Deficit-specific Training in Spinal Disorders

Not Applicable

Recruiting

• Conditions: Gait Disorders, Neurologic; Spinal Cord Injuries; Multiple Sclerosis; Training; Neurorehabilitation
• Interventions: Behavioral: Gait training

• Registration Number: NCT04292717
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-03
• Study Start: 2021-01-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-specific, standardised walking training group	Gait training	-
Deficit-oriented training group	Gait training	-

Primary Outcome Measures

Name	Time	Method
Six minute walk test (6MWT)	Change from screening at 10 weeks

Secondary Outcome Measures

Name	Time	Method
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	EMG measures include timing of leg muscle activity during walking on treadmill.
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	Questionnaire, range from 12-60 points, lower values are better than higher values.
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	Range from 0-20, higher values are better than lower values.
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	neurological score, range from 0 to 10, lower values better than higher values
MS-/ SCI-patients: Kinetic measures	Change from screening at 6 and 10 weeks	A set of key kinetic parameters will be quantified describing forces of weight loading for both feet using pedobarography.
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	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.
MS-/ SCI-patients: Kinematic measures on treadmill	Change from screening at 6 and 10 weeks	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.
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	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.
MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)	Change from screening at 10 weeks

Trial Locations

Locations (1)

Universitätsklinik Balgrist; 🇨🇭 Zürich, Switzerland