Deficit-specific Training in Spinal Disorders

NCT ID: NCT04292717

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-11-19

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Deficit-oriented training group

Group Type: ACTIVE_COMPARATOR

Gait training

Intervention Type: 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.

Non-specific, standardised walking training group

Group Type: ACTIVE_COMPARATOR

Gait training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2020-00247

Identifier Type: -

Identifier Source: org_study_id