Spinal Cord Injuries
Conditions
Keywords
Spinal Cord Injuries, Locomotor training, Dose-Response
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.
Interventions
DEVICELocomotor training using a robotic device
50min walking time, 3-5 trainings/week.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ten meter walking test | at start of training, at weeks 2, 4, 6, 8, 6 and 24 | Self selected walking speed over a distance of 10m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Independence Measure | at start of training, at weeks 2, 4, 6, 8, 6 and 24 | — |
| Walking Index for Spinal Cord Injury (WISCI) | 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. |
| Perceived exertion | after every training | — |
| Spinal cord injury classification | 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) |
| Patients' Global Impression of Change Scale | At week 8 | — |
| Spasticity | 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 |
Countries
Germany, Spain, Switzerland
Outcome results
None listed