Back to resultsEffectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Locomotor training using a robotic device
Locomotor training using a robotic device
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Locomotor training, Dose-Response
Eligibility 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
Sites / Locations
- Berufsgenossenschaftliche Unfallklinik Murnau
- Institut Guttmann
- Hospital Nacional de Parapléjicos
- Balgrist University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Intensive training
Standard training
Arm Description
Locomotor training using a robotic device of at least 50 minutes
Locomotor training using a robotic device of maximally 25 minutes
Outcomes
Primary Outcome Measures
Ten meter walking test
Self selected walking speed over a distance of 10m
Secondary Outcome Measures
Walking Index for Spinal Cord Injury (WISCI)
Classification of walking ability on a rank ordered scale with 21 categories.
Spasticity
Muscle tone is rated using the modified Ashworth and the Pess spasm frequency tests
Perceived exertion
Spinal Cord Independence Measure
Spinal cord injury classification
Classification according to the standards by the American Spinal Cord Injury Association (ASIA)
Patients' Global Impression of Change Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01147185
Brief Title
Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
Official Title
Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Locomotor training, Dose-Response
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive training
Arm Type
Other
Arm Description
Locomotor training using a robotic device of at least 50 minutes
Arm Title
Standard training
Arm Type
Active Comparator
Arm Description
Locomotor training using a robotic device of maximally 25 minutes
Intervention Type
Device
Intervention Name(s)
Locomotor training using a robotic device
Other Intervention Name(s)
Lokomat, Hocoma AG, Volketswil/Switzerland
Intervention Description
50min walking time, 3-5 trainings/week.
Intervention Type
Device
Intervention Name(s)
Locomotor training using a robotic device
Other Intervention Name(s)
Lokomat, Hocoma AG, Volketswil/Switzerland
Intervention Description
25min walking time, 3-5 trainings/week.
Primary Outcome Measure Information:
Title
Ten meter walking test
Description
Self selected walking speed over a distance of 10m
Time Frame
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Secondary Outcome Measure Information:
Title
Walking Index for Spinal Cord Injury (WISCI)
Description
Classification of walking ability on a rank ordered scale with 21 categories.
Time Frame
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Title
Spasticity
Description
Muscle tone is rated using the modified Ashworth and the Pess spasm frequency tests
Time Frame
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Title
Perceived exertion
Time Frame
after every training
Title
Spinal Cord Independence Measure
Time Frame
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Title
Spinal cord injury classification
Description
Classification according to the standards by the American Spinal Cord Injury Association (ASIA)
Time Frame
at start of training, at weeks 2, 4, 6, 8, 6 and 24
Title
Patients' Global Impression of Change Scale
Time Frame
At week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Wirz, PT PhD
Organizational Affiliation
Zurich University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berufsgenossenschaftliche Unfallklinik Murnau
City
Murnau
ZIP/Postal Code
82418
Country
Germany
Facility Name
Institut Guttmann
City
Barcelona
Country
Spain
Facility Name
Hospital Nacional de Parapléjicos
City
Toledo
Country
Spain
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21619574
Citation
Wirz M, Bastiaenen C, de Bie R, Dietz V. Effectiveness of automated locomotor training in patients with acute incomplete spinal cord injury: a randomized controlled multicenter trial. BMC Neurol. 2011 May 27;11:60. doi: 10.1186/1471-2377-11-60.
Results Reference
derived
Learn more about this trial
Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
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