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

Stroke Clinical Trial

Official title:

Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945515
• Other study ID #: Robot-tDCS-2013
• Status: Completed
• Phase: N/A
• First received: September 15, 2013
• Last updated: December 18, 2016
• Start date: September 2013

Study information

• Verified date: December 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS
tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.
• Robotic-assisted gait training
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Ambulatory Category (FAC)	Assesses functional ambulation in patients undergoing physical therapy	Baseline	No
Primary	Functional Ambulatory Category (FAC)	Assesses functional ambulation in patients undergoing physical therapy	1 day after treatment	No
Primary	Functional Ambulatory Category (FAC)	Assesses functional ambulation in patients undergoing physical therapy	4 weeks after treatment	No
Secondary	10-meter walk test	Time for walking 10 meters	Baseline	No
Secondary	10-meter walk test	Time for walking 10 meters	1 day after treatment	No
Secondary	10-meter walk test	Time for walking 10 meters	4 weeks after treatment	No
Secondary	6-min walk test	Walking distance for 6 min	Baseline	No
Secondary	6-min walk test	Walking distance for 6 min	1 day after treatment	No
Secondary	6-min walk test	Walking distance for 6 min	4 weeks after treatment	No
Secondary	Modified Rankin's Scale		Baseline	No
Secondary	Modified Rankin's Scale		1 day after treatment	No
Secondary	Modified Rankin's Scale		4 weeks after treatment	No
Secondary	Fugl-Meyer assessment scale for lower extremity	Assess the function of lower extremity in stroke patients	Baseline	No
Secondary	Fugl-Meyer assessment scale for lower extremity	Assess the function of lower extremity in stroke patients	1 day after treatment	No
Secondary	Fugl-Meyer assessment scale for lower extremity	Assess the function of lower extremity in stroke patients	4 weeks after treatment	No
Secondary	Motor evoked potential	Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation	Baseline	No
Secondary	Motor evoked potential	Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation	1 day after treatment	No