Spinal Cord InjuryNCT02425332
Validation of a Novel Robot-aided Assessment of Gait Ability
A study testing Lokomat gait trainer in people with Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Lokomat gait trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Nov 2016
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals >1 year post Spinal Cord Injury or able bodied persons
Who cannot join
- presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Lokomat-aided Assessment of Gait Ability
The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.
- Conditions
- Spinal Cord Injury
- Being tested
- Lokomat gait trainer
- Keywords
- Spinal Cord Injury, adaptive control, assessment, assist-as-needed, walking ability, Lokomat
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat gait trainerDevice
| Study group | Role | What they receive |
|---|---|---|
| Lokomat assessment | Experimental | Not described Receives: Device: Lokomat gait trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass Correlation Coefficient between Lokomat score.
Reliability of Lokomat assessment
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425332
- Sponsor's protocol ID
- KEK-ZH-2015 0020/PB_2016-00466
- Status last verified
- Dec 2017
- First submitted
- 20 Apr 2015
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maggioni S, Lunenburger L, Riener R, Curt A, Bolliger M, Melendez-Calderon A. Assessing walking ability using a robotic gait trainer: opportunities and limitations of assist-as-needed control in spinal cord injury. J Neuroeng Rehabil. 2023 Sep 21;20(1):121. doi: 10.1186/s12984-023-01226-4.
PubMed 37735690
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Lokomat-aided Assessment of Gait Ability
- ClinicalTrials.gov ID
- NCT02425332
- Acronym / sponsor ID
- KEK-ZH-2015 0020/PB_2016-00466
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, adaptive control, assessment, assist-as-needed, walking ability, Lokomat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Apr 2015 (estimated)
- 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.
The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lokomat assessment | Experimental | Device: Lokomat gait trainer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- individuals >1 year post Spinal Cord Injury or able bodied persons
Key exclusion criteria (1 listed)
- presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures
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 |
|---|---|---|
| Lokomat gait trainer | Device | Lokomat assessment |
Primary outcome
Intraclass Correlation Coefficient between Lokomat score.
Time frame: up to one week
Reliability of Lokomat assessment
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 19 Dec 2017.
- Derived from this study: PubMed 37735690Maggioni S, Lunenburger L, Riener R, Curt A, Bolliger M, Melendez-Calderon A. Assessing walking ability using a robotic gait trainer: opportunities and limitations of assist-as-needed control in spinal cord injury. J Neuroeng Rehabil. 2023 Sep 21;20(1):121. doi: 10.1186/s12984-023-01226-4.
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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 Lokomat gait trainer in people with Spinal Cord Injury, 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 1 inclusion and 1 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 19 Dec 2017. 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?
Intraclass Correlation Coefficient between Lokomat score. (time frame: up to one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425332, which also lists 1 linked publication.
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 19 Dec 2017.