MotionTherapy@Home - baseline study for evaluation of safety and efficacy of a robotic locomotion training device for therapy at home

Not Applicable

• Conditions: motor incomplete, traumatic, chronic (> 1 year after trauma) spinal cord injured individuals; G82; Paraplegia and tetraplegia

• Registration Number: DRKS00005587
• Lead Sponsor: Stiftung Orthopädische Universitätsklinik; Abteilung Orthopädie II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-12-31
• Study Start: 2013-12-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>

Secondary Outcome Measures

Name	Time	Method
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. <br>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.<br>