- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02310880
Efficacy of Enhancing Low Vision Mobility Thru Visual Training in Virtual World
25 maggio 2015 aggiornato da: University of Alabama at Birmingham
Low vision patients have difficulty acquiring sufficient visual information in a timely manner for the purpose of performing challenging daily tasks, such as traveling independently and safely through busy streets.
The advance of virtual reality techniques has provided a potential platform for training low vision patients to use their remaining vision more efficiently, but the key issue is always whether the patient's visual experiences in a virtual world can be transferred to the real world.
The proposed study is designed to provide definite answer to this question.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
NEI's National Plan for Eye and Vision Research has identified Low Vision and Blindness Rehabilitation as one of the most pressing needs and opportunities in vision research.
Since most low vision (LV) patients nowadays have useable vision, an important aspect of LV rehabilitation is to maximize the use of the patient's remaining vision.
Visual skills are especially important in tasks such as traveling independently through busy streets, in which distant, rapidly changing events have direct impact on the patient's task efficiency and safety.
The patient has to learn new information acquisition skills to compensate for their impaired vision.
Current LV training for such skills is done on real streets in a one-on-one, trainer/trainee sessions.
This way of training, however, usually does not expose clients to all the circumstances that they need to deal with, usually does not provide graded levels of task difficulty and repeatable conditions that facilitate learning, and cannot meet the needs of the majority of LV patients because of the shortage and the high cost of LV trainers.
The advances of virtual reality (VR) technology have made it possible and affordable to realistically simulate complex and dynamic visual and auditory environments to facilitate LV rehabilitation.
However, the most important first step in applying VR technologies to LV rehabilitation is to determine whether the visual experiences of a LV person can be transferred to the real world.
Only when a positive transfer of visual skills is confirmed, can subsequent development of comprehensive VR training systems for all aspects of LV rehabilitation become worthwhile.
The purpose of this study is to accomplish this first step.
A set of visual skills for a most visually challenging task, crossing a signal-controlled street, is selected from standard orientation and mobility curriculum to study virtual experience transfer.
Existing technology are used to build a desktop computer-based VR simulator that can generate virtual street intersection scenarios that contain visual and auditory information required for practicing the skills to be studied.
Computer generated street intersections with pedestrians, traffic and control signals are projected to a large screen for the participant to view, like a movie.
Twenty LV persons are recruited from a university LV rehabilitation facility.
They are randomly assigned to practicing the selected visual skills at real or virtual street intersections.
Their skill levels are evaluated at real intersections before and immediately after their scheduled training.
The primary outcome of interest is the mean change of visual skills between pre- and post-training evaluations in the two groups.
The training is not a rehabilitation intervention because only the changes in visual/audio information gathering skills are trained and observed.
The participants are trained and evaluated on the sidewalks of the real and virtual street.
They are never allowed to step down the curb to avoid exposure to any danger.
The long-term goal is to develop interactive VR training systems that have multiple sensory and motor input and output modules and that incorporate the collective experiences of the LV rehabilitation profession.
Adding such systems to LV curriculum can greatly improve the affordability, accessibility, efficiency and the scope of LV rehabilitation.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
35
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35294
- The Clinical Eye Research Facility
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 19 anni a 81 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Low vision participants will be recruited from the patient populations of the Clinics of UAB School of Optometry and UAB Center for Low Vision Rehabilitation
Descrizione
Inclusion Criteria:
- Ambulatory and have independent traveling as one of their rehabilitation goals.
- Participants with central field loss should have best corrected binocular visual acuity between 20/200 and 20/1000, but with relatively intact peripheral visual field (>80o).
- Participants with peripheral visual field loss should have >20/63 visual acuity and no more than 20 deg diameter but not less than 8 deg diameter visual field in the better eye.
Exclusion Criteria:
- Participants who have a mixture of central and peripheral field loss.
- Previous or current recipient of O&M training.
- Participants who have plans to receive O&M training during the study period.
- Age younger than 19 or older than 81.
- Significant cognitive impairment as determined with the Short Portable Mental Status Questionnaire (≥2 errors); inability to understand and speak English.
- Severe hearing impairment that interferes with interactions with O&M specialists.
- Inability or unwillingness to make visits required by the study.
- Not living in the Birmingham-Jefferson county area.
- Persons who have a history of epilepsy or who are prone to motion sickness or simulator aftereffect, determined by an epileptic seizure history inquiry and a Motion Sickness History Questionnaire.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Low vision (virtual street training)
Low vision subjects trained in virtual streets and observed in real streets
|
|
Low vision (real street training)
Low vision subjects trained in real streets and observed in real streets
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The percentage of dangerous street crossing decisions and the street crossing decision safety scores
Lasso di tempo: 3-5 1-hour visits
|
The percentage of dangerous street crossing decisions is determined at real street corners during pre- and post-training evaluation sessions.
The subject is asked to say "GO" when she feels it is the safest time to cross the street.
A crossing decision is scored as dangerous if it is initiated in the red traffic light cycle or if there is < 25% of the "WALK" cycle left.
The percentage is the total number of dangerous decisions divided by the total number of crossing decisions made during one evaluation session.
The safety of a crossing decision is further quantified by recording the decision timing using a stopwatch and by converting the recorded time to a safety score.
The safety score is a continuous scale between 0 and 1.0.
The larger the safety score, the safer is the crossing decision.
A statistically significant reduction in the percentage dangerous crossing decisions and an increase in the safety scores after training is an indication of successful skill learning and transfer.
|
3-5 1-hour visits
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2010
Completamento primario (Effettivo)
1 marzo 2015
Completamento dello studio (Effettivo)
1 marzo 2015
Date di iscrizione allo studio
Primo inviato
3 dicembre 2014
Primo inviato che soddisfa i criteri di controllo qualità
4 dicembre 2014
Primo Inserito (Stima)
8 dicembre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 maggio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 maggio 2015
Ultimo verificato
1 dicembre 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- X100716003
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .