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Robotic Versus Conventional Training on Hemiplegic Gait.

NCT ID: NCT01187277

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Keywords

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stroke rehabilitation gait training robot-assisted therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

conventional therapy

Intervention Type 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 B

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

Group Type ACTIVE_COMPARATOR

conventional plus robotic gait assisted therapy

Intervention Type DEVICE

individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy

Interventions

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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

Intervention Type BEHAVIORAL

conventional plus robotic gait assisted therapy

individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy

Intervention Type DEVICE

Other Intervention Names

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Gait trainer GT1

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Prasat Neurological Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ratanapat Chanubol

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ratanapat Chanubol, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation department, Prasat Neurological Institute

Locations

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Prasat Neurological Institute

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 19627940 (View on PubMed)

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.

Reference Type RESULT
PMID: 18467648 (View on PubMed)

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.

Reference Type RESULT
PMID: 19109447 (View on PubMed)

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.

Reference Type RESULT
PMID: 17213237 (View on PubMed)

Other Identifiers

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BB200810

Identifier Type: -

Identifier Source: org_study_id