rTMS and Robotic Gait Training in Patients With Stroke

NCT ID: NCT03817385

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

repetitive TMS (Transcranial Magnetic Stimulation)

rTMS and physical / occupational therapy

Group Type EXPERIMENTAL

repetitive TMS

Intervention Type DEVICE

rTMS x 10 times

robotic GT (Gait Training)

robotic gait training for 20 times and physical / occupational therapy

Group Type EXPERIMENTAL

robotic GT

Intervention Type DEVICE

robotic gait training for 20 times

traditional rehabilitation

patient only received traditional rehabilitation program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

repetitive TMS

rTMS x 10 times

Intervention Type DEVICE

robotic GT

robotic gait training for 20 times

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ta-Sen Wei,MD

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ta-Sen Wei, Doctor

Role: PRINCIPAL_INVESTIGATOR

Changhua Christian Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changhua Christian Hospital

Changhua, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

PangTa Liu

Role: CONTACT

886-4-7238595 ext. 7427

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tasen Wei

Role: primary

886-4-7238595 ext. 7416

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12098151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3578493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15940582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23834634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25488849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18467648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17079746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10472161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16151035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16084820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9149764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21974983 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCH-160102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.