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Spinal Cord InjuryPhase 3NCT01432990

Robotic Gait Training VS.Conventional Rehabilitation in SCI

A Phase 3 study testing Robot gait training in people with Spinal Cord Injury, run by Prasat Neurological Institute at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Robot gait training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteThailand
Study dates
Jan 2013to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Ratanapat Chanubol

    Bangkok, Bangkok, 10400

    Ratanapat Chanubol, MD., 662-3547078 ext. 3170, cpaphan@yahoo.com

Other trials in Thailand

About this study

Official title: 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.

Read the detailed description

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

Being tested
Robot gait training, control
Keywords
SCI, gait, rehabilitation, robotic
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot gait trainingDevice

    Also called Gait trainer GT1

    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.

  • controlOther

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

Study groups in NCT01432990
Study groupRoleWhat they receive
robotic gait trainingExperimentalconventional physical therapy plus robot gait training program for SCI patients.
Receives: Device: Robot gait training
controlNo interventionConventional physical therapy program for 60 minute per day for 5 working day per week.
Receives: Other: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wernig scale

    Walking ability classification in spinal cord injury patients.

    Measured: 4 weeks.

  2. Barthel index

    Measure activity of daily living

    Measured: 4 weeks.

Secondary outcomes (4)

  1. Repas

    Spasticity measurement

    Measured: 4 weeks.

  2. Manual muscle testing

    Measure muscle power in each key muscle according to ASIA classification.

    Measured: 4 weeks

  3. 10 meter walking test

    If patients can walk, measure speed of walking with step length.

    Measured: 4 weeks.

  4. 6 minute walking test

    If patient can walk, measure endurance.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2011 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01432990
Sponsor's protocol ID
SCIstemcell
Status last verified
Jul 2012
First submitted
10 Sep 2011
Last updated
17 Jul 2012
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 21625239

  • 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.

    PubMed 17213237

  • 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.

    PubMed 21674390

  • 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.

    PubMed 21675354

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Robot gait training in people with Spinal Cord Injury, run by Prasat Neurological Institute at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wernig scale (time frame: 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01432990, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.

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