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StrokeNCT03817385

rTMS and Robotic Gait Training in Patients With Stroke

A study testing repetitive TMS and robotic GT in people with Stroke, run by Changhua Christian Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke
What is being tested?
repetitive TMS and robotic GT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteTaiwan
Study dates
1 Feb 2019to Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

PangTa Liu contact

886-4-7238595 ext. 7427

105546@cch.org.tw

Taiwan1 site, 1 recruiting

  • Changhua Christian Hospital

    Changhua, 500

    Tasen Wei, 886-4-7238595 ext. 7416, tasen@cch.org.tw

    Tasen Wei

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
repetitive TMS, robotic GT
Keywords
Transcranial magnetic stimulation, Robotic gait training, Gait, Spasticity
Medical subject headings
Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • repetitive TMSDevice

    rTMS x 10 times

  • robotic GTDevice

    robotic gait training for 20 times

Study groups in NCT03817385
Study groupRoleWhat they receive
repetitive TMS (Transcranial Magnetic Stimulation)ExperimentalrTMS and physical / occupational therapy
Receives: Device: repetitive TMS
robotic GT (Gait Training)Experimentalrobotic gait training for 20 times and physical / occupational therapy
Receives: Device: robotic GT
traditional rehabilitationNo interventionpatient only received traditional rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of walking speed

    walk 6m to measure the time spent, patients can walk with foot orthosis and assistive devices

    Measured: 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

  2. Change of postural sway displacement

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

    Measured: 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

  3. Change of postural sway velocity

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

    Measured: 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

  4. Change of postural sway area

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

    Measured: 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

  5. Change of step time

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

    Measured: 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

  6. Change of stance time

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

    Measured: 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

  7. Change of swing time

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

    Measured: 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

  8. Change of single support time

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

    Measured: 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

  9. Change of double support time

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

    Measured: 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. Change of step length

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

    Measured: 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

  11. Change of stance length

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

    Measured: 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

  12. 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.

    Measured: 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

  13. 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.

    Measured: 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

  14. 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.

    Measured: 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 (11)

  1. 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.

    Measured: 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

  2. Change of concentration of Hemoglobin (Hb)

    The concentration of Hb in the blood test.

    Measured: 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

  3. 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

    Measured: 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

  4. Change of concentration of Cholesterol

    The concentration of Cholesterol in the blood test.

    Measured: 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

  5. Change of concentration of Triglyceride

    The concentration of Triglyceride in the blood test.

    Measured: 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

  6. 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

    Measured: 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

  7. 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)

    Measured: 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

  8. Change of Body Mass Index (BMI)

    (body weight) kg/(height) m*(height)m

    Measured: 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

  9. 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.

    Measured: 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. 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

    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

    Measured: 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

  11. Change of Muscle tone

    measure the muscle tone (kg/m) under muscle resting. Target muscles are quadriceps, hamstrings, anterior tibialis, gastrocnemius.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2019
  2. Study start1 Feb 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03817385
Sponsor's protocol ID
CCH-160102
Status last verified
Jun 2021
First submitted
28 Dec 2018
Last updated
1 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: only for research

Publications

  • Brunt D, Greenberg B, Wankadia S, Trimble MA, Shechtman O. The effect of foot placement on sit to stand in healthy young subjects and patients with hemiplegia. Arch Phys Med Rehabil. 2002 Jul;83(7):924-9. doi: 10.1053/apmr.2002.3324.

    PubMed 12098151

  • Dettmann MA, Linder MT, Sepic SB. Relationships among walking performance, postural stability, and functional assessments of the hemiplegic patient. Am J Phys Med. 1987 Apr;66(2):77-90.

    PubMed 3578493

  • Hidler J, Nichols D, Pelliccio M, Brady K. Advances in the understanding and treatment of stroke impairment using robotic devices. Top Stroke Rehabil. 2005 Spring;12(2):22-35. doi: 10.1310/RYT5-62N4-CTVX-8JTE.

    PubMed 15940582

  • Kakuda W, Abo M, Watanabe S, Momosaki R, Hashimoto G, Nakayama Y, Kiyama A, Yoshida H. High-frequency rTMS applied over bilateral leg motor areas combined with mobility training for gait disturbance after stroke: a preliminary study. Brain Inj. 2013;27(9):1080-6. doi: 10.3109/02699052.2013.794973.

    PubMed 23834634

  • Kim J, Park JH, Yim J. Effects of respiratory muscle and endurance training using an individualized training device on the pulmonary function and exercise capacity in stroke patients. Med Sci Monit. 2014 Dec 5;20:2543-9. doi: 10.12659/MSM.891112.

    PubMed 25488849

  • Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8.

    PubMed 18467648

  • Israel JF, Campbell DD, Kahn JH, Hornby TG. Metabolic costs and muscle activity patterns during robotic- and therapist-assisted treadmill walking in individuals with incomplete spinal cord injury. Phys Ther. 2006 Nov;86(11):1466-78. doi: 10.2522/ptj.20050266.

    PubMed 17079746

  • Kim P, Warren S, Madill H, Hadley M. Quality of life of stroke survivors. Qual Life Res. 1999 Jun;8(4):293-301. doi: 10.1023/a:1008927431300.

    PubMed 10472161

  • Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.

    PubMed 16151035

  • Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. doi: 10.1016/j.apmr.2005.01.011.

    PubMed 16084820

  • Nichols DS. Balance retraining after stroke using force platform biofeedback. Phys Ther. 1997 May;77(5):553-8. doi: 10.1093/ptj/77.5.553.

    PubMed 9149764

  • Wang RY, Tseng HY, Liao KK, Wang CJ, Lai KL, Yang YR. rTMS combined with task-oriented training to improve symmetry of interhemispheric corticomotor excitability and gait performance after stroke: a randomized trial. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):222-30. doi: 10.1177/1545968311423265. Epub 2011 Oct 5.

    PubMed 21974983

Questions about this trial

What is this clinical trial studying?

A study testing repetitive TMS and robotic GT in people with Stroke, run by Changhua Christian Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact PangTa Liu (886-4-7238595 ext. 7427, 105546@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03817385, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

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