Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: tDCS; Device: Robotic-assisted gait training

• Registration Number: NCT01945515
• Lead Sponsor: Seoul National University Hospital

Brief Summary

1. Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients

2. Subjects chronic stroke patients with gait impairment

3. Methods

* Group 1: Robotic-assisted gait training with anodal tDCS (45 min)

* Group 2: Robotic-assisted gait training with sham tDCS (45 min)

* Duration of treatment: 2 weeks, 5 times a week

* Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-15
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-18
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Last Update Submitted: 2016-12-18
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
• Hemiplegic patients due to unilateral lesion
• Patients in chronic stage after 6 months from stroke onset
• Patients with gait impairment (FAC <= 4)
• Adult (Age >= 18)

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Exclusion Criteria

• Unstable vital sign
• History of seizure or cranial operation
• unable to walk before stroke
• bilateral hemispheric lesions
• metalic implant (cardiac pacemaker, artificial cochlear, etc.)
• severe cognitive deficit, MMSE < 10
• severe aphasic patient who cannot communicate at all

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot + anodal tDCS	Robotic-assisted gait training	Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
Robot + sham tDCS	Robotic-assisted gait training	Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
Robot + anodal tDCS	tDCS	Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
Robot + sham tDCS	tDCS	Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min

Primary Outcome Measures

Name	Time	Method
Functional Ambulatory Category (FAC)	4 weeks after treatment	Assesses functional ambulation in patients undergoing physical therapy

Secondary Outcome Measures

Name	Time	Method
6-min walk test	4 weeks after treatment	Walking distance for 6 min
Fugl-Meyer assessment scale for lower extremity	4 weeks after treatment	Assess the function of lower extremity in stroke patients
Motor evoked potential	1 day after treatment	Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
10-meter walk test	4 weeks after treatment	Time for walking 10 meters
Modified Rankin's Scale	4 weeks after treatment

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of