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Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired Adults

12 września 2026 zaktualizowane przez: Allen MY Cheong, The Hong Kong Polytechnic University

Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving Function and Quality of Life of Visually Impaired Patients: a Randomized Controlled Trial

This trial compares multidisciplinary vision rehabilitation and vision rehabilitation services to determine which service works better at improving overall quality of life for adults with visual impairment. Before receiving the intervention, participants will complete baseline measurements, including an eye examination, cognitive and hearing screenings, mobility and balance assessments, questionnaires on basic demographics and health, and a home environment assessment. This randomised controlled trial includes three arms: 1) control-waitlist (wait for 3 months before joining either intervention arm), 2) vision rehabilitation with low vision training only, and 3) multidisciplinary vision rehabilitation arm.

The intervention period lasts for eight weeks, comprising of four on-site training sessions.

  • During the intervention period, all participants will receive low-vision training on the use of advanced assistive technology.
  • Those in the multidisciplinary group will also receive counselling, exercise training, and home assessment with home modifications (if needed).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1000

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Hongkong
    • Hung Hom
      • Kowloon, Hung Hom, Hongkong
        • Rekrutacyjny
        • School of Optometry, The Hong Kong Polytechnic University
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Ming-Yan Allen Cheong, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Aged 18 and 80 years
  • Community-dwelling in Hong Kong
  • Cantonese Speaker
  • Clinical diagnosis of low vision (best-corrected visual acuity <6/18; and/or field loss of < 20 degree)
  • Stable ocular condition for ≥ 3 months
  • Owns a smartphone
  • Not currently participating in any vision rehabilitation programme
  • Willing to participate and commit for at least 6 months to 12 months
  • Provides informed consent

Exclusion Criteria:

  • Living in a nursing home/ institutionalized
  • Self-reported severe cognitive impairment or HK-MoCA-VI cut off score of 12
  • Self-reported severe hearing impairment
  • Uncontrolled systemic ocular diseases/ neurological or psychiatric conditions
  • Immobility caused by physical impairment
  • Refuse to provide written informed consent
  • Participating in another vision rehabilitation programme during the trial period

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Control waitlist
Participants will wait for 3 months before receiving intervention
Eksperymentalny: Vision rehabilitation arm
Participants assigned to the Vision rehabilitation arm will only receive the low vision training on the use of advanced assistive technology. Group-based training will be provided.
Inny: Vision rehabilitation incorporating low vision training only
This intervention includes providing vision rehabilitation that incorporates advanced assistive technology to support daily living. The intervention lasts for eight weeks, which includes four on-site training sessions (1 hour each). The group-based training includes an introduction to operating smart glasses and AI assistant applications on mobile devices, and offers scenario-based training on utilising these advanced assistive technologies to perform daily activities.
Eksperymentalny: Multidisciplinary vision rehabilitation
Multidisciplinary vision rehabilitation includes group-based low-vision training, group-based solution-focused therapy, group-based exercise training, and home assessment with home modification (if needed).
Inny: Multidisciplinary vision rehabilitaion
A holistic approach to provide vision rehabilitation services, including low vision training incorporating advanced assistive technology, home-based exercise training, counselling and home assessment with home modification. The intervention lasts for eight weeks. On-site, group-based training sessions are provided for low vision training (1 hour), exercise training (1 hour), and solution-focused therapy (1.5 hours). Low vision training components are identical to the components received in the vision rehabilitation (low vision component) arm. Exercise training focuses on strengthening lower-limb muscles designed to reduce risk of falls. Solution-focused therapy focuses on helping participants build solutions to visual impairment problems and facilitate their development of preferred futures. Participants will receive minor home modifications, if needed, after the home assessment.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
General-health related quality of life
Ramy czasowe: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
General health related quality of life will be measured using the Hong Kong version of the EuroQoL 5-Dimension instrument 5-level (EQ-5D-5L-HK). Five aspects will be meausred including mobility, self-care, usual activities, pain/discomport, anxiety/depression. A scale of 1 to 5 will be rated. The participant will also be asked to give an overall score for their health at the time of measurement, which is out of 100, 0 means poorest
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Vision-related quality of life
Ramy czasowe: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Vision-related quality of life will be measured by the Low Vision Visual Functioning Questionnaire 48 (LV VFQ-48). The LV VFQ48 was translated into Traditional Chinese. LV VFQ-48 measures the difficulties in performing daily activities.
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Visual function
Ramy czasowe: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Visual function will be measured using the Melbourne Low-Vision ADL Index (MLVAI). It includes 17 functional performance measures and 9 self-reported questions related to real-world daily activities. The original 17-item functional tasks in MLVAI were modified to align with the local context. Item descriptions were translated into Traditional Chinese. The scoring system has been revised to include quantifiable completion time to improve the reliability of performance scoring between assessors. Baseline assessment will collect two types of data: the original performance using habitual glasses and the performance score using a mobile phone (with any assistive functions enabled). The post-intervention assessment will collect performance scores using the advanced assistive technology prescribed to the participants during the intervention (i.e., smart glasses and/or an AI assistant on their mobile phone).
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Level of hope (psychological wellbeing)
Ramy czasowe: Changes from baseline and within one month after the completion of an eight-week intervention.
The level of hope is measured by the Herth Hope Index (HHI). This index includes 12 self-reported items, covering three subscales "Sense of temporality and future", "Positive readiness and expectancy", and "Interconnectedness with self and others". Each item is rated on a 4-point Likert scale, where 1 indicates strongly disagree, and 4 indicates strongly agree. The total score can range from 12 to 48. The higher the score, the greater the level of hope.
Changes from baseline and within one month after the completion of an eight-week intervention.
Depression severity (psychological wellbeing)
Ramy czasowe: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Depression severity is measured using the Patient Health Questionnaire (PHQ-9) . The PHQ-9 comprises nine questions, along with an impact question measuring the extent to which depressive symptoms affect daily functioning. Depression severity is measured over a two-week period. The frequency of the symptoms is rated on a four-point scale, where 0 = "Not at all", 1 = "several days", 2 = "More than half of the days", and 3 = "Nearly every day". The total score can range from 0 to 27. A higher PHQ-9 score indicates higher depressive severity. A cutoff score of 20 or above indicates severe depression.
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Anxiety severity (Psychological wellbeing)
Ramy czasowe: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Severity of anxiety is assessed using the Generalised Anxiety Disorder-7 (GAD-7). GAD-7 includes seven questions along with one impact question. On a four-level scale, GAD-7 captures the frequency of anxiety symptoms experienced over the past two-week period. Each question is rated on a four-point scale, where 0 = "Not at all", 1 = "Several days", 2 = "More than half the days", 3 = "Nearly every day". The total score can range from 0 to 21. The higher the GAD-7 score, the higher the level of anxiety. A cutoff score of 15 or above indicates a severe level of anxiety.
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Balance and mobility functions
Ramy czasowe: Changes in measurement from Baseline to within one month after the completion of an eight-week intervention programme.
Balance and mobility function will be measured using the Mini Balance Evaluation System Test (miniBesTest). This is a 14-item assessment. Each item is scored on a three-point ordinal scale, with 0 indicating severe impairment in performance, 1 indicating moderate impairment in performance, and 2 indicating normal performance. The 14 items cover anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The highest possible score is 28, with a score of 21 or below indicating an elevated risk of falls. The performance of the miniBesTest is video-recorded.
Changes in measurement from Baseline to within one month after the completion of an eight-week intervention programme.
Mobility
Ramy czasowe: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
The mobility function is assessed using the Narrow Path Walking Test (NPWT). The performance is scored based on the completion time (in seconds) taken to complete a six-metre-long path. A green mat measuring 40 x 300cm is used to divide a path into two 20-centimetre-wide pathways. The participants will be asked to stand up from a chair, walk around the green mat while avoiding stepping over the boundaries, and return to the chair at the starting point. Step errors are marked as those that step outside the boundaries. Three trials are allowed, and the average completion time will be used as final performance. The performance is video-recorded.
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Lower body functioning
Ramy czasowe: Changes in measurement from Baseline to within one month after completion of an eight-week intervention
This will be assessed by the 30-second Chair Stand Test. The participant will be asked to sit fully on a chair and rise to a full standing position as many times as possible within 30 seconds. During the assessment, they are not allowed to use their hands for assistance. The assessor will count the number of repetitions a participant can complete within 30 seconds. Anyone who uses their hands to stand up will be scored a "0".
Changes in measurement from Baseline to within one month after completion of an eight-week intervention
Fear of fall
Ramy czasowe: Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
Fear of fall is assessed using the Chinese-validated version of the 16-item Fall Efficacy Scale International (FES-I). Each item is rated on a four-point Likert scale, where 1 indicates not concerned and 4 indicates extremely concerned. The total score can range from 16 to 84. The higher the FES-I score, the higher the fear of falls. A cutoff score of 28 or higher indicates a higher risk of falls.
Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
Awareness of fall protective behaviour
Ramy czasowe: Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
This is assessed by the 30-item Fall Behavioural Scale (FaB). Each item is rated on a four-level Likert scale, with 1 = "never", 2 = "sometimes", 3 = "often", 4 = "always", and an option of "not applicable". The higher the FaB score, the higher the use of protective behaviours.
Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
Environmental fall hazards (home environement)
Ramy czasowe: Changes in measurement from baseline to within one month after the completion of an eight-week intervention
Fall hazard in home environment is assessed by the WestMead Home Safety Assessment (WeHSA). The WeHSA assessed a total of 72-item hazard categories across 13 areas at home, where applicable. The outcome measure is the number of hazards identified across these 13 areas.
Changes in measurement from baseline to within one month after the completion of an eight-week intervention

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
fall incidence
Ramy czasowe: This outcome will be collected at baseline, within one month after completion of intervention, 3-month post intervention, 6-month post intervention, 9-month post intervention and 12-month post intervention.
The number of falls in the past 12 months, fall characteristics and consquences will be collected
This outcome will be collected at baseline, within one month after completion of intervention, 3-month post intervention, 6-month post intervention, 9-month post intervention and 12-month post intervention.
advanced assistive technology adoption rate
Ramy czasowe: The measurement will be taken at baseline.
The adoption rate is the proportion of people who are introduced to an advanced assistive device and agree to use the device during the intervention period. A binary outcome will be collected, i.e. yes/ no.
The measurement will be taken at baseline.
advanced assistive technology continuation rate
Ramy czasowe: Outcome measurement collected at 3 months post intervention, 6 month post intervention, and 12 month post intervention.
The continuation rate of the intervention components will be recorded as a binary outcome, i.e. yes or no. We collect whether the participant continue to engage in execise training, use of AI glassess/ smartphone accessibility, after intervention period.
Outcome measurement collected at 3 months post intervention, 6 month post intervention, and 12 month post intervention.
User satisfaction of assistive tehcnology
Ramy czasowe: The outcome will be collected in the 4th week of the intervention period and within one month after the completion of the eight-week intervention.
This will be assessed using the Chinese version of the Quebec User Evaluation of Satisfaction with Assistive Technology (C-QUEST). This survey has 12 statements focusing on the device domain (Dimension, weight, adjustment, safety, durability, simplicity of use, comfort, and effectiveness) and the service domain (delivery service, repair/servicing, professional service, and follow-up service). Each statement is rated on a scale from 1 to 5, with 1 = "not satisfied at all" to 5 = "very satisfied". The questionnaire will yield three scores: the sub-scores for the device and service domains, and the total C-QUEST score. The CQUEST score can range from 12 to 60. The higher the CQUEST score, the higher the satisfaction towards the prescribed assistive technology. Each participant is also required to identify the three most important items out of the 12 items.
The outcome will be collected in the 4th week of the intervention period and within one month after the completion of the eight-week intervention.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Hong Kong Polytechnic University

Współpracownicy

Wu Jieh Yee Charitable Foundation

Śledczy

  • Główny śledczy: Ming-Yan Allen Cheong, PhD, The Hong Kong Polytechnic University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

29 września 2026

Zakończenie podstawowe (Szacowany)

30 sierpnia 2029

Ukończenie studiów (Szacowany)

30 września 2029

Daty rejestracji na studia

Pierwszy przesłany

12 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 września 2026

Pierwszy wysłany (Rzeczywisty)

18 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • P0056196

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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