Post-stroke Gait AssessmentsSUPLOCONCT02263560
Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects
An observational study of Post-stroke Gait Assessments, run by University of Fribourg at 1 site in Switzerland.
Trial summary
Many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Gait Assessments
- What is being tested?
- Kinematic measurements
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Mar 2016
- How long will I take part?
- 1 Year
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The selected patients will be described by following parameters: * Parameters in relation to the person: age, gender. * Parameters in relation to the pathology: NIHSS, exact localisation, time since start of the symptoms, FIM (functional independence measure) visual field (ophthalmological examen), visual acuity (ophtalmological examen), visual neglect (Bells Cancellation Task), visuo-spatial short term working memory (Corsi span), visual motor integration (3-D cub subtest MoCA) * Parameters in relation to hospital stay: length of stay.
Who may be able to join
- Adult male and female subjects (18-->85 years old)
Who cannot join
- Persons with history of an acquired or congenital neurological disorder, e.g. stroke, multiple sclerosis, Parkinson disease, increased intracranial pressure, etc.;
- Persons injured at the time of the experiments (fractures,…);
- Persons having reported repetitive spatial troubles/disorders;
- Persons with eye disorders and non-corrected vision problems;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University (UNIFR) and Hospital of Fribourg (HFR)
Fribourg, 1700
About this study
Many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. In this project, the investigators will study post-stroke gaits of human patients and compare them to those of a control population during a goal-oriented task performed in different visual conditions.
The investigators want to test the hypothesis that during simple goal-oriented locomotor tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express navigational deficits.
- Conditions
- Post-stroke Gait Assessments
- Being tested
- Kinematic measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematic measurementsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Post-stroke patients | Patients who experienced stroke and who already recover gait abilities. Receives: Behavioral: Kinematic measurements | |
| Control population | Participants matching the criterion (age and gender) of the patients' group. Receives: Behavioral: Kinematic measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking stability indices of post-stroke patients
Measured: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
Spatial accuracy of walking trajectories in post-stroke patients
Measured: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Gait AssessmentsStudies 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
- Other
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Titus Bihl, Hopital Cantonal Fribourgeois
- Responsible party
- Principal investigator, Halim HICHEUR, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263560
- Sponsor's protocol ID
- UFribourg
- Acronym
- SUPLOCO
- Status last verified
- Oct 2017
- First submitted
- 6 Oct 2014
- Last updated
- 25 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects
- ClinicalTrials.gov ID
- NCT02263560
- Acronym / sponsor ID
- SUPLOCO / UFribourg
- Conditions
- Post-stroke Gait Assessments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Collaborators
- Dr Titus Bihl, Hopital Cantonal Fribourgeois
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Oct 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.
Many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. In this project, the investigators will study post-stroke gaits of human patients and compare them to those of a control population during a goal-oriented task performed in different visual conditions.
The investigators want to test the hypothesis that during simple goal-oriented locomotor tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express navigational deficits.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-stroke patients | – | Behavioral: Kinematic measurementsPatients who experienced stroke and who already recover gait abilities. |
| Control population | – | Behavioral: Kinematic measurementsParticipants matching the criterion (age and gender) of the patients' group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The selected patients will be described by following parameters: * Parameters in relation to the person: age, gender. * Parameters in relation to the pathology: NIHSS, exact localisation, time since start of the symptoms, FIM (functional independence measure) visual field (ophthalmological examen), visual acuity (ophtalmological examen), visual neglect (Bells Cancellation Task), visuo-spatial short term working memory (Corsi span), visual motor integration (3-D cub subtest MoCA) * Parameters in relation to hospital stay: length of stay.
Key inclusion criteria (1 listed)
- Adult male and female subjects (18-->85 years old)
Key exclusion criteria (5 listed)
- Persons with history of an acquired or congenital neurological disorder, e.g. stroke, multiple sclerosis, Parkinson disease, increased intracranial pressure, etc.;
- Persons injured at the time of the experiments (fractures,…);
- Persons having reported repetitive spatial troubles/disorders;
- Persons with eye disorders and non-corrected vision problems;
- Pregnant women.
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 |
|---|---|---|
| Kinematic measurements | Behavioural | Control population, Post-stroke patients |
Primary outcome
Walking stability indices of post-stroke patients
Time frame: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
Spatial accuracy of walking trajectories in post-stroke patients
Time frame: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
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 25 Oct 2017.
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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 Post-stroke Gait Assessments, run by University of Fribourg 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 5 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 25 Oct 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?
Walking stability indices of post-stroke patients (time frame: 1 hour and 30 minutes (including pre-tests, instructions delivery...).). The study lists 2 primary outcomes in all. 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 25 Oct 2017.