rTMS and Robotic Gait Training in Patients With Stroke

Last updated: June 30, 2021
Sponsor: Changhua Christian Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT03817385
CCH-160102
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 105
Study Start date:
February 01, 2019
Estimated Completion Date:
January 31, 2022

Study 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.

Connect with a study center

  • Changhua Christian Hospital

    Changhua, 500
    Taiwan

    Active - Recruiting

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