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Dose-Response and Phase-Specific Effects of Graded Cognitive Load on Functional Mobility in Older Adults: A Kinematic Analysis (CL)

5 de setembro de 2026 atualizado por: Mostafa Abd-Elsamie Mohamed Abd-Elhamied seliem, Cairo University
This study will be conducted to investigate the effect of dose-response and phase-specific effects of Graded Cognitive Load affect on functional mobility in Older Adults

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

Aging is associated with progressive changes in both the central nervous system and the musculoskeletal system, leading to declines in motor performance, balance, and functional mobility. These changes include reduced cortical processing efficiency, slower information processing speed, and alterations in sensorimotor integration, all of which contribute to decreased movement efficiency in older adults. Functional mobility, particularly walking and transitional movements, is no longer considered a purely automatic motor task, but rather a cognitively mediated activity that requires continuous interaction between attentional resources and motor control systems. Clinically, previous studies have demonstrated that dual-task performance is strongly associated with fall risk and mobility impairment in older adults, suggesting 6 its importance in functional assessment and rehabilitation planning.Despite these advances, most of the existing research has primarily focused on binary dual-task paradigms, comparing single-task versus dual-task conditions without considering different levels of cognitive demand. This approach limits the ability to understand whether cognitive-motor interference follows a dose-response relationship, where progressively increasing cognitive load produces graded deterioration in motor performance. Furthermore, while overall gait and mobility outcomes have been widely investigated, there is a lack of detailed evidence regarding how cognitive load influences specific phases of functional mobility tasks, such as sit-to-stand, gait, turning, and stand-to-sit transitions. Previous studies suggest that different movement phases may vary in their sensitivity to cognitive interference due to differences in biomechanical and postural control demands. However, this phasespecific behavior remains underexplored, particularly in the context of graded cognitive loading.

Therefore, there is a clear gap in the literature regarding the combined effect of graded cognitive load and phase-specific motor behavior during functional mobility tasks.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

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

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Age ≥ 60 years
  • Ability to ambulate independently without assistive devices
  • Ability to follow verbal instructions and perform dual-task activities
  • Medically stable and capable of participating in functional mobility assessment Cognitive function within normal range, defined as Mini-Mental State Examination (MMSE) score ≥ 24 out of 30, indicating absence of significant cognitive impairment .
  • Functionqal independence in basic activities of daily living, defined as Barthel Index score ≥ 90 out of 100
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m², as values ≥ 30 kg/m² (obesity) may adversely affect gait and balance performance.

Exclusion Criteria:

  • Any neurological disease that affects walking or balance, such as stroke or Parkinson's disease
  • Any musculoskeletal condition that limits lower-limb movement or affects normal walking patterns
  • Severe cognitive impairment defined as Mini-Mental State Examination (MMSE) score < 24
  • Visual, vestibular, or hearing problems that affect safe walking or balance control
  • History of lower-limb injury or surgery within the last 6 months
  • Serious medical conditions that make participation unsafe, such as unstable cardiac or respiratory disease

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: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dual-Task Cognitive Loading Protocol
sixty Participants will perform the time-up-and-go test under four standardized experimental conditions designed to investigate the dose-response and phase-specific effects of graded cognitive load on functional mobility in older adults.

Participants will perform the TUG test under four standardized experimental conditions:

1. Single-Task Condition (Baseline) : Participants will perform TUG test without any additional cognitive task.

2-Low Cognitive Load Condition:Participants will perform the TUG test while simultaneously performing simple backward counting by ones starting from a randomly assigned number between 90 and 100.

3-Moderate Cognitive Load Condition :Participants will perform the TUG test while simultaneously performing serial backward counting by threes starting from a randomly assigned number between 90 and 100.

4-High Cognitive Load Condition:Participants will perform the TUG test while simultaneously performing serial subtraction by sevens (Serial 7s task) starting from a randomly assigned number between 90 and 100.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Timed Up and Go (TUG) Completion Time
Prazo: up to one day
A smartwatch will be used to assess the completion time of the TUG test. The total time required to complete the TUG test under each cognitive load condition will be recorded in seconds and used as the primary measure of functional mobility performance. Increased TUG completion time will indicate deterioration in functional mobility under cognitive interference conditions
up to one day

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
sit-to-stand phase time
Prazo: up to one day
A smartwatch will be used to assess the time of sit-to-stand phase as a part of the TUG test
up to one day
walking phase time
Prazo: up to one day
The smartwatch will be used to assess the time of the walking phase as a part of TUG test
up to one day
turning phase time
Prazo: up to one day
The smartwatch will be used to assess the time of the turning phase as a part of TUG test
up to one day
stand-to-sit phase
Prazo: up to one day
The smartwatch will be used to assess the time of the stand-to-sit phase as a part of TUG tes
up to one day
gait speed
Prazo: up to one day
A sagittal-plane video-based kinematic analysis system will be used to evaluate gait speed.ormal gait speed for healthy adults generally ranges from 1.2 to 1.4 meters per second (m/s)
up to one day
step length
Prazo: up to one day
A sagittal-plane video-based kinematic analysis system will be used to evaluate step length. The normal walking step length is about 2.5 feet (75 to 79 cm) for men and 2.2 feet (66 to 69 cm) for women
up to one day
cadence
Prazo: up to one day
A sagittal-plane video-based kinematic analysis system will be used to evaluate cadence. A normal comfortable walking cadence for healthy adults generally ranges from 100 to 120 steps per minute
up to one day
step time
Prazo: up to one day
A sagittal-plane video-based kinematic analysis system will be used to evaluate step time. the normal step time for a healthy adult walking at a comfortable, self-selected speed is approximately 0.5 seconds per single step
up to one day
turning duration
Prazo: up to one day
A sagittal-plane video-based kinematic analysis system will be used to evaluate turning duration.For healthy, normal adults, the average turning durations typically fall into these ranges from 1.4 to 1.5 seconds
up to one day
peak trunk flexion angle
Prazo: up to one day
sagittal-plane video-based kinematic analysis system will be used to evaluate peak trunk flexion.Studies show that actively flexing the trunk increases peak angles (reaching higher ranges like an added 47° in intentional flexed landings vs. preferred landings) which helps absorb impact and protect the knees
up to one day
peak hip flexion angle
Prazo: up to one day
the sagittal-plane video-based kinematic analysis system will be used to evaluate peak hip flexion angle. it should be from 130-140 degree.
up to one day
peak knee flexion angle
Prazo: up to one day
The sagittal-plane video-based kinematic analysis system will be used to evaluate peak knee flexion angle. it should be from 120-150 degree.
up to one day

Colaboradores e Investigadores

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

Patrocinador

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 (Estimado)

20 de setembro de 2026

Conclusão Primária (Estimado)

20 de fevereiro de 2027

Conclusão do estudo (Estimado)

20 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

5 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de setembro de 2026

Primeira postagem (Real)

10 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • P.T.REC/012/006633

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 .

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