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Clinical Trials/NCT04292717
NCT04292717CompletedNot Applicable

Precision Medicine in the Rehabilitation of Locomotor Function: Individual Gait Profiles for Deficit-specific Training Strategies in Spinal Disorders

University of Zurich2 sites in 1 country63 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
63
Locations
2
Primary Endpoint
Six minute walk test (6MWT)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Six minute walk test (6MWT)

Time Frame: Change from screening at 10 weeks

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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