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

12 settembre 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Hong Kong
    • Hung Hom
      • Kowloon, Hung Hom, Hong Kong
        • Reclutamento
        • School of Optometry, The Hong Kong Polytechnic University
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Ming-Yan Allen Cheong, PhD

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

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

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control waitlist
Participants will wait for 3 months before receiving intervention
Sperimentale: 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.
Altro: 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.
Sperimentale: 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).
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
General-health related quality of life
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual function
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
fall incidence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Hong Kong Polytechnic University

Collaboratori

Wu Jieh Yee Charitable Foundation

Investigatori

  • Investigatore principale: Ming-Yan Allen Cheong, PhD, the Hong Kong Polytechnic University

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 (Stimato)

29 settembre 2026

Completamento primario (Stimato)

30 agosto 2029

Completamento dello studio (Stimato)

30 settembre 2029

Date di iscrizione allo studio

Primo inviato

12 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2026

Primo Inserito (Effettivo)

18 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P0056196

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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