Robotic Gait Training VS.Conventional Rehabilitation in SCI

This study is not yet open for participant recruitment.

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

History of Changes

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:

MedlinePlus related topics: Rehabilitation Spinal Cord Injuries

U.S. FDA Resources

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

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:

Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoölig 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.

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.

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.

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 May 31; [Epub ahead of print]

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
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013

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