscle tone, passive movement difficult; 4. Affected part(s) rigid in flexion or extension
Change of Muscle tone	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 the muscle tone (kg/m) under muscle resting. Target muscles are quadriceps, hamstrings, anterior tibialis, gastrocnemius.
Change of Body Mass Index (BMI)	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	(body weight) kg/(height) m\*(height)m
Change of Mini-mental state examination (MMSE)	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	It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan