Universitätsklinik Balgrist
Zurich, 8008, Switzerland
NCT Number: NCT04292717
Impairments of walking function after spinal cord lesion due to, for example, inflammation, ischemia or trauma are exceptionally diverse. Depending on the size, location and completeness of the spinal cord lesion, gait dysfunction is often multifactorial, arising from weakness of leg muscles, sensory impairments or spasticity. Locomotor function in humans with spinal cord damage can be improved through training. However, there are no evidence-based guidelines for the treatment of gait dysfunctions and no excepted standards of gait training in this large and heterogeneous group of patients. A lack of evidence-based guidance and standardisation prevents the development of optimal training programs for patients with spinal cord damage and rather broad and subjective clinical judgement is applied to determine patient care. Objective and quantitative techniques like three-dimensional (3D) full-body movement analysis capable of identifying the most relevant determinants of gait dysfunction at the single-patient-level are not yet implemented as diagnostic tool to guide physical therapy in this heterogeneous group of patients. The objective of this project is to further advance current clinical locomotor training strategies by applying a deficit-oriented gait training approach based on subject-specific, objective gait profiles gleaned from 3D gait analysis in chronic, mildly to moderately gait-impaired individuals with spinal cord damage due to inflammation (in multiple sclerosis, MS) or with traumatic or ischemic spinal cord injury (SCI; motor incomplete). Within a parallel-group clinical trial, gait impaired subjects will be characterized by detailed kinematic 3D gait analysis and either trained according to their individual deficits or treated with non-specific, standard walking therapy for six weeks. It is hypothesized that individually adapted, deficit-oriented training is superior in improving walking function than purely task-related, ambulatory training in patients with spinal cord damage. This project may pave the way to more efficient training approaches in subjects with spinal cord damage by transferring and implementing modern gait assessment techniques into clinical neurorehabilitation and to move towards individual, patient-tailored locomotor training programs.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Zurich, 8008, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants will receive training three times a week for 6 weeks (18 training sessions) at the University Hospital Balgrist, Spinal Cord Injury Centre. Each exercise session will last for 1 hour and will be conducted and supervised by an experienced physical therapist.
Time frame: Change from screening at 10 weeks
Time frame: Change from screening at 10 weeks
neurological score, range from 0 to 10, lower values better than higher values
Time frame: Change from screening at 10 weeks
Perceptions of light touch (LT) and pinprick (PP) stimuli are scored as 0 for absent, 1 for impaired and 2 for normal (range for sum score for pin prick and light touch: 0-112). Motor function is scored on the Medical Research Council Scale of 0 for total paralysis to 5 for normal strength. Ten muscles are tested bilaterally and individual muscle scores are added together, yielding an ASIA motor score that ranges from 0 to 100. For all assessments higher scores are better than lower scores.
Time frame: Change from screening at 10 weeks
Range from 0-20, higher values are better than lower values.
Time frame: 10 weeks
Time frame: Change from screening at 10 weeks
Time frame: Change from screening at 10 weeks
Time frame: Change from screening at 10 weeks
Time frame: Change from screening at 6 and 10 weeks
A set of key kinematic parameters will be quantified describing leg, trunk and arm movements during walking on a treadmill including range of motion (in degrees) of hip, knee and ankle joints.
Time frame: Change from screening at 6 and 10 weeks
A set of key kinetic parameters will be quantified describing forces of weight loading for both feet using pedobarography.
Time frame: Change from screening at 6 and 10 weeks
EMG measures include timing of leg muscle activity during walking on treadmill.
Time frame: Change from baseline at 10 weeks
Questionnaire, range from 12-60 points, lower values are better than higher values.
Time frame: Change from baseline at 6 weeks
Time frame: Change from baseline at 6 weeks
A set of key kinematic parameters will be quantified describing leg movements during swimming including range of motion (in degrees) of hip, knee and ankle joints.
Time frame: Change from screening at 10 weeks
Time frame: Change from baseline at 10 weeks
Time frame: Change from baseline at 10 weeks
Time frame: Change from baseline at 10 weeks
University of Zurich
Other
Precision Medicine in the Rehabilitation of Locomotor Function: Individual Gait Profiles for Deficit-specific Training Strategies in Spinal Disorders
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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