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Completed

NCT Number: NCT01945515

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

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.

Other names: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)

Robotic-assisted gait training

Device

Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments

Other names: Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)

Primary outcomes

  1. Functional Ambulatory Category (FAC)

    Time frame: Baseline

    Assesses functional ambulation in patients undergoing physical therapy

  2. Functional Ambulatory Category (FAC)

    Time frame: 1 day after treatment

    Assesses functional ambulation in patients undergoing physical therapy

  3. Functional Ambulatory Category (FAC)

    Time frame: 4 weeks after treatment

    Assesses functional ambulation in patients undergoing physical therapy

Secondary outcomes

  1. 10-meter walk test

    Time frame: Baseline

    Time for walking 10 meters

  2. 10-meter walk test

    Time frame: 1 day after treatment

    Time for walking 10 meters

  3. 10-meter walk test

    Time frame: 4 weeks after treatment

    Time for walking 10 meters

  4. 6-min walk test

    Time frame: Baseline

    Walking distance for 6 min

  5. 6-min walk test

    Time frame: 1 day after treatment

    Walking distance for 6 min

  6. 6-min walk test

    Time frame: 4 weeks after treatment

    Walking distance for 6 min

  7. Modified Rankin's Scale

    Time frame: Baseline

  8. Modified Rankin's Scale

    Time frame: 1 day after treatment

  9. Modified Rankin's Scale

    Time frame: 4 weeks after treatment

  10. Fugl-Meyer assessment scale for lower extremity

    Time frame: Baseline

    Assess the function of lower extremity in stroke patients

  11. Fugl-Meyer assessment scale for lower extremity

    Time frame: 1 day after treatment

    Assess the function of lower extremity in stroke patients

  12. Fugl-Meyer assessment scale for lower extremity

    Time frame: 4 weeks after treatment

    Assess the function of lower extremity in stroke patients

  13. Motor evoked potential

    Time frame: Baseline

    Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation

  14. Motor evoked potential

    Time frame: 1 day after treatment

    Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
First posted
Sep 18, 2013
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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