Robotic Versus Conventional Training on Hemiplegic Gait.

Stroke Clinical Trial

— BB200810  

Official title:

A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187277
• Other study ID #: BB200810
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2010
• Last updated: July 15, 2012
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Prasat Neurological Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• conventional therapy
conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

Device:
• conventional plus robotic gait assisted therapy
individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy

Locations

Country	Name	City	State
Thailand	Prasat Neurological Institute	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Prasat Neurological Institute	Charite University, Berlin, Germany, Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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: 10.1177/154596830832663 — View 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. do — View Citation

Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoölig 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Ambulation Categories (FAC, 0-5)	Description of ambulation level of the individual patient, whether and if, how much support is needed.	4 weeks	Yes
Primary	Barthel index (BI, 0-100)	Assesses independence in activity of daily living	4 weeks	Yes
Secondary	Berg Balance Scale (BBS, 0-56	Assesses balance abilities.	4 weeks	Yes
Secondary	REPAS -Muscle tone (REPAS, 0-52)	Sum score to assess muscle tone for the major joints of the upper and lower extremities.	4 weeks	Yes