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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive training | Other | Locomotor training using a robotic device of at least 50 minutes |
|
| Standard training | Active Comparator | Locomotor training using a robotic device of maximally 25 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locomotor training using a robotic device | Device | 50min walking time, 3-5 trainings/week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ten meter walking test | Self selected walking speed over a distance of 10m | at start of training, at weeks 2, 4, 6, 8, 6 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Index for Spinal Cord Injury (WISCI) | 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 | Muscle tone is rated using the modified Ashworth and the Pess spasm frequency tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Wirz, PT PhD | Zurich University of Applied Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berufsgenossenschaftliche Unfallklinik Murnau | Murnau am Staffelsee | 82418 | Germany | |||
| Institut Guttmann |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21619574 | Derived | 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. |
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| Locomotor training using a robotic device | Device | 25min walking time, 3-5 trainings/week. |
|
|
| at start of training, at weeks 2, 4, 6, 8, 6 and 24 |
| Perceived exertion | after every training |
| Spinal Cord Independence Measure | at start of training, at weeks 2, 4, 6, 8, 6 and 24 |
| Spinal cord injury classification | 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 | At week 8 |
| Barcelona |
| Spain |
| Hospital Nacional de Parapléjicos | Toledo | Spain |
| Balgrist University Hospital | Zurich | 8008 | Switzerland |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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