- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07814053
Dose-Response and Phase-Specific Effects of Graded Cognitive Load on Functional Mobility in Older Adults: A Kinematic Analysis (CL)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: mostafa seliem, master
- Numéro de téléphone: 01554049062
- E-mail: mostafasleim92@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Timed Up and Go (TUG) Completion Time
Délai: 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
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up to one day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
sit-to-stand phase time
Délai: 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
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up to one day
|
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walking phase time
Délai: up to one day
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The smartwatch will be used to assess the time of the walking phase as a part of TUG test
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up to one day
|
|
turning phase time
Délai: up to one day
|
The smartwatch will be used to assess the time of the turning phase as a part of TUG test
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up to one day
|
|
stand-to-sit phase
Délai: 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
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up to one day
|
|
gait speed
Délai: 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)
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up to one day
|
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step length
Délai: 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
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up to one day
|
|
cadence
Délai: 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
Délai: 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
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up to one day
|
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turning duration
Délai: 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
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up to one day
|
|
peak trunk flexion angle
Délai: 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
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up to one day
|
|
peak hip flexion angle
Délai: 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.
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up to one day
|
|
peak knee flexion angle
Délai: 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
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- P.T.REC/012/006633
Informations sur les médicaments et les dispositifs, documents d'étude
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