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

CompletedNot a drug-phase studyRelapsing and progressiveNCT04292717

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Gait training

What it measured

Main measures

  • Six minute walk test (6MWT)

    Change from screening at 10 weeks

    Walking and mobility

Other measures (17)

  • MS-patients: Expanded disability status scale (EDSS)

    Change from screening at 10 weeks

    Disability progression
  • SCI-patients: ISNCSCI by the American Spinal Injury Association (ASIA protocol)

    Change from screening at 10 weeks

    Physical function
  • SCI-patients: Walking index for Spinal Cord Injury (WISCI II)

    Change from screening at 10 weeks

    Walking and mobility
  • MS-/ SCI-patients: Six-minute walk test (6MWT)

    10 weeks

    Walking and mobility
  • MS-patients. Timed 25-foot walk (T25FW)

    Change from screening at 10 weeks

    Disability progressionWalking and mobility
  • SCI-patients: Timed 10-meter walk test (10MWT)

    Change from screening at 10 weeks

    Walking and mobility
  • MS-/ SCI-patients: Timed up and go test (TUG)

    Change from screening at 10 weeks

    Walking and mobility
  • MS-/ SCI-patients: Kinematic measures on treadmill

    Change from screening at 6 and 10 weeks

    Walking and mobility
  • MS-/ SCI-patients: Kinetic measures

    Change from screening at 6 and 10 weeks

  • MS-/ SCI-patients: Electromyographic measures

    Change from screening at 6 and 10 weeks

    Walking and mobility

Who could take part

Relapsing and progressive · 18 to 80

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Jan 2021

    2. Main results due

      Nov 2025

    3. Finished

      Nov 2025

    Assembled by software from public sources.