Deficit-specific Training in Spinal Disorders

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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Training; Spinal Cord Injuries; Gait Disorders, Neurologic; Neurorehabilitation
• Intervention / Treatment: Behavioral: Gait training

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Universitätsklinik Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Deficit-oriented training group	Behavioral: Gait training; 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.
Active Comparator: Non-specific, standardised walking training group	Behavioral: Gait training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Six minute walk test (6MWT)	Change from screening at 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MS-patients: Expanded disability status scale (EDSS)	neurological score, range from 0 to 10, lower values better than higher values	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.	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.	Change from screening at 10 weeks
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: Timed up and go test (TUG)		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.	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.	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.	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)	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.	Change from baseline at 6 weeks
MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)		Change from screening at 10 weeks
MS-/ SCI-patients: Magnetic resonance imaging (MRI)		Change from baseline at 10 weeks
MS-/ SCI-patients: Magnetic resonance spectroscopy (MRS)		Change from baseline at 10 weeks
MS-/ SCI-patients: over ground gait kinematics during clinical walking tests (activity sensors)		Change from baseline at 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.	Change from baseline at 10 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss National Science Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 19, 2025
• Study Completion (Actual): November 19, 2025

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Trauma, Nervous System; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Multiple Sclerosis; Spinal Cord Injuries; Gait Disorders, Neurologic
• Other Study ID Numbers: 2020-00247

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No