search
Back to results

Robotic Gait Training VS.Conventional Rehabilitation in SCI

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Robot gait training
control
Sponsored by
Prasat Neurological Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring SCI, gait, rehabilitation, robotic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ratanapat Chanubol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

robotic gait training

control

Arm Description

conventional physical therapy plus robot gait training program for SCI patients.

Conventional physical therapy program for 60 minute per day for 5 working day per week.

Outcomes

Primary Outcome Measures

Wernig scale
Walking ability classification in spinal cord injury patients.
Barthel index
Measure activity of daily living

Secondary Outcome Measures

Repas
Spasticity measurement
Manual muscle testing
Measure muscle power in each key muscle according to ASIA classification.
10 meter walking test
If patients can walk, measure speed of walking with step length.
6 minute walking test
If patient can walk, measure endurance.

Full Information

First Posted
September 10, 2011
Last Updated
July 15, 2012
Sponsor
Prasat Neurological Institute
Collaborators
Mahidol University
search

1. Study Identification

Unique Protocol Identification Number
NCT01432990
Brief Title
Robotic Gait Training VS.Conventional Rehabilitation in SCI
Official Title
Robotic Gait Training VS. Conventional Physical Therapy in Spinal Cord Injury Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prasat Neurological Institute
Collaborators
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
SCI, gait, rehabilitation, robotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
robotic gait training
Arm Type
Experimental
Arm Description
conventional physical therapy plus robot gait training program for SCI patients.
Arm Title
control
Arm Type
No Intervention
Arm Description
Conventional physical therapy program for 60 minute per day for 5 working day per week.
Intervention Type
Device
Intervention Name(s)
Robot gait training
Other Intervention Name(s)
Gait trainer GT1
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
Conventional physical therapy program for 60 minute per day for 5 working day per week.
Primary Outcome Measure Information:
Title
Wernig scale
Description
Walking ability classification in spinal cord injury patients.
Time Frame
4 weeks.
Title
Barthel index
Description
Measure activity of daily living
Time Frame
4 weeks.
Secondary Outcome Measure Information:
Title
Repas
Description
Spasticity measurement
Time Frame
4 weeks.
Title
Manual muscle testing
Description
Measure muscle power in each key muscle according to ASIA classification.
Time Frame
4 weeks
Title
10 meter walking test
Description
If patients can walk, measure speed of walking with step length.
Time Frame
4 weeks.
Title
6 minute walking test
Description
If patient can walk, measure endurance.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratanapat Chanubol, MD.
Organizational Affiliation
PM&R department, Prasat Neurological Institute, Bangkok, Thailand. 10400
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ratanapat Chanubol
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratanapat Chanubol, MD.
Phone
662-3547078
Ext
3170
Email
cpaphan@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21625239
Citation
Schwartz I, Sajina A, Neeb M, Fisher I, Katz-Luerer M, Meiner Z. Locomotor training using a robotic device in patients with subacute spinal cord injury. Spinal Cord. 2011 Oct;49(10):1062-7. doi: 10.1038/sc.2011.59. Epub 2011 May 31.
Results Reference
background
PubMed Identifier
17213237
Citation
Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
Results Reference
result
PubMed Identifier
21674390
Citation
Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. doi: 10.1682/jrrd.2010.04.0055.
Results Reference
result
PubMed Identifier
21675354
Citation
Taylor-Schroeder S, LaBarbera J, McDowell S, Zanca JM, Natale A, Mumma S, Gassaway J, Backus D. The SCIRehab project: treatment time spent in SCI rehabilitation. Physical therapy treatment time during inpatient spinal cord injury rehabilitation. J Spinal Cord Med. 2011;34(2):149-61. doi: 10.1179/107902611X12971826988057.
Results Reference
result

Learn more about this trial

Robotic Gait Training VS.Conventional Rehabilitation in SCI

We'll reach out to this number within 24 hrs