Clinical Trials/NCT03817385

NCT03817385

Unknown

Not Applicable

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) and Robotic Gait Training on Lower-extremity Function and Gait in Patients With Stroke

Changhua Christian Hospital1 site in 1 country105 target enrollmentFebruary 1, 2019

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Changhua Christian Hospital
Enrollment: 105
Locations: 1
Primary Endpoint: Change of walking speed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2019

End Date

January 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Changhua Christian Hospital

Responsible Party

Principal Investigator

Ta-Sen Wei,MD

Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Changhua Christian Hospital

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

Outcomes

Primary Outcomes

Change of walking speed

Time Frame: 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

Use computerized dynography to measure the postural sway displacement (mm)

Change of postural sway velocity

Use computerized dynography to measure the postural sway velocity (mm/s)

Change of postural sway area

computerized dynography to measure the postural sway area (mm\^2)

Change of step time

Use computerized dynography to measure spatial gait parameter: step time (ms)

Change of stance time

Use computerized dynography to measure spatial gait parameter: stance time (ms)

Change of swing time

Use computerized dynography to measure spatial gait parameter: swing time (ms)

Change of single support time

Use computerized dynography to measure spatial gait parameter: single support time (ms)

Change of step length

Use computerized dynography to measure spatial gait parameter: step distance (mm)

Change of stance length

Use computerized dynography to measure spatial gait parameter: stance distance (mm)

Change of amplitude of Muscle activity

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)

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)

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

Use computerized dynography to measure spatial gait parameter: double support time (ms)

Secondary Outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)