Robotic Gait Training VS.Conventional Rehabilitation in SCI

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Prasat Neurological Institute
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Ratanapat Chanubol, Prasat Neurological Institute
ClinicalTrials.gov Identifier:
NCT01432990
First received: September 10, 2011
Last updated: July 15, 2012
Last verified: July 2012
  Purpose

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
Endpoint Classification: Efficacy Study
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 Prasat Neurological Institute:

Primary Outcome Measures:
  • Wernig scale [ Time Frame: 4 weeks. ] [ Designated as safety issue: No ]
    Walking ability classification in spinal cord injury patients.

  • Barthel index [ Time Frame: 4 weeks. ] [ Designated as safety issue: No ]
    Measure activity of daily living


Secondary Outcome Measures:
  • Repas [ Time Frame: 4 weeks. ] [ Designated as safety issue: No ]
    Spasticity measurement

  • Manual muscle testing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measure muscle power in each key muscle according to ASIA classification.

  • 10 meter walking test [ Time Frame: 4 weeks. ] [ Designated as safety issue: No ]
    If patients can walk, measure speed of walking with step length.

  • 6 minute walking test [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Ratanapat Chanubol, Dr., Prasat Neurological Institute
ClinicalTrials.gov Identifier: NCT01432990     History of Changes
Other Study ID Numbers: SCIstemcell
Study First Received: September 10, 2011
Last Updated: July 15, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Prasat Neurological Institute:
SCI
gait
rehabilitation
robotic

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

ClinicalTrials.gov processed this record on October 20, 2014