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Robotic Gait Training VS.Conventional Rehabilitation in SCI

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Ratanapat Chanubol, Prasat Neurological Institute.
Recruitment status was:  Not yet recruiting
Mahidol University
Information provided by (Responsible Party):
Ratanapat Chanubol, Prasat Neurological Institute Identifier:
First received: September 10, 2011
Last updated: July 15, 2012
Last verified: July 2012
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 Intervention Phase
Spinal Cord Injury Device: Robot gait training Other: control Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Gait Training VS. Conventional Physical Therapy in Spinal Cord Injury Patients.

Resource links provided by NLM:

Further study details as provided by Ratanapat Chanubol, Prasat Neurological Institute:

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

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

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

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

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

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

Estimated Enrollment: 16
Study Start Date: January 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01432990

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

Responsible Party: Ratanapat Chanubol, Dr., Prasat Neurological Institute Identifier: NCT01432990     History of Changes
Other Study ID Numbers: SCIstemcell
Study First Received: September 10, 2011
Last Updated: July 15, 2012

Keywords provided by Ratanapat Chanubol, Prasat Neurological Institute:

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on August 16, 2017