Deficit-specific Training in Spinal Disorders
Primary Purpose
Spinal Cord Injuries, Multiple Sclerosis, Gait Disorders, Neurologic
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Gait training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
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
Sites / Locations
- Universitätsklinik BalgristRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Deficit-oriented training group
Non-specific, standardised walking training group
Arm Description
Outcomes
Primary Outcome Measures
Six minute walk test (6MWT)
Secondary Outcome Measures
MS-patients: Expanded disability status scale (EDSS)
neurological score, range from 0 to 10, lower values better than higher values
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.
SCI-patients: Walking index for Spinal Cord Injury (WISCI II)
Range from 0-20, higher values are better than lower values.
MS-/ SCI-patients: Six-minute walk test (6MWT)
MS-patients. Timed 25-foot walk (T25FW)
SCI-patients: Timed 10-meter walk test (10MWT)
MS-/ SCI-patients: Timed up and go test (TUG)
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.
MS-/ SCI-patients: Kinetic measures
A set of key kinetic parameters will be quantified describing forces of weight loading for both feet using pedobarography.
MS-/ SCI-patients: Electromyographic measures
EMG measures include timing of leg muscle activity during walking on treadmill.
MS-/ SCI-patients: 12-item WS for walking function (questionnaire)
Questionnaire, range from 12-60 points, lower values are better than higher values.
MS-/ SCI-patients: Time to swim 10m
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.
MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)
MS-/ SCI-patients: Magnetic resonance imaging (MRI)
MS-/ SCI-patients: Magnetic resonance spectroscopy (MRS)
MS-/ SCI-patients: over ground gait kinematics during clinical walking tests (activity sensors)
Full Information
NCT ID
NCT04292717
First Posted
February 20, 2020
Last Updated
August 24, 2023
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04292717
Brief Title
Deficit-specific Training in Spinal Disorders
Official Title
Precision Medicine in the Rehabilitation of Locomotor Function: Individual Gait Profiles for Deficit-specific Training Strategies in Spinal Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Multiple Sclerosis, Gait Disorders, Neurologic, Training, Neurorehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deficit-oriented training group
Arm Type
Active Comparator
Arm Title
Non-specific, standardised walking training group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six minute walk test (6MWT)
Time Frame
Change from screening at 10 weeks
Secondary Outcome Measure Information:
Title
MS-patients: Expanded disability status scale (EDSS)
Description
neurological score, range from 0 to 10, lower values better than higher values
Time Frame
Change from screening at 10 weeks
Title
SCI-patients: ISNCSCI by the American Spinal Injury Association (ASIA protocol)
Description
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.
Time Frame
Change from screening at 10 weeks
Title
SCI-patients: Walking index for Spinal Cord Injury (WISCI II)
Description
Range from 0-20, higher values are better than lower values.
Time Frame
Change from screening at 10 weeks
Title
MS-/ SCI-patients: Six-minute walk test (6MWT)
Time Frame
10 weeks
Title
MS-patients. Timed 25-foot walk (T25FW)
Time Frame
Change from screening at 10 weeks
Title
SCI-patients: Timed 10-meter walk test (10MWT)
Time Frame
Change from screening at 10 weeks
Title
MS-/ SCI-patients: Timed up and go test (TUG)
Time Frame
Change from screening at 10 weeks
Title
MS-/ SCI-patients: Kinematic measures on treadmill
Description
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.
Time Frame
Change from screening at 6 and 10 weeks
Title
MS-/ SCI-patients: Kinetic measures
Description
A set of key kinetic parameters will be quantified describing forces of weight loading for both feet using pedobarography.
Time Frame
Change from screening at 6 and 10 weeks
Title
MS-/ SCI-patients: Electromyographic measures
Description
EMG measures include timing of leg muscle activity during walking on treadmill.
Time Frame
Change from screening at 6 and 10 weeks
Title
MS-/ SCI-patients: 12-item WS for walking function (questionnaire)
Description
Questionnaire, range from 12-60 points, lower values are better than higher values.
Time Frame
Change from baseline at 10 weeks
Title
MS-/ SCI-patients: Time to swim 10m
Time Frame
Change from baseline at 6 weeks
Title
MS-/ SCI-patients: Kinematic parameters of leg movements during swimming (activity sensors)
Description
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.
Time Frame
Change from baseline at 6 weeks
Title
MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)
Time Frame
Change from screening at 10 weeks
Title
MS-/ SCI-patients: Magnetic resonance imaging (MRI)
Time Frame
Change from baseline at 10 weeks
Title
MS-/ SCI-patients: Magnetic resonance spectroscopy (MRS)
Time Frame
Change from baseline at 10 weeks
Title
MS-/ SCI-patients: over ground gait kinematics during clinical walking tests (activity sensors)
Time Frame
Change from baseline at 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Zörner, PD Dr.
Phone
+41 44 386 11 11
Email
bjoern.zoerner@balgrist.ch
Facility Information:
Facility Name
Universitätsklinik Balgrist
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Zörner, PD Dr.
Phone
+41 44 386 11 11
Email
bjoern.zoerner@balgrist.ch
12. IPD Sharing Statement
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Deficit-specific Training in Spinal Disorders
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