Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial

June 28, 2016 updated by: University of Zurich
The purpose of this study is to determine whether longer locomotor training results in a mor favorable outcome in patients with incomplete spinal cord injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

About half of patients who experience a traumatic spinal cord injury (SCI) have still motor and/or sensory function below the level of the lesion. A large proportion of these patients become ambulatory within the first six months after the SCI. In order to optimally train the walking function patients are partially unloaded from their body weight while they walk on a moving treadmill. In severe cases therapists have to assist the leg movements which is an exhaustive work limiting training time. In the last few years robotic devices have been developed which enable longer training time. Studies evaluating the training of patients with hemiparesis showed that longer training time is associated with a better outcome. The present study aims at evaluating the effect of training time within the robotic device on the recovery of ambulatory function. Subject with an acute incomplete SCI will be included. The intervention consist of a walking training which lasts at least 50min, the training of the control group last at maximum 25min. Both groups will undergo 3-5 trainings per week. Group assignment will be performed at random. The study lasts for 8 weeks. The primary outcome will be the self selected walking speed which will be assessed bi-weekly during the training period and 4 months later.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

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

  • Germany
      • Murnau, Germany, 82418
        • Berufsgenossenschaftliche Unfallklinik Murnau
  • Spain
      • Barcelona, Spain
        • Institut Guttmann
      • Toledo, Spain
        • Hospital Nacional de Parapléjicos
  • Switzerland
      • Zurich, Switzerland, 8008
        • Balgrist University Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with spinal cord injury (SCI) categorized according to the standard classification of the American Spinal Injury Association as ASIA B or C within the first two weeks after trauma
  • traumatic etiology of SCI
  • limited walking ability (Walking Index for Spinal Cord Injury ≤5)
  • able to start training or rehab within 60 days after trauma
  • motor level between cervical 4 and thoracic 12
  • signed informed consent

Exclusion Criteria:

  • exclusion criteria of the Lokomat:(bodyweight > 130kg, body height > 200cm, leg length diff > 2cm, osteoporosis, instable fracture of lower extremity, restricted range of motion, decubitus ulcer of lower extremity)
  • concomitant injury limiting walking ability (e.g. lower extremity fractures, instable spine fractures, Joint instability preventing weight-bearing, severe soft tissue lesion)
  • pre-existing medical conditions interfering with unrestricted walking (e.g. total joint replacement, pain, osteoarthritis, polyneuropathy, cardiopulmonary disease)
  • age older than 65 years or younger than 18 years
  • conus medullaris or cauda equina syndrome
  • traumatic brain injury
  • passive range of motion of the hips, knees and ankles not sufficient to allow normal kinematics consistent with upright gait
  • patient participates in other rehabilitation or pharmacological study

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intensive training
Locomotor training using a robotic device of at least 50 minutes
Device: Locomotor training using a robotic device
50min walking time, 3-5 trainings/week.
Other Names:
  • Lokomat, Hocoma AG, Volketswil/Switzerland
Device: Locomotor training using a robotic device
25min walking time, 3-5 trainings/week.
Other Names:
  • Lokomat, Hocoma AG, Volketswil/Switzerland
Active Comparator: Standard training
Locomotor training using a robotic device of maximally 25 minutes
Device: Locomotor training using a robotic device
50min walking time, 3-5 trainings/week.
Other Names:
  • Lokomat, Hocoma AG, Volketswil/Switzerland
Device: Locomotor training using a robotic device
25min walking time, 3-5 trainings/week.
Other Names:
  • Lokomat, Hocoma AG, Volketswil/Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ten meter walking test
Time Frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Self selected walking speed over a distance of 10m
at start of training, at weeks 2, 4, 6, 8, 6 and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Index for Spinal Cord Injury (WISCI)
Time Frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Classification of walking ability on a rank ordered scale with 21 categories.
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Spasticity
Time Frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Muscle tone is rated using the modified Ashworth and the Pess spasm frequency tests
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Perceived exertion
Time Frame: after every training
after every training
Spinal Cord Independence Measure
Time Frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Spinal cord injury classification
Time Frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Classification according to the standards by the American Spinal Cord Injury Association (ASIA)
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Patients' Global Impression of Change Scale
Time Frame: At week 8
At week 8

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Markus Wirz, PT PhD, Zurich University of Applied Sciences

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

February 1, 2010

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMSCI-DR

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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