NCT01432990

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

3.9 years

First QC Date

September 10, 2011

Last Update Submit

July 15, 2012

Conditions

Spinal Cord Injury

Keywords

SCIgaitrehabilitationrobotic

Outcome Measures

Primary Outcomes (2)

  • Wernig scale

    Walking ability classification in spinal cord injury patients.

    4 weeks.

  • Barthel index

    Measure activity of daily living

    4 weeks.

Secondary Outcomes (4)

  • Repas

    4 weeks.

  • Manual muscle testing

    4 weeks

  • 10 meter walking test

    4 weeks.

  • 6 minute walking test

    4 weeks

Study Arms (2)

robotic gait training

EXPERIMENTAL

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

Device: Robot gait training

control

NO INTERVENTION

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

Other: control

Interventions

Robot gait trainingDEVICE

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.

Also known as: Gait trainer GT1
robotic gait training
controlOTHER

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

control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous injury or other neurological condition that related to neurodeficit in key muscles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ratanapat Chanubol

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 21625239BACKGROUND

  • 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.

    PMID: 17213237RESULT

  • 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.

    PMID: 21674390RESULT

  • 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.

    PMID: 21675354RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Ratanapat Chanubol, MD.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 10, 2011

First Posted

September 13, 2011

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

TH(1)