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Robotic Versus Conventional Training on Hemiplegic Gait. (BB200810)

This study has been completed.
Sponsor:
Collaborators:
Mahidol University
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Ratanapat Chanubol, Prasat Neurological Institute
ClinicalTrials.gov Identifier:
NCT01187277
First received: August 20, 2010
Last updated: July 15, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Stroke
 Behavioral: conventional therapy
Device: conventional plus robotic gait assisted therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Prasat Neurological Institute:

Primary Outcome Measures:
  • Functional Ambulation Categories (FAC, 0-5) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Description of ambulation level of the individual patient, whether and if, how much support is needed.

  • Barthel index (BI, 0-100) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assesses independence in activity of daily living


Secondary Outcome Measures:
  • Berg Balance Scale (BBS, 0-56 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assesses balance abilities.

  • REPAS -Muscle tone (REPAS, 0-52) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Sum score to assess muscle tone for the major joints of the upper and lower extremities.


Enrollment: 60
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 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
Active Comparator: 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
 Device: conventional plus robotic gait assisted therapy
individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy
Other Name: Gait trainer GT1

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187277

Locations
Thailand
Prasat Neurological Institute
Bangkok, Thailand, 10400
Sponsors and Collaborators
Prasat Neurological Institute
Mahidol University
Charite University, Berlin, Germany
Investigators
Principal Investigator: Ratanapat Chanubol, M.D. Rehabilitation department, Prasat Neurological Institute
  More Information

Publications:

Responsible Party: Ratanapat Chanubol, Dr., Prasat Neurological Institute
ClinicalTrials.gov Identifier: NCT01187277     History of Changes
Other Study ID Numbers: BB200810
Study First Received: August 20, 2010
Last Updated: July 15, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Prasat Neurological Institute:
stroke
rehabilitation
gait training
robot-assisted therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013