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Robotic Gait Training VS.Conventional Rehabilitation in SCI

NCT ID: NCT01432990

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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

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

Conditions

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Spinal Cord Injury

Keywords

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SCI gait rehabilitation robotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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robotic gait training

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

Group Type EXPERIMENTAL

Robot gait training

Intervention Type DEVICE

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.

control

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

Group Type NO_INTERVENTION

control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

control

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

Intervention Type OTHER

Other Intervention Names

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Gait trainer GT1

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Prasat Neurological Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ratanapat Chanubol

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ratanapat Chanubol, MD.

Role: PRINCIPAL_INVESTIGATOR

PM&R department, Prasat Neurological Institute, Bangkok, Thailand. 10400

Locations

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Ratanapat Chanubol

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Facility Contacts

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Ratanapat Chanubol, MD.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21625239 (View on PubMed)

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.

Reference Type RESULT
PMID: 17213237 (View on PubMed)

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.

Reference Type RESULT
PMID: 21674390 (View on PubMed)

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.

Reference Type RESULT
PMID: 21675354 (View on PubMed)

Other Identifiers

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SCIstemcell

Identifier Type: -

Identifier Source: org_study_id