Clinical trial NCT01187277: Robotic Versus Conventional Training on Hemiplegic Gait.
Official title: A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
rehabilitation
gait training
robot-assisted therapy
Lead sponsor: Prasat Neurological Institute
Sponsor class: OTHER_GOV
Collaborators: name: Mahidol University
name: Charite University, Berlin, Germany
First posted: 2010-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.


Eligibility criteria: Inclusion criteria:

* Subacute first-time stroke patients(hemorrhage and ischemic)
* Age 18-80 years.
* Impaired Functional Ambulation Category at initial score 0-2
* Cardiovascular stable
* Given signed inform consent

Exclusion Criteria:

* Unstable general medical condition
* Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree
* Any functional impairment prior to stroke
* Can not adequately cooperate in training

  * Severe communication problems
  * Severe cognitive - perceptual deficits

Primary outcomes:
measure: Functional Ambulation Categories (FAC, 0-5)
timeFrame: 4 weeks
measure: Barthel index (BI, 0-100)
timeFrame: 4 weeks
Secondary outcomes:
measure: Berg Balance Scale (BBS, 0-56
timeFrame: 4 weeks
measure: REPAS -Muscle tone (REPAS, 0-52)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Prasat Neurological Institute
Study officials:
affiliation: Rehabilitation department, Prasat Neurological Institute
name: Ratanapat Chanubol, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz I, Sajin A, Fisher I, Neeb M, Shochina M, Katz-Leurer M, Meiner Z. The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. PM R. 2009 Jun;1(6):516-23. doi: 10.1016/j.pmrj.2009.03.009.
citation: Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8.
citation: Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632.
citation: Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.