Robotic Gait Training VS.Conventional Rehabilitation in SCI

July 15, 2012 updated by: Ratanapat Chanubol, Prasat Neurological Institute

Robotic Gait Training VS. Conventional Physical Therapy in Spinal Cord Injury Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Ratanapat Chanubol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wernig scale
Time Frame: 4 weeks.
Walking ability classification in spinal cord injury patients.
4 weeks.
Barthel index
Time Frame: 4 weeks.
Measure activity of daily living
4 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prasat Neurological Institute

Collaborators

Mahidol University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

September 10, 2011

First Submitted That Met QC Criteria

September 10, 2011

First Posted (ESTIMATE)

September 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 15, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCIstemcell

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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