Spinal Cord DiseasesNCT03534518
Body Weight Supported Training Study
A study testing BWS overground training and BWS treadmill training in people with Spinal Cord Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
Successful ambulation at home and in the community is the main goal of gait training after incomplete spinal cord injury. Many different treatment approaches have been recommended to achieve this goal. One established intervention to achieve that in a clinical setting is body weight supported (BWS) treadmill training. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Diseases
- What is being tested?
- BWS overground training and BWS treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2019to 8 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Chronic spinal cord injury (>6 months)
- Incomplete traumatic or non-traumatic lesion (AIS C, D) above T12
- Able to walk 10m with or without walking devices or physical assistance
- Mini-Mental state examination score ³26 (test will only be performed if cognitive deficits are suspected)
Who cannot join
- Walking capacity > 500m in 6mWT
- Current orthopaedic problems
- History of cardiac condition
- Epilepsy
- Potential pregnancy (pregnancy test must be conducted before
- Each neurophysiological testing)Pressure sore stage 2 or higher, located where a harness could affect healing
Show all 10Show fewer
- Premorbid major depression or psychosis
- Unlikely to complete the intervention or return for follow-up
- Participation in another training study
- Body weight > 120kg
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Body Weight Supported Overground Gait Training to Promote Recovery of Walking Function in Chronic Spinal Cord Injury: a Randomized Clinical Trial
Successful ambulation at home and in the community is the main goal of gait training after incomplete spinal cord injury. Many different treatment approaches have been recommended to achieve this goal. One established intervention to achieve that in a clinical setting is body weight supported (BWS) treadmill training. However, recent studies have suggested that the most optimal gait training should be conducted overground with appropriate support conditions to enable a physiological gait pattern. The training has to be challenging and patients must participate as active as possible.
In addition becoming a functional walker in real world involves a variety of walking skills like walking on uneven surfaces, walking up and down slopes, climbing stairs and avoid obstacles. It has been shown in humans as well as in animals that greater improvements are achieved in walking function if the training is task specific. Thus a constrained task like BWS treadmill training may not be the optimal training intervention to become a functional community walker.
Read more
Even greater improvements can be expected if patients feel safe during the overground walking and train at their individual limits. With FLOAT there is now the possibility to conduct a task specific BWS overground gait training in a safe environment. The robotic device allows patients to perform different walking tasks like walking overground, avoiding obstacles, walking on uneven and sloped surfaces, climbing stairs, walking in narrow spaces. A virtual reality setup was integrated into the system that even can simulate specific walking tasks like target oriented walking or walking in crowded environment. Based on the promising results seen in preclinical and clinical research, the investigators assume that unrestricted transparent BWS overground training that allows task specific training of real world walking tasks will induce greater improvements than conventional BWS treadmill training.
The investigators will compare the effect of an intensive 4 weeks unrestricted BWS overground gait training to 4 weeks of intensive BWS treadmill training. Not only functional outcome like walking speed or capacity will be assessed but also detailed kinematics that will help to identify the mechanisms of the underlying improvements in walking function.
- Conditions
- Spinal Cord Diseases
- Being tested
- BWS overground training, BWS treadmill training
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWS overground trainingOther
BWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. The walking tasks will be roughly divided into different domains like skilled walking, balance, dual tasking, walking speed, walking endurance.
BWS treadmill trainingOther
Training will be conducted on a standard treadmill with an overhead BWS system that can provide active BWS. Participants are allowed to hold the rails but weight bearing is not allowed. BWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. Main walking tasks will be endurance (walking long distances at preferred speed) and speed (walking at maximal possible speed).
| Study group | Role | What they receive |
|---|---|---|
| SCI-patients receiving overground training | Active comparator | Not described Receives: Other: BWS overground training |
| SCI-patients receiving treadmill training | Active comparator | Not described Receives: Other: BWS treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Measured: Change from day 0 at day 28 and at day 56-63 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Mar 2019
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534518
- Sponsor's protocol ID
- 2018-00811
- Other IDs
- 2018
- Status last verified
- Sep 2023
- First submitted
- 7 May 2018
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Weight Supported Overground Gait Training to Promote Recovery of Walking Function in Chronic Spinal Cord Injury: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03534518
- Acronym / sponsor ID
- 2018-00811
- Conditions
- Spinal Cord Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Foundation Wings For Life
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 23 May 2018 (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.
Successful ambulation at home and in the community is the main goal of gait training after incomplete spinal cord injury. Many different treatment approaches have been recommended to achieve this goal. One established intervention to achieve that in a clinical setting is body weight supported (BWS) treadmill training. However, recent studies have suggested that the most optimal gait training should be conducted overground with appropriate support conditions to enable a physiological gait pattern. The training has to be challenging and patients must participate as active as possible.
In addition becoming a functional walker in real world involves a variety of walking skills like walking on uneven surfaces, walking up and down slopes, climbing stairs and avoid obstacles. It has been shown in humans as well as in animals that greater improvements are achieved in walking function if the training is task specific. Thus a constrained task like BWS treadmill training may not be the optimal training intervention to become a functional community walker.
Even greater improvements can be expected if patients feel safe during the overground walking and train at their individual limits. With FLOAT there is now the possibility to conduct a task specific BWS overground gait training in a safe environment. The robotic device allows patients to perform different walking tasks like walking overground, avoiding obstacles, walking on uneven and sloped surfaces, climbing stairs, walking in narrow spaces. A virtual reality setup was integrated into the system that even can simulate specific walking tasks like target oriented walking or walking in crowded environment. Based on the promising results seen in preclinical and clinical research, the investigators assume that unrestricted transparent BWS overground training that allows task specific training of real world walking tasks will induce greater improvements than conventional BWS treadmill training.
The investigators will compare the effect of an intensive 4 weeks unrestricted BWS overground gait training to 4 weeks of intensive BWS treadmill training. Not only functional outcome like walking speed or capacity will be assessed but also detailed kinematics that will help to identify the mechanisms of the underlying improvements in walking function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI-patients receiving overground training | Active comparator | Other: BWS overground training |
| SCI-patients receiving treadmill training | Active comparator | Other: BWS treadmill training |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years
- Chronic spinal cord injury (>6 months)
- Incomplete traumatic or non-traumatic lesion (AIS C, D) above T12
- Able to walk 10m with or without walking devices or physical assistance
- Mini-Mental state examination score ³26 (test will only be performed if cognitive deficits are suspected)
Key exclusion criteria (10 listed)
- Walking capacity > 500m in 6mWT
- Current orthopaedic problems
- History of cardiac condition
- Epilepsy
- Potential pregnancy (pregnancy test must be conducted before
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 |
|---|---|---|
| BWS overground trainingBWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. The walking tasks will be roughly divided into different domains like skilled walking, balance, dual tasking, walking speed, walking endurance. | Other | SCI-patients receiving overground training |
| BWS treadmill trainingTraining will be conducted on a standard treadmill with an overhead BWS system that can provide active BWS. Participants are allowed to hold the rails but weight bearing is not allowed. BWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. Main walking tasks will be endurance (walking long distances at preferred speed) and speed (walking at maximal possible speed). | Other | SCI-patients receiving treadmill training |
Primary outcome
Timed Up and Go (TUG)
Time frame: Change from day 0 at day 28 and at day 56-63 (follow-up)
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 Sep 2025.
- Individual participant dataSharing planned: No
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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 BWS overground training and BWS treadmill training in people with Spinal Cord Diseases, 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 5 inclusion and 10 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 Sep 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?
Timed Up and Go (TUG) (time frame: Change from day 0 at day 28 and at day 56-63 (follow-up)). 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 Sep 2025.