motor incomplete, traumatic, chronic (> 1 year after trauma) spinal cord injured individuals G82
Conditions
Interventions
Group 1: 5 therapy sessions per week each lasting 40 min. with the novel locomotion trainer. Overall therapy period of 8 weeks. Assessment of the gait capabilities before, directly after and 3 months
Sponsors
Stiftung Orthopädische Universitätsklinik; Abteilung Orthopädie II
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: motor incomplete spinal cord injury; time after trauma between 1 and 5 years; age between 18 and 60; traumatic, haemorrhagic spinal cord injury or spinal cord injury after disc herniation; Walking Index for Spinal Cord Injury >= 5 (basic walking function)
Exclusion criteria
Exclusion criteria: body weight > 130kg; body height > 200cm; leg length discrepancy > 2 cm; moderate to severe contractures of hip, knee and ankle joints (> 20% of the normal range of motion); severe osteoporosis in the legs; instable fractures, open injuries or pressure sores at the trunk or lower extremities; extreme spasticity; cardiovascular, pulmonary, metabolic or additional orthopedic diseases that additionally restrict the walking function; severe depression; non-neglectable (> 15%) changes in baseline parameters (signs of neurological recovery); WISCI > 20 and one-leg stand possible for min. 3 sec bilaterally (already normal walking function)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary variables are the number of device related adverse events as marker of the safety of the device and tests for direct quantification of the walking capabilities i.e., changes in the 10 Meter Timed Walk Test, im Timed-up-and-go Test, in the 6.-Min. Walk Test and in the SCI Functional Abulation Inventory (SCI-FAI) between baseline and end of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sekondary variables are the motor and sensory ASIA (American Spinal Injury Association)-Scores for quatification of changes in the neurological status and the modifies Ashworth-Scale for classification of changes in the spasticity between baseline and theray end. Additionally, changes in the WISCI II, subjective patient reported changes in walking function and changes in quality of life (Münchner Lebensqualitäts-Dimensionen Liste - MLDL) are documented. By analyzing the status at a follow-up examination 3 months after end of therapy it will be possible to determine, if improvements will get lost after end of therapy or if they will continue after the therapy. | — |
Countries
Germany
Contacts
Public ContactRüdiger Rupp
Stiftung Orthopädische Universitätsklinik; Abteilung Orthopädie II
Outcome results
None listed