Robotic Gait Training VS.Conventional Rehabilitation in SCI

Sponsor

Prasat Neurological Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT01432990

Collaborator

Mahidol University (Other)

Enrollment

Location

Arms

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Wernig scale [4 weeks.]
Walking ability classification in spinal cord injury patients.
Barthel index [4 weeks.]
Measure activity of daily living

Secondary Outcome Measures

Repas [4 weeks.]
Spasticity measurement
Manual muscle testing [4 weeks]
Measure muscle power in each key muscle according to ASIA classification.
10 meter walking test [4 weeks.]
If patients can walk, measure speed of walking with step length.
6 minute walking test [4 weeks]
If patient can walk, measure endurance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ratanapat Chanubol	Bangkok		Thailand	10400

Sponsors and Collaborators

Prasat Neurological Institute
Mahidol University

Investigators

Principal Investigator: Ratanapat Chanubol, MD., PM&R department, Prasat Neurological Institute, Bangkok, Thailand. 10400

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Ratanapat Chanubol, Dr., Prasat Neurological Institute

ClinicalTrials.gov Identifier:

NCT01432990

Other Study ID Numbers:

SCIstemcell

First Posted:

Sep 13, 2011

Last Update Posted:

Jul 17, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Ratanapat Chanubol, Dr., Prasat Neurological Institute

Additional relevant MeSH terms:

Spinal Cord Injuries

Study Results

No Results Posted as of Jul 17, 2012