GaitLOKOMATNCT02085954
Evaluation of a Training in the Walking With Exosquelette
An observational study of Gait and Stroke, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait, Stroke, Robotic Rehabilitation
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Dec 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients follow in our rehabilitation hospital, able to walk alone
Who may be able to join
- single stroke
- able to walk alone
- > 18years
Who cannot join
- Cognitive impairments disturbing understanding
- Uncontrolled medical disorder associated
Trial locations and contacts
1 site in 1 country.
About this study
Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.
- Conditions
- Gait, Stroke, Robotic Rehabilitation
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
peak knee flexion (degrees)
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes (3)
hip and ankle kinematics (degrees)
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
kinetics (newton/meter)
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
spatio temporal parameter (m/s)
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085954
- Sponsor's protocol ID
- 12077
- Acronym
- LOKOMAT
- Status last verified
- Oct 2015
- First submitted
- 28 Jan 2014
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Training in the Walking With Exosquelette
- ClinicalTrials.gov ID
- NCT02085954
- Acronym / sponsor ID
- LOKOMAT / 12077
- Conditions
- Gait, Stroke, Robotic Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Mar 2014 (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.
Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients follow in our rehabilitation hospital, able to walk alone
Key inclusion criteria (3 listed)
- single stroke
- able to walk alone
- > 18years
Key exclusion criteria (2 listed)
- Cognitive impairments disturbing understanding
- Uncontrolled medical disorder associated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peak knee flexion (degrees)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
3 secondary outcomes
hip and ankle kinematics (degrees)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
kinetics (newton/meter)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
spatio temporal parameter (m/s)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
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 Mar 2016.
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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?
An observational study of Gait and Stroke, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 2 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 Mar 2016. 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 France. 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?
peak knee flexion (degrees) (time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week). 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 Mar 2016.