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Robotic Gait Training VS.Conventional Rehabilitation in SCI

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ClinicalTrials.gov Identifier: NCT01432990
Recruitment Status : Unknown
Verified July 2012 by Ratanapat Chanubol, Prasat Neurological Institute.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2011
Last Update Posted : July 17, 2012
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Ratanapat Chanubol, Prasat Neurological Institute

Brief Summary:
Until now, there's still no any strong evidence supported "which is the best way to restoration walking ability" in spinal cord injury. Most of the evidence suggest that, there is somehow better after gait rehabilitation for ASIA classification C and D but not improved walking ability for ASIA classification A and B. There is an RCT showed the evidence of repetitive locomotor training and physiotherapy could be improved walking and basic activities of daily living after stroke, these might be also really effect in SCI patients.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Robot gait training Other: control Phase 3

Detailed Description:
This study aim to study the effectiveness of conventional rehabilitation compare with robotic gait training machine in subacute SCI patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Gait Training VS. Conventional Physical Therapy in Spinal Cord Injury Patients.
Study Start Date : January 2013
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: robotic gait training
conventional physical therapy plus robot gait training program for SCI patients.
Device: Robot gait training
Robotic gait training for 20 minute include preparing and rest time for 10 minute plus conventional physical therapy program for 30 minute, totally 60 minute per day for 5 working day per week.
Other Name: Gait trainer GT1
No Intervention: control
Conventional physical therapy program for 60 minute per day for 5 working day per week.
Other: control
Conventional physical therapy program for 60 minute per day for 5 working day per week.



Primary Outcome Measures :
  1. Wernig scale [ Time Frame: 4 weeks. ]
    Walking ability classification in spinal cord injury patients.

  2. Barthel index [ Time Frame: 4 weeks. ]
    Measure activity of daily living


Secondary Outcome Measures :
  1. Repas [ Time Frame: 4 weeks. ]
    Spasticity measurement

  2. Manual muscle testing [ Time Frame: 4 weeks ]
    Measure muscle power in each key muscle according to ASIA classification.

  3. 10 meter walking test [ Time Frame: 4 weeks. ]
    If patients can walk, measure speed of walking with step length.

  4. 6 minute walking test [ Time Frame: 4 weeks ]
    If patient can walk, measure endurance.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subacute spinal cord injury ( C5-T12 level) patients.
  • ASIA classification C and D.
  • No previous joint contracture.
  • No severely active medical condition.
  • Can easily communicate with no obvious cognitive impairment.
  • Given signed inform consent.

Exclusion Criteria:

  • Previous injury or other neurological condition that related to neurodeficit in key muscles.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432990


Locations
Thailand
Ratanapat Chanubol Not yet recruiting
Bangkok, Thailand, 10400
Contact: Ratanapat Chanubol, MD.    662-3547078 ext 3170    cpaphan@yahoo.com   
Sponsors and Collaborators
Prasat Neurological Institute
Mahidol University
Investigators
Principal Investigator: Ratanapat Chanubol, MD. PM&R department, Prasat Neurological Institute, Bangkok, Thailand. 10400

Publications of Results:
Other Publications:
Responsible Party: Ratanapat Chanubol, Dr., Prasat Neurological Institute
ClinicalTrials.gov Identifier: NCT01432990     History of Changes
Other Study ID Numbers: SCIstemcell
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Ratanapat Chanubol, Prasat Neurological Institute:
SCI
gait
rehabilitation
robotic

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries