NCT02263560

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

October 6, 2014

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Walking stability indices of post-stroke patients

    1 hour and 30 minutes (including pre-tests, instructions delivery...).

  • Spatial accuracy of walking trajectories in post-stroke patients

    1 hour and 30 minutes (including pre-tests, instructions delivery...).

Study Arms (2)

Post-stroke patients

Patients who experienced stroke and who already recover gait abilities.

Behavioral: Kinematic measurements

Control population

Participants matching the criterion (age and gender) of the patients' group.

Behavioral: Kinematic measurements

Interventions

Control populationPost-stroke patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Adult male and female subjects (18--\>85 years old)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University (UNIFR) and Hospital of Fribourg (HFR)

Fribourg, 1700, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (PhD)

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 13, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations