Deficit-specific Training in Spinal Disorders

NCT04292717 | Completed

• 1 other identifier: 2020-00247
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Multiple Sclerosis; Gait Disorders, Neurologic; Training; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Six minute walk test (6MWT)

  Change from screening at 10 weeks

Secondary Outcomes (17)

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

  Change from screening at 10 weeks

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

  Change from screening at 10 weeks

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

  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

Study Arms (2)

Deficit-oriented training group

ACTIVE COMPARATOR

Behavioral: Gait training

Non-specific, standardised walking training group

ACTIVE COMPARATOR

Behavioral: Gait training

Interventions

Gait training BEHAVIORAL

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.

Deficit-oriented training group; Non-specific, standardised walking training group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Multiple Sclerosis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 3, 2020
• Study Start: January 1, 2021
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CH (1)