NCT01187277.
| Trial name or title | A randomised controlled trial on hemiplegic gait rehabilitation: robotic locomotor training versus conventional training in subacute stroke |
| Methods | RCT with 2 arms |
| Participants | Country: Thailand
Inclusion criteria: subacute first‐time stroke patients (haemorrhage and ischaemic), age 18 to 80 years, impaired FAC at initial score 0 to 2, cardiovascular stable, provided signed informed consent Exclusion criteria: unstable general medical condition, severe malposition or fixed contracture of joint with an extension deficit > 30°, any functional impairment before stroke, cannot adequately co‐operate in training, severe communication problems, severe cognitive‐perceptual deficits |
| Interventions | Group A: conventional therapy: 50 minutes individual physiotherapy and 60 minutes individual occupational therapy per workday (5 times per week) for 4 consecutive weeks Group B: conventional therapy plus robot‐assisted gait training: 30 minutes individual physiotherapy plus 20 minutes robotic‐assisted gait training (with Gait Trainer GT1) and 60 minutes individual occupational therapy per workday (5 times per week) for 4 consecutive weeks |
| Outcomes | Primary outcomes: FAC 0 to 5 and Barthel Index 0 to 100 Secondary outcome: Berg Balance Scale 0 to 56, Resistance to Passive Movement Scale (REPAS)‐Muscle tone 0 to 52 |
| Starting date | January 2011 |
| Contact information | Principal Investigator: Ratanapat Chanubol, MD, Rehabilitation Department, Prasat Neurological Institute, Mahidol University |
| Notes | Study Completion Date: July 2012 Enrolment: 60 |