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

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ClinicalTrials.gov Identifier: NCT01147185
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Locomotor training using a robotic device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
Study Start Date : February 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
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 Name: 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
25min walking time, 3-5 trainings/week.
Other Name: Lokomat, Hocoma AG, Volketswil/Switzerland


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Perceived exertion [ Time Frame: after every training ]
  4. Spinal Cord Independence Measure [ Time Frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24 ]
  5. 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)

  6. Patients' Global Impression of Change Scale [ Time Frame: At week 8 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147185


Locations
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Germany
Berufsgenossenschaftliche Unfallklinik Murnau
Murnau, Germany, 82418
Spain
Institut Guttmann
Barcelona, Spain
Hospital Nacional de Parapléjicos
Toledo, Spain
Switzerland
Balgrist University Hospital
Zurich, Switzerland, 8008
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Markus Wirz, PT PhD Zurich University of Applied Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01147185    
Other Study ID Numbers: EMSCI-DR
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Keywords provided by University of Zurich:
Spinal Cord Injuries, Locomotor training, Dose-Response
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System