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OpenTrials
Completed

NCT Number: NCT01187277

Robotic Versus Conventional Training on Hemiplegic Gait.

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prasat Neurological Institute

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

conventional plus robotic gait assisted therapy

Device

individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy

Other names: Gait trainer GT1

Primary outcomes

  1. Functional Ambulation Categories (FAC, 0-5)

    Time frame: 4 weeks

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

  2. Barthel index (BI, 0-100)

    Time frame: 4 weeks

    Assesses independence in activity of daily living

Secondary outcomes

  1. Berg Balance Scale (BBS, 0-56

    Time frame: 4 weeks

    Assesses balance abilities.

  2. REPAS -Muscle tone (REPAS, 0-52)

    Time frame: 4 weeks

    Sum score to assess muscle tone for the major joints of the upper and lower extremities.

Sponsors and collaborators

Lead sponsor

Prasat Neurological Institute

Other Gov

Collaborators

  • Charite University, Berlin, Germany
  • Mahidol University

Registry information

Official study title

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

Acronym: BB200810

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 24, 2010
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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