- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07809243
Virtual Reality-based Perceptual Learning Therapy for Visually Impaired Population
Virtual Reality-based Perceptual Learning Therapy for Visually Impaired Population: Study Protocol for a Randomized Clinical Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ke Zhang
- Telefonnummer: 852+53748502
- E-post: ke.zhang@cevr.hk
Studiesteder
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Hong Kong, Hong Kong
- Units 901-903, 9/F, Building 17W, 17 Science Park West Avenue, Hong Kong Science Park, Pak Shek Kok, Shatin
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Ta kontakt med:
- Ke Zhang
- Telefonnummer: 852+53748502
- E-post: ke.zhang@cevr.hk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Humphrey visual field analyzer (HFA) visual field loss (mean deviation of ≤-6 dB)
Exclusion Criteria:
- Comprehension disorder that does not allow understanding of tests or training (e.g., in severe aphasia)
- Currently under other PL treatment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Virtual Reality-based Perceptual Learning Training
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Prior to the training session, participants' visual fields will be assessed using standard automated perimetry (e.g., Humphrey Field Analyzer, 30-2 or 24-2 grid). Based on the decibel (dB) sensitivity maps from the clinical results, each participant's visual field will be classified into three functional zones: the intact zone (normal sensitivity), the absolute blind zone (<0 dB), and the transition zone or "gray area" (1~20 dB; relative scotoma characterized by reduced but present sensitivity). One training session will be 20 ~30 minutes for each task. Participants will be asked to complete a total of 6 training sessions. In each training session, the participant will be asked to complete two tasks (i.e., ecological multiple object tracking task and dual task) which will take approximately one hour. Training sessions will be spaced at intervals of 1~7 days. |
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Ingen inngripen: No-intervention Control
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Area Improvement
Tidsramme: Within one week after the training ends
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Primary outcome is the visual area measured using the HVF (24-2, SITA-standard), where sensitivity increased by 6 dB or more relative to baseline in the defective hemifield or whole field.
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Within one week after the training ends
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pre/post-intervention assessments of visual search
Tidsramme: Within one week after the training ends
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Visual search: Perceptual processing efficiency will be assessed using a visual search task - spatial configuration search task (Wolfe et al., 2010).
In this task, participants were instructed to fixate on the centre of the screen and to locate a target.
Each trial began with a short tone, followed after 500 ms by a search display.
Participants pressed a key to report whether the target was present (in 50% of trials) or absent, responding as quickly and accurately as possible.
Feedback-indicating response correctness-appeared for 500 ms after each trial.
Trials were separated by a 1000-ms inter-trial interval.
Set size was systematically varied across two conditions-6 items (1 target + 5 distractors) and 18 items (1 target + 17 distractors)-to quantify search efficiency.
For each participant, reaction time (RT) was regressed on set size, and the resulting slope served as the primary index of perceptual processing efficiency: shallower slopes indicate higher efficiency.
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Within one week after the training ends
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Pre/post-intervention assessments of balance ability
Tidsramme: Within one week after the training ends
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Balance: The Bertec Balance Advantage™ system is used to assess participants' balance before and after training.
During the test, participants are asked to stand under different challenging conditions.
Balance-challenging conditions include (1) standing on a firm or foam surface (Fi/Fo); (2) standing surface with backward or forward translation (BT/FT); and (3) standing with their eyes close (EC).
Outcome measures, including root mean square sway of the center of pressure in the anterior - posterior and medial -lateral directions (mm/s), total sway path length (mm), and maximum CoP displacement in the AP and ML directions (mm)
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Within one week after the training ends
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Pre/post-intervention assessments of fear of fall
Tidsramme: Within one week after the training ends
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Fear of fall: The English & Chinese version of the Falls Efficacy Scale-International (FES-I) is a validated and reliable questionnaire used to assess fear of falling in everyday life.
The FES-I total score ranges from 16 to 64.
Higher scores indicate greater concern about falling and therefore a worse outcome.
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Within one week after the training ends
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Pre/post-intervention assessments of quality of life (a)
Tidsramme: Within one week after the training ends
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The National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25), English and Chinese versions.
The NEI VFQ-25 scores range from 0 to 100.
Higher scores indicate better visual functioning and better vision-related quality of life and therefore represent a better outcome.
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Within one week after the training ends
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Pre/post-intervention assessments of quality of life (b)
Tidsramme: Within one week after the training ends
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The Chinese version of the Low Vision Quality of Life Questionnaire (CLVQOL) is used to assess vision-related quality of life.
The CLVQOL contains 25 items, each scored from 0 to 5, resulting in a theoretical total score ranging from 0 to 125.
Higher scores indicate fewer vision-related difficulties and better vision-related quality of life and therefore represent a better outcome.
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Within one week after the training ends
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CEVR-PL-20260831
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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