Spinal Cord InjuriesNCT04292717
Deficit-specific Training in Spinal Disorders
A study testing Gait training in people with Spinal Cord Injuries and Multiple Sclerosis, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Multiple Sclerosis, Gait Disorders, Neurologic
- What is being tested?
- Gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Gait Disorders, Neurologic, Training, Neurorehabilitation
- Being tested
- Gait training
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Deficit-oriented training group | Active comparator | Not described Receives: Behavioral: Gait training |
| Non-specific, standardised walking training group | Active comparator | Not described Receives: Behavioral: Gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test (6MWT)
Measured: Change from screening at 10 weeks
Secondary outcomes (17)
MS-patients: Expanded disability status scale (EDSS)
neurological score, range from 0 to 10, lower values better than higher values
Measured: 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.
Measured: 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.
Measured: Change from screening at 10 weeks
MS-/ SCI-patients: Six-minute walk test (6MWT)
Measured: 10 weeks
MS-patients. Timed 25-foot walk (T25FW)
Measured: Change from screening at 10 weeks
SCI-patients: Timed 10-meter walk test (10MWT)
Measured: Change from screening at 10 weeks
MS-/ SCI-patients: Timed up and go test (TUG)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from screening at 6 and 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.
Measured: Change from baseline at 10 weeks
MS-/ SCI-patients: Time to swim 10m
Measured: 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.
Measured: Change from baseline at 6 weeks
MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)
Measured: Change from screening at 10 weeks
MS-/ SCI-patients: Magnetic resonance imaging (MRI)
Measured: Change from baseline at 10 weeks
MS-/ SCI-patients: Magnetic resonance spectroscopy (MRS)
Measured: Change from baseline at 10 weeks
MS-/ SCI-patients: over ground gait kinematics during clinical walking tests (activity sensors)
Measured: Change from baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jan 2021
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292717
- Sponsor's protocol ID
- 2020-00247
- Status last verified
- Nov 2025
- First submitted
- 20 Feb 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine in the Rehabilitation of Locomotor Function: Individual Gait Profiles for Deficit-specific Training Strategies in Spinal Disorders
- ClinicalTrials.gov ID
- NCT04292717
- Acronym / sponsor ID
- 2020-00247
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Gait Disorders, Neurologic, Training, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deficit-oriented training group | Active comparator | Behavioral: Gait training |
| Non-specific, standardised walking training group | Active comparator | Behavioral: Gait training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait trainingAll 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. | Behavioural | Deficit-oriented training group, Non-specific, standardised walking training group |
Primary outcome
Six minute walk test (6MWT)
Time frame: Change from screening at 10 weeks
17 secondary outcomes
MS-patients: Expanded disability status scale (EDSS)
Time frame: Change from screening at 10 weeks
SCI-patients: ISNCSCI by the American Spinal Injury Association (ASIA protocol)
Time frame: Change from screening at 10 weeks
SCI-patients: Walking index for Spinal Cord Injury (WISCI II)
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Six-minute walk test (6MWT)
Time frame: 10 weeks
MS-patients. Timed 25-foot walk (T25FW)
Time frame: Change from screening at 10 weeks
SCI-patients: Timed 10-meter walk test (10MWT)
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Timed up and go test (TUG)
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Kinematic measures on treadmill
Time frame: Change from screening at 6 and 10 weeks
MS-/ SCI-patients: Kinetic measures
Time frame: Change from screening at 6 and 10 weeks
MS-/ SCI-patients: Electromyographic measures
Time frame: Change from screening at 6 and 10 weeks
MS-/ SCI-patients: 12-item WS for walking function (questionnaire)
Time frame: Change from baseline at 10 weeks
MS-/ SCI-patients: Time to swim 10m
Time frame: Change from baseline at 6 weeks
MS-/ SCI-patients: Kinematic parameters of leg movements during swimming (activity sensors)
Time frame: Change from baseline at 6 weeks
MS-/SCI-patients: Spinal Cord Independence Measure (SCIM-III)
Time frame: Change from screening at 10 weeks
MS-/ SCI-patients: Magnetic resonance imaging (MRI)
Time frame: Change from baseline at 10 weeks
MS-/ SCI-patients: Magnetic resonance spectroscopy (MRS)
Time frame: Change from baseline at 10 weeks
MS-/ SCI-patients: over ground gait kinematics during clinical walking tests (activity sensors)
Time frame: Change from baseline at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training in people with Spinal Cord Injuries and Multiple Sclerosis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test (6MWT) (time frame: Change from screening at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.