- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07781995
AI-Adaptive AR Training for Balance and Falls Prevention in Older Adults
Artificial Intelligence-Enhanced Augmented Reality Training to Improve Mobility, Balance, and Prevent Falls in Older Adults: A Feasibility Study
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Falls are a significant health concern among older adults and can contribute to injury, fear of falling, reduced physical activity, functional decline, and loss of independence. Exercise-based interventions that target balance, gait, strength, and functional mobility can reduce fall risk in older adults. However, implementation outside supervised clinical settings may be limited by insufficient training dose, lack of individualized progression, and difficulty maintaining engagement.
Augmented reality (AR) provides an opportunity to deliver balance and mobility training while allowing participants to interact with virtual training elements within their physical environment. Previous studies have investigated AR-assisted exercise and rehabilitation approaches in older adults, including balance, gait, and mobility training. Although these approaches have demonstrated potential benefits, further research is needed to determine how AR-based training can be individualized and implemented effectively in community-dwelling older adults. Incorporating machine learning-based adaptation may enable training difficulty to be adjusted according to individual performance and provide an appropriate and progressive level of challenge.
This study will evaluate the feasibility and preliminary effects of an artificial intelligence (AI)-enhanced AR balance and mobility training program in community-dwelling older adults aged 55-80 years. The study will use a single-arm, open-label, repeated-measures design. Participants will complete a baseline assessment (T1), followed by an 8-week AR training intervention and an immediate post-intervention assessment (T2).
The intervention will consist of 3-5 training sessions per week for 8 weeks, with each session lasting approximately 30 minutes. Participants will perform standing- and walking-based activities presented through wearable AR smart glasses. Training activities will include obstacle negotiation, path following, step targeting, turning, and directional-change tasks designed to challenge functional balance and mobility. Training sessions may be completed at McMaster University or, for eligible participants, in the participant's home. Before beginning home-based training, the home environment will be assessed for suitability, and the participant will complete an initial on-site training session under direct supervision.
The AR training application was developed by the McMaster University research team and runs on a dedicated smartphone connected to the AR glasses. The application incorporates a machine learning model that adapts task difficulty according to individual participant performance using a challenge-point framework designed to maintain an approximately 80% task success rate. When performance exceeds this target, the system iteratively increases task difficulty, for example by increasing target speed or decreasing target size. When performance falls below the target, the system reduces task difficulty, for example by decreasing target speed or increasing target size. The model uses positional and movement data collected through the AR glasses together with training performance metrics, including target success rate, accuracy, response time, and movement speed, to evaluate participant performance and inform adjustments to training difficulty.
The primary objective is to evaluate the feasibility of the intervention based on participant retention, adherence to the prescribed training program, and weekly session completion. Secondary outcomes will characterize preliminary within-participant changes in balance, functional mobility, and balance confidence from baseline to immediately following the intervention. Assessments will include the Mini Balance Evaluation Systems Test (Mini-BESTest), Timed Up and Go (TUG), Activities-specific Balance Confidence (ABC) Scale, BTrack force plate assessments, and instrumented movement assessments using inertial measurement units (IMUs).
Findings from this feasibility study will inform the implementation and design of future studies evaluating individualized AR-based balance and mobility training in older adults.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Aimee Nelson
- Numer telefonu: 28053 (905) 525-9140
- E-mail: nelsonaj@mcmaster.ca
Kopia zapasowa kontaktu do badania
- Nazwa: Xiru Wang
- E-mail: wangx256@mcmaster.ca
Lokalizacje studiów
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8S 4L8
- Ivor Wynne Center
-
Kontakt:
- Aimee Nelson
- Numer telefonu: 28053 9055259140
- E-mail: nelsonaj@mcmaster.ca
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Aged 55 - 80 years
- Able to ambulate independently with or without an assistive device
- Able to understand and follow instructions unimpeded by significant cognitive barriers (MoCA score must be 24/30 or higher)
- Self-reported balance concerns or perceived risk of falls (e.g., reduced balance confidence)
- Must be able to provide a list of current medications to the experimenters and the changes in medications during the study
- Vision that normal or near normal with/without the use of glasses/lenses
- Able to understand and follow study instructions in English
Exclusion Criteria:
- Engaging in any additional balance or mobility training programs while participating in the study
- Diagnosed neurological conditions that substantially impair balance or mobility (e.g., stroke, Parkinson's disease, Traumatic Brain Injury)
- Medical conditions that contraindicate moderate physical activity
- Vision impairment that cannot be corrected by glasses or lenses
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Participants receive the 8-week AI-enhanced AR balance and mobility training, 3-5 sessions per week.
Participants will complete an 8-week AI-enhanced augmented reality balance and mobility training program, with 3-5 sessions per week lasting approximately 30 minutes each.
Training includes standing- and walking-based tasks such as obstacle negotiation, path following, step targeting, turning, and directional changes.
Task difficulty is adaptively adjusted based on participant performance using a machine learning model designed to maintain an approximately 80% task success rate.
|
Participants will complete an 8-week AI-enhanced augmented reality (AR) balance and mobility training program, consisting of 3-5 sessions per week of approximately 30 minutes each.
Using AR smart glasses connected to a dedicated smartphone, participants will perform standing- and walking-based tasks, including obstacle negotiation, path following, step targeting, turning, and directional changes.
A machine learning model adapts task difficulty based on individual performance using a challenge-point framework targeting approximately 80% task success.
Difficulty is iteratively increased or decreased based on performance, including adjustments to target speed and target size.
Training may be completed at McMaster University or, following an initial supervised session and home safety assessment, at the participant's home.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Participant Retention Rate
Ramy czasowe: From baseline (T1) through post-intervention assessment (T2), approximately 8 weeks
|
Retention will be calculated as the percentage of enrolled participants who complete the post-intervention assessment (T2): number completing T2 divided by the number enrolled at baseline (T1), multiplied by 100.
|
From baseline (T1) through post-intervention assessment (T2), approximately 8 weeks
|
|
Adherence to the Augmented Reality Training Program
Ramy czasowe: Throughout the 8-week intervention
|
Adherence will be calculated for each participant as the percentage of prescribed AR training sessions completed during the 8-week intervention.
Participants are prescribed 3-5 sessions per week, with each session lasting approximately 30 minutes.
|
Throughout the 8-week intervention
|
|
Weekly Augmented Reality Training Session Completion
Ramy czasowe: Weekly throughout the 8-week intervention
|
Weekly training participation will be assessed based on the number of AR training sessions completed each week.
Completion of 3-5 sessions per week will be used to characterize adherence to the intended training frequency.
|
Weekly throughout the 8-week intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Timed Up and Go (TUG) Performance
Ramy czasowe: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
Functional mobility will be assessed using the Timed Up and Go test.
Participants stand from a seated position, walk 3 metres, turn, return, and sit down.
Performance is measured in seconds, with shorter completion times indicating better functional mobility.
|
Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
|
Change in BTrackS Limits of Stability
Ramy czasowe: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
Limits of Stability will assess the participant's ability to voluntarily control center of pressure within the base of support.
Participants move a cursor representing center of pressure across a computer display while standing on the BTrackS force plate.
Performance is quantified by the area covered in square centimetres (cm²).
|
Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
|
Change in BTrackS Fall Risk Assessment
Ramy czasowe: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
Postural stability during quiet standing will be assessed using the BTrackS Fall Risk Assessment.
Center-of-pressure path length is measured while participants stand with eyes closed and hands on their hips.
The outcome is expressed as total center-of-pressure path length in centimetres.
|
Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
|
Change in BTrackS Weight Distribution
Ramy czasowe: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
The BTrackS Weight Distribution Test will assess left-right and front-back weight-bearing symmetry and center-of-pressure alignment while participants stand with their feet shoulder-width apart.
|
Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
|
Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Score
Ramy czasowe: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
The Mini-BESTest assesses dynamic balance across anticipatory postural control, reactive postural responses, sensory orientation, and gait stability.
Total scores range from 0 to 28, with higher scores indicating better balance performance.
|
Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
|
Change in Activities-specific Balance Confidence (ABC) Scale Score
Ramy czasowe: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
The Activities-specific Balance Confidence (ABC) Scale will assess perceived confidence in maintaining balance during everyday activities.
Scores are expressed as a percentage, with higher scores indicating greater balance confidence.
|
Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
|
Change in Inertial Measurement Unit (IMU)-derived Gait and Turning Measures
Ramy czasowe: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
Wearable inertial measurement units (IMUs) equipped with accelerometers and gyroscopes will be used during standardized walking and turning tasks to quantify spatiotemporal gait and turning characteristics, including gait timing, variability, and movement stability.
|
Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
- Chen W, Li M, Li H, Lin Y and Feng Z (2023) Tai Chi for fall prevention and balance improvement in older adults: a systematic review and meta-analysis of randomized controlled trials. Front.
- Pillay, J., Gaudet, L.A., Saba, S. et al. Falls prevention interventions for community-dwelling older adults: systematic review and meta-analysis of benefits, harms, and patient values and preferences.
- Yoo HN, Chung E, Lee BH. The Effects of Augmented Reality-based Otago Exercise on Balance, Gait, and Falls Efficacy of Elderly Women. J Phys Ther Sci.
- Chen PJ, Penn IW, Wei SH, Chuang LR, Sung WH. Augmented reality-assisted training with selected Tai-Chi movements improves balance control and increases lower limb muscle strength in older adults: A prospective randomized trial. J Exerc Sci Fit.
- Im DJ, Ku J, Kim YJ, Cho S, Cho YK, Lim T, Lee HS, Kim HJ, Kang YJ. Utility of a Three-Dimensional Interactive Augmented Reality Program for Balance and Mobility Rehabilitation in the Elderly: A Feasibility Study. Ann Rehabil Med.
- Vieira ER, Civitella F, Carreno J, Junior MG, Amorim CF, D'Souza N, Ozer E, Ortega F, Estrázulas JA. Using Augmented Reality with Older Adults in the Community to Select Design Features for an Age-Friendly Park: A Pilot Study. J Aging Res.
- Blomqvist S, Seipel S, Engström M. Using augmented reality technology for balance training in the older adults: a feasibility pilot study. BMC Geriatr.
- Lamichhane P, Sukralia S, Alam B, Shaikh S, Farrukh S, Ali S, Ojha R. Augmented reality-based training versus standard training in improvement of balance, mobility and fall risk: a systematic review and meta-analysis. Ann Med Surg (Lond).
- Vinolo Gil MJ, Gonzalez-Medina G, Lucena-Anton D, Perez-Cabezas V, Ruiz-Molinero MDC, Martín-Valero R. Augmented Reality in Physical Therapy: Systematic Review and Meta-analysis. JMIR Serious Games.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 20142
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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 .