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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
63
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.
Universitätsklinik Balgrist
Zurich, Switzerland
Six minute walk test (6MWT)
Time frame: Change from screening at 10 weeks
MS-patients: Expanded disability status scale (EDSS)
neurological score, range from 0 to 10, lower values better than higher values
Time frame: Change from screening at 10 weeks
SCI-patients: ISNCSCI by the American Spinal Injury Association (ASIA protocol)
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
SCI-patients: Walking index for Spinal Cord Injury (WISCI II)
Range from 0-20, higher values are better than lower values.
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Six-minute walk test (6MWT)
Time frame: 10 weeks
MS-patients. Timed 25-foot walk (T25FW)
Time frame: Change from screening at 10 weeks
SCI-patients: Timed 10-meter walk test (10MWT)
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Timed up and go test (TUG)
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Kinematic measures on treadmill
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
MS-/ SCI-patients: Kinetic measures
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
MS-/ SCI-patients: Electromyographic measures
EMG measures include timing of leg muscle activity during walking on treadmill.
Time frame: Change from screening at 6 and 10 weeks
MS-/ SCI-patients: 12-item WS for walking function (questionnaire)
Questionnaire, range from 12-60 points, lower values are better than higher values.
Time frame: Change from baseline at 10 weeks
MS-/ SCI-patients: Time to swim 10m
Time frame: Change from baseline at 6 weeks
MS-/ SCI-patients: Kinematic parameters of leg movements during swimming (activity sensors)
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 baseline at 6 weeks
MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Magnetic resonance imaging (MRI)
Time frame: Change from baseline at 10 weeks
MS-/ SCI-patients: Magnetic resonance spectroscopy (MRS)
Time frame: Change from baseline at 10 weeks
MS-/ SCI-patients: over ground gait kinematics during clinical walking tests (activity sensors)
Time frame: Change from baseline at 10 weeks
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