Robotic Versus Conventional Training on Hemiplegic Gait.

NCT01187277 | Completed Phase 3 DMC

• 1 other identifier: BB200810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; rehabilitation; gait training; robot-assisted therapy

Outcome Measures

Primary Outcomes (2)

• Functional Ambulation Categories (FAC, 0-5)

  Description of ambulation level of the individual patient, whether and if, how much support is needed.

  4 weeks

• Barthel index (BI, 0-100)

  Assesses independence in activity of daily living

  4 weeks

Secondary Outcomes (2)

• Berg Balance Scale (BBS, 0-56

  4 weeks

• REPAS -Muscle tone (REPAS, 0-52)

  4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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

Behavioral: conventional therapy

Group B

ACTIVE COMPARATOR

Group B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

Device: conventional plus robotic gait assisted therapy

Interventions

conventional therapy BEHAVIORAL

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

Group A

conventional plus robotic gait assisted therapy DEVICE

individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy

Also known as: Gait trainer GT1

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prasat Neurological Institute: lead
• Mahidol University: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Prasat Neurological Institute

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (4)

• 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.

  PMID: 19627940 RESULT

• 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.

  PMID: 18467648 RESULT

• 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.

  PMID: 19109447 RESULT

• 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.

  PMID: 17213237 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ratanapat Chanubol, M.D.

  Rehabilitation department, Prasat Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 24, 2010
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

TH (1)