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. 2017 May 10;2017(5):CD006185. doi: 10.1002/14651858.CD006185.pub4

NCT02694302.

Trial name or title Clinical trial of robot‐assisted‐gait‐training (RAGT) in stroke patients (Walkbot)
Methods Randomised
2 arms
Participants Inclusion criteria
  • Age older than 19 years and younger than 80 years

  • Weight under 100 kg

  • Height less than 200 cm

  • Able to walk independently before onset of stroke

  • Ischaemic or haemorrhagic stroke patients

  • Motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment

  • FAC under 3 (0 ˜ 2)

  • Subacute stroke patients, i.e. after 3 days and before 3 months of stroke onset

  • Be informed of the nature of the study and agreed on written consent voluntarily

  • Taking medications or scheduled medications due to stroke


Exclusion criteria
  • Contraindications to weight bearing such as fractures, etc.

  • Uncontrolled stage 2 hypertension (systolic over 160 mm Hg or diastolic over 100 mm Hg) or with uncontrolled orthostatic hypotension

  • Cardiopulmonary disease or other underlying diseases that cannot tolerate gait training

  • Severe skin damage and bedsore on wearing part of the trial device

  • Pregnant or breastfeeding

  • Participationin other clinical trials within 30 days

  • People whom the investigator considers inappropriate to participate in the study

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

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

Outcomes Primary outcome measure
  • FAC


Secondary outcome measures
  • Motricity Index

  • 10‐metre walk test

  • 6‐minute walk test

  • Medical Research Council

  • Modified Ashworth Scale

  • Fugl‐Meyer Assessment

  • Modified Barthel Index

  • National Institutes of Health Stroke Scale

  • Beck Depression Inventory

  • Treatment Satisfaction Survey

Starting date March 2014
Contact information P&S Mechanics Co., Ltd.
Notes