Clinical trial NCT04292717: Deficit-specific Training in Spinal Disorders
Official title: Precision Medicine in the Rehabilitation of Locomotor Function: Individual Gait Profiles for Deficit-specific Training Strategies in Spinal Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Multiple Sclerosis
Gait Disorders, Neurologic
Training
Neurorehabilitation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2020-03-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Diagnosis of chronic spinal cord injury (\>6 months cervical or thoracic motor incomplete traumatic or non-traumatic (AIS C, D) above T12 or diagnosis of either primary- progressive, secondary-progressive, or relapsing-remitting multiple sclerosis as defined by the revised McDonald criteria for at least 3 months and with at least one spinal cord lesion as verified in clinical MRI images
* Able to walk without assistance or devices on the treadmill and 10m over ground, but must have impaired walking function as demonstrated by neurological examination.

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Current orthopaedic problems of lower limbs
* History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
* History of major pulmonary condition (e.g., chronic obstructive pulmonary disease GOLD II-IV)
* Current major depression or psychosis
* MS exacerbation within 3 months prior to the screening or at any time during the screening period
* Participation in another training study

Primary outcomes:
measure: Six minute walk test (6MWT)
timeFrame: Change from screening at 10 weeks
Secondary outcomes:
measure: MS-patients: Expanded disability status scale (EDSS)
timeFrame: Change from screening at 10 weeks
measure: SCI-patients: ISNCSCI by the American Spinal Injury Association (ASIA protocol)
timeFrame: Change from screening at 10 weeks
measure: SCI-patients: Walking index for Spinal Cord Injury (WISCI II)
timeFrame: Change from screening at 10 weeks
measure: MS-/ SCI-patients: Six-minute walk test (6MWT)
timeFrame: 10 weeks
measure: MS-patients. Timed 25-foot walk (T25FW)
timeFrame: Change from screening at 10 weeks
measure: SCI-patients: Timed 10-meter walk test (10MWT)
timeFrame: Change from screening at 10 weeks
measure: MS-/ SCI-patients: Timed up and go test (TUG)
timeFrame: Change from screening at 10 weeks
measure: MS-/ SCI-patients: Kinematic measures on treadmill
timeFrame: Change from screening at 6 and 10 weeks
measure: MS-/ SCI-patients: Kinetic measures
timeFrame: Change from screening at 6 and 10 weeks
measure: MS-/ SCI-patients: Electromyographic measures
timeFrame: Change from screening at 6 and 10 weeks
measure: MS-/ SCI-patients: 12-item WS for walking function (questionnaire)
timeFrame: Change from baseline at 10 weeks
measure: MS-/ SCI-patients: Time to swim 10m
timeFrame: Change from baseline at 6 weeks
measure: MS-/ SCI-patients: Kinematic parameters of leg movements during swimming (activity sensors)
timeFrame: Change from baseline at 6 weeks
measure: MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)
timeFrame: Change from screening at 10 weeks
measure: MS-/ SCI-patients: Magnetic resonance imaging (MRI)
timeFrame: Change from baseline at 10 weeks
measure: MS-/ SCI-patients: Magnetic resonance spectroscopy (MRS)
timeFrame: Change from baseline at 10 weeks
measure: MS-/ SCI-patients: over ground gait kinematics during clinical walking tests (activity sensors)
timeFrame: Change from baseline at 10 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
References: