rTMS and Robotic Gait Training in Patients With Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
repetitive TMS
robotic GT
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Transcranial magnetic stimulation, Robotic gait training, Gait, Spasticity
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
Sites / Locations
- Changhua Christian HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
repetitive TMS (Transcranial Magnetic Stimulation)
robotic GT (Gait Training)
traditional rehabilitation
Arm Description
rTMS and physical / occupational therapy
robotic gait training for 20 times and physical / occupational therapy
patient only received traditional rehabilitation program
Outcomes
Primary Outcome Measures
Change of walking speed
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 double support time
Use computerized dynography to measure spatial gait parameter: double 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.
Secondary Outcome Measures
Change of concentration of Serum albumin
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)
The concentration of Hb in the blood test.
Change of concentration of Glucose
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
The concentration of Cholesterol in the blood test.
Change of concentration of Triglyceride
The concentration of Triglyceride in the blood test.
Change of Berg balance test (BBS)
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)
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 Body Mass Index (BMI)
(body weight) kg/(height) m*(height)m
Change of Mini-mental state examination (MMSE)
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.
Change of Modified Ashworth scale (MAS)
measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone
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)
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
Change of Muscle tone
measure the muscle tone (kg/m) under muscle resting. Target muscles are quadriceps, hamstrings, anterior tibialis, gastrocnemius.
Full Information
NCT ID
NCT03817385
First Posted
December 28, 2018
Last Updated
June 30, 2021
Sponsor
Changhua Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03817385
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Transcranial magnetic stimulation, Robotic gait training, Gait, Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
repetitive TMS (Transcranial Magnetic Stimulation)
Arm Type
Experimental
Arm Description
rTMS and physical / occupational therapy
Arm Title
robotic GT (Gait Training)
Arm Type
Experimental
Arm Description
robotic gait training for 20 times and physical / occupational therapy
Arm Title
traditional rehabilitation
Arm Type
No Intervention
Arm Description
patient only received traditional rehabilitation program
Intervention Type
Device
Intervention Name(s)
repetitive TMS
Intervention Description
rTMS x 10 times
Intervention Type
Device
Intervention Name(s)
robotic GT
Intervention Description
robotic gait training for 20 times
Primary Outcome Measure Information:
Title
Change of walking speed
Description
walk 6m to measure the time spent, patients can walk with foot orthosis and assistive devices
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
Title
Change of postural sway displacement
Description
Use computerized dynography to measure the postural sway displacement (mm)
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
Title
Change of postural sway velocity
Description
Use computerized dynography to measure the postural sway velocity (mm/s)
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
Title
Change of postural sway area
Description
computerized dynography to measure the postural sway area (mm^2)
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
Title
Change of step time
Description
Use computerized dynography to measure spatial gait parameter: step time (ms)
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
Title
Change of stance time
Description
Use computerized dynography to measure spatial gait parameter: stance time (ms)
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
Title
Change of swing time
Description
Use computerized dynography to measure spatial gait parameter: swing time (ms)
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
Title
Change of single support time
Description
Use computerized dynography to measure spatial gait parameter: single support time (ms)
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
Title
Change of double support time
Description
Use computerized dynography to measure spatial gait parameter: double support time (ms)
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
Title
Change of step length
Description
Use computerized dynography to measure spatial gait parameter: step distance (mm)
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
Title
Change of stance length
Description
Use computerized dynography to measure spatial gait parameter: stance distance (mm)
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
Title
Change of amplitude of Muscle activity
Description
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.
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
Title
Change of Functional Independence Measure (FIM)
Description
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.
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
Title
Change of international Quality of Life Assessment Short Form -36 (SF-36)
Description
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.
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
Secondary Outcome Measure Information:
Title
Change of concentration of Serum albumin
Description
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.
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
Title
Change of concentration of Hemoglobin (Hb)
Description
The concentration of Hb in the blood test.
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
Title
Change of concentration of Glucose
Description
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
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
Title
Change of concentration of Cholesterol
Description
The concentration of Cholesterol in the blood test.
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
Title
Change of concentration of Triglyceride
Description
The concentration of Triglyceride in the blood test.
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
Title
Change of Berg balance test (BBS)
Description
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
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
Title
Change of Fugl-Meyer Assessment (FMA)
Description
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)
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
Title
Change of Body Mass Index (BMI)
Description
(body weight) kg/(height) m*(height)m
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
Title
Change of Mini-mental state examination (MMSE)
Description
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.
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
Title
Change of Modified Ashworth scale (MAS)
Description
measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone
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)
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
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
Title
Change of Muscle tone
Description
measure the muscle tone (kg/m) under muscle resting. Target muscles are quadriceps, hamstrings, anterior tibialis, gastrocnemius.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PangTa Liu
Phone
886-4-7238595
Ext
7427
Email
105546@cch.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ta-Sen Wei, Doctor
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tasen Wei
Phone
886-4-7238595
Ext
7416
Email
tasen@cch.org.tw
First Name & Middle Initial & Last Name & Degree
Tasen Wei
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
only for research
Citations:
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rTMS and Robotic Gait Training in Patients With Stroke
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