rTMS and Robotic Gait Training in Patients With Stroke

Changhua Christian Medical Foundation

Status: Unknown

Conditions: Stroke

Treatments: Device: robotic GT; Device: repetitive TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03817385

CCH-160102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

repetitive TMS (Transcranial Magnetic Stimulation)

Experimental group

Description:

rTMS and physical / occupational therapy

Treatment:

Device: repetitive TMS

robotic GT (Gait Training)

Experimental group

Description:

robotic gait training for 20 times and physical / occupational therapy

Treatment:

Device: robotic GT

traditional rehabilitation

No Intervention group

Description:

patient only received traditional rehabilitation program