Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Reactive Balance Training in Augmented Reality for Older Adults

1 de outubro de 2026 atualizado por: The Hong Kong Polytechnic University

The Combined Effects of Reactive Balance Training in an Augmented Reality Environment on Postural Stability in Community-dwelling Older Adults With an Increased Risk of Falling: A Randomized Controlled Trial

This is a single-blinded study. The participants will be equally randomized to either the reactive balance training with augmented reality (RBT+AR) group or the control (treadmill walking) group. Changes in postural stability, functional mobility/strength, balance performance, quality of life, balance confidence, muscle activation, and executive function following RBT+AR compared to treadmill walking only will be investigated.

Visão geral do estudo

Descrição detalhada

This randomized controlled trial will recruit thirty-six community-dwelling older adults with increased fall risk. The participants will be equally randomized to either the RBT+AR group or the control group. The RBT+AR group will receive two sessions of treadmill-based RBT with 224 forward and backward perturbations, simulating tripping and slipping, while walking with AR headsets, and the control group will receive two sessions of treadmill walking without perturbation and AR. Between-group differences in behavior will be examined before and after training to identify training-induced changes in postural stability. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.

Tipo de estudo

Intervencional

Inscrição (Estimado)

36

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

60 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Community-dwelling adults aged 60 years old or older
  • Able to communicate effectively in Cantonese or Mandarin
  • Able to walk independently on level ground for at least 30 minutes
  • Abbreviated Mental Test (Hong Kong version) scores > 6
  • Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing.

Exclusion Criteria:

  • Uncorrected vision or hearing impairment
  • Osteoporosis
  • Have a history of hip or knee replacement
  • Resting blood pressure ≥ 160/100 mmHg
  • Resting heart rate exceeds the 60-100 beat/min normal range
  • Have musculoskeletal conditions causing pain or functional limitation that would preclude safe performance of study procedures (e.g., acute fracture)
  • Have cardiovascular conditions that may pose risks during training or assessment (e.g., uncontrolled arrhythmias)
  • Have mental health conditions impairing decision-making capacity or ability to comply with study instructions (e.g., psychosis)
  • Have neurological conditions affecting balance, coordination in a way that would increase safety risk (e.g., Parkinson's disease)
  • Participating or planning to participate in another fall prevention program.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Reactive balance training with augmented reality group

The group will receive two sessions of treadmill-based reactive balance training with 240 forward and backward perturbations, simulating tripping and slipping, while walking with augmented reality headsets.

It will be two sessions of treadmill-based RBT with 240 forward and backward perturbations, simulating tripping and slipping, while walking with augmented reality headsets. Each session will last approximately one hour. Participants will be instructed to recover their balance and continue walking after each perturbation.

Comparador Ativo: Control group

The group will receive two sessions of treadmill walking without perturbation and augmented reality.

It will be a two sessions training with each session lasting for approximately an hour. The same training duration and format will be used as the experimental group, except that no perturbations and augmented reality will be induced during the treadmill walking.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Postural stability
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Postural stability at the recovery steps after the perturbation will be calculated as the distance between the absolute center of mass (CoM) position in an anteroposterior direction relative to the closest edge of the Base of Support (BoS) normalized by foot length. The absolute CoM position and BoS position will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.

Pre-intervention, 1 week after intervention and 4 months after intervention.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of real-life falls
Prazo: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.

The number of real-life falls in months after randomization will be recorded. Fall circumstances and related injuries will be required via phone contact. A fall is defined as an event resulting in a person unintentionally coming to rest on the ground or other lower level, not as the result of a major intrinsic event (e.g., syncope, stroke, or overwhelming hazard such as an earthquake).

1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
Generic balance ability
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Generic balance ability will be assessed by the Brief-BESTest. Brief-BESTest can challenge balance across anticipatory postural adjustments, postural responses, sensory orientation and stability in gait, allowing for comprehensive examination of improvements that occur in reactive control. As a shortened version of the BESTest, the Brief-BESTest is an 8-item balance assessment containing 1 item for each of the 6 subsections of the BESTest.

Pre-intervention, 1 week after intervention and 4 months after intervention.
Mobility
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention

Mobility will be assessed by Timed Up and Go test and Dual-Task Timed Up and Go test (in the unit of seconds)

Pre-intervention, 1 week after intervention and 4 months after intervention
Dynamic balance
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Dynamic balance will be assessed by Alternative Step Test (in the unit of seconds).

Pre-intervention, 1 week after intervention and 4 months after intervention.
Balance confidence
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Balance confidence will be measured with the Chinese version of the shortened version of Activities-specific Balance Confidence Scale (ABC-6). The scale value is from 0 to 100, with higher values representing higher balance confidence.

Pre-intervention, 1 week after intervention and 4 months after intervention.
Functional lower body strength
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Functional lower body strength will be assessed by Five-time Sit to Stand Test (in the unit of seconds).

Pre-intervention, 1 week after intervention and 4 months after intervention.
Cognitive flexibility and executive function
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Cognitive flexibility and executive function will be assessed by Trial Making Tests A and B (in the unit of seconds).

Pre-intervention, 1 week after intervention and 4 months after intervention.
Cognitive impairment
Prazo: Pre-intervention.

Cognitive impairment will be assessed by Abbreviated Mental Test (AMT). AMT is a 10-item test, with a 10-point scale. A score less than 6 suggests a significant cognitive deficit.

Pre-intervention.
Depressive symptoms
Prazo: Pre-intervention.

Depressive symptoms will be assessed by Five-Item Geriatric Depression Scale. Participants will be asked to answer 5 questions as yes or no. The answer "no" for the first question and "yes" for the other four questions will be evaluated for depression.

Pre-intervention.
Personality traits
Prazo: Pre-intervention.

Personality traits assessed by Ten-Item Personality Inventory. It has 10 items, each item adopts a 5-level score of 1 (Disagree strongly) to 5 (Agree strongly), and a higher dimension score indicates a stronger individual's personality proneness.

Pre-intervention.
Generic preference-based quality-of-life
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Generic preference-based quality-of-life will be assessed by five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

In the EQ-5D descriptive system, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each health state is identified by a five-digit code, with 11111 representing the best and 55555 the worst possible health state.

In the EQ CAS, the scale value is from 0 to 100, with higher values representing higher balance confidence.

Pre-intervention, 1 week after intervention and 4 months after intervention.
Muscle activations
Prazo: Pre-intervention, 1 week after intervention and 4 months after intervention.

Muscle activations will be assessed by surface electromyography using an electromyography system (Trigno IM, Delsys Inc., Natick, MA, USA). Fourteen electrodes are placed bilaterally over erector spinae, rectus abdominis, gastrocnemius medialis, biceps femoris, rectus femoris, tibialis anterior, and gluteus medius according to the SENIAM guidelines (www.seniam.org) by the physical therapist.

Pre-intervention, 1 week after intervention and 4 months after intervention.
Physical activity
Prazo: Pre-intervention, and 4 months after intervention.

Physical activity will be assessed by the Physical Activity Scale for the Elderly. This questionnaire will ask participants to recall their activity over the last 7-days. Activity types include sitting, walking, sport/recreation, exercise, occupational and household. A total score for physical activity can be calculated using these answers and the predetermined weights associated with each activity.

Pre-intervention, and 4 months after intervention.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de julho de 2026

Conclusão Primária (Estimado)

31 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de outubro de 2026

Primeira postagem (Real)

6 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de outubro de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HSEARS20260423001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever