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Completed

NCT Number: NCT02694302

Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients

A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Rehabilitation Center, Seoul, South Korea

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About this study

Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Experimental group receives robot-assisted-gait-training and conventional gait training.

Active comparator group receives conventional gait training only as the same number as the experimental group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age more than 19 and under 80
  • Weight under 100kg
  • Height less than 200cm
  • Able to walk independently before onset of stroke
  • Ischemic or hemorrhagic stroke patients
  • Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
  • FAC(Functional Ambulation Category) under 3 (0~2)
  • Subacute stroke patients after 3 days and before 3 months of onset
  • Be informed of the nature of the study and agreed on written consent voluntarily
  • Patients taking medications or scheduled medications due to stroke

Exclusion criteria

  • Patients with contraindications to weight bearing such as fractures, etc.
  • Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
  • Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
  • Patients with severe skin damage and bedsore on wearing part of the trial device
  • Pregnant or breast-feeding
  • Participation within 30 days of the other clinical trials
  • Patients whom the investigator considers inappropriate to participate in the study

Treatment and study plan

Walkbot

Device

Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.

Conventional physical therapy

Device

Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.

Primary outcomes

  1. Functional Ambulation Category(FAC)

    Time frame: 9 weeks from baseline

Secondary outcomes

  1. Motricity Index(MI)

    Time frame: 9 weeks from baseline

  2. 10 Meter Walk Test(10MWT)

    Time frame: 9 weeks from baseline

  3. 6 Minute Walk Test(6MWT)

    Time frame: 9 weeks from baseline

  4. Medical Research Council(MRC) Scale

    Time frame: 9 weeks from baseline

  5. Modified Ashworth Scale (MAS)

    Time frame: 9 weeks from baseline

  6. Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke

    Time frame: 9 weeks from baseline

  7. Modified Barthel Index(MBI)

    Time frame: 9 weeks from baseline

  8. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 9 weeks from baseline

  9. Beck's Depression Inventory test (BDI)

    Time frame: 9 weeks from baseline

  10. Treatment Satisfaction Survey

    Time frame: 9 weeks from baseline

Sponsors and collaborators

Lead sponsor

P&S Mechanics Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training

Acronym: Walkbot

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 29, 2016
Registry last updated
Sep 27, 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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