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

August 20, 2010
July 15, 2012
January 2011
May 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01187277 on ClinicalTrials.gov Archive Site
  • 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.
  • Barthel Index (BI, 0-100) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assesses the abilities of daily living.
  • 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.
Not Provided
Not Provided
 
Robotic Versus Conventional Training on Hemiplegic Gait.
A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • 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
    Other Name: Gait trainer GT1
  • 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
    Intervention: Behavioral: conventional therapy
  • 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
    Intervention: Device: conventional plus robotic gait assisted therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01187277
BB200810
Yes
Ratanapat Chanubol, Prasat Neurological Institute
Prasat Neurological Institute
  • Mahidol University
  • Charite University, Berlin, Germany
Principal Investigator: Ratanapat Chanubol, M.D. Rehabilitation department, Prasat Neurological Institute
Prasat Neurological Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP