- ICH GCP
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- Essai clinique NCT03522389
Effect of Action Observation Training on Gait Variables and Global Cognitive Functions
The Effect of Action Observation Training on Gait Variables and Global Cognitive Functions in Older Adult With Mild Cognitive Impairment: A Randomized Controlled Trial
This study will investigate the effect of Action Observation Teaining (AOT) on gait variables and global cognitive functions in older adults with mild cognitive impairment (MCI).
The specific objectives are 1) to compare gait variables and global cognitive functions among the AOT with gait training, gait training, and control groups at before training, after training, and follow up and 2) to compare gait variables and global cognitive functions among before training, after training, and follow up in each of the groups.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants in this study will be older adults recruiting from the Physical Therapy Center of Mahidol University, Siriraj hospital, and community at Phuttamonthon area (n = 39).
They will be diagnosed as a MCI, using core clinical criteria of the National Institute on Aging and the Alzheimer's Association by a physiotherapist. Prior to participate in the study, participants will be informed the details of the study and sign the informed consent. All participants will be recorded the demographic data and will be assessed visual acuity, hearing, sensation and muscle strength of lower extremity, balance, gait variables, and global cognitive function.
Participants who pass the criteria will be randomly assigned to either the AOT with gait training group (n = 13), the gait training group (n = 13), and the control group (n = 13) by stratified randomization.
Gait variables will be collected by the Force Distribution Measurement platform during walking at comfortable speed (single task) and during counting backwards from 100 by sevens (dual tasks). Global cognitive function will be assessed by the Montral Cognitve Assessment (MoCA).
All varaibles will be assessed 3 times which will be at before training, after 4-week of training, and 4-week follow-up.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged 60-80 years old.
- Having subjective evidence of cognitive decline from patients, or from closely informants, or from a clinicians.
- Having objective evidence of cognitive decline, defined by using a Montreal Cognitive Assessment (MoCA) 18-24 points.
- Independent function in daily life
- Independent walking without using gait aids.
- Having fall risk, defined by the fall risk threshold (gait velocity < 1 m/s in walking while counting backwards from 100 by sevens).
- Able to understand Thai language and follow study protocol.
Exclusion Criteria:
- Having history of stroke or heart attack or Parkinsonism symptoms.
- The presence of major depression disorder defined by a Patient Health Questionnaire-9 > 9 points.
- Diagnosis as dementia by neurologists.
- Any cardiac or respiratory disease that could cause gait limiting.
- Musculoskeletal disorder that affected gait performance.
- Balance disorder in assessment day, such as vertigo and dizziness.
- Visual acuity with a glasses worse than 6/15 (metric system) in both their eyes.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: AOT with gait training group
Action observation training with gait training
|
AOT with gait training composes of program of watching video in different views of normal walk for 5 min. After that, participants will receive gait training program. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome. |
Comparateur actif: Gait training group
Gait training
|
To control a total time of training, the gait training group will watch video of Vincent van Gogh's painting for 5 min. After that, participants will training the gait as protocol of experimental group. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome. |
Autre: Control group
Education
|
There will be no intervention exercise program provide for the control group.
They will receive education about dementia such as definition, etiology, sign and symptom, and caring.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changed score of stride time variability in single-task condition
Délai: 8 weeks
|
Stride time variability in self-selected speed of walking.
It is duration between successive points of heel contact of the same foot.
The coeffcient of variation (CV), which measures the variability of stride time, will be calculated as a ratio of the standard deviation of the mean stride time to the mean stride time multiplied by 100.
|
8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changed score of stride time variability in dual -task condition
Délai: 8 weeks
|
Stride time variability in walking while counting backwards from 100 by sevens.
It is duration between successive points of heel contact of the same foot.
The coeffcient of variation (CV), which measures the variability of stride time, will be calculated as a ratio of the standard deviation of the mean stride time to the mean stride time multiplied by 100.
|
8 weeks
|
Changed score of gait velocity in single-task condition
Délai: 8 weeks
|
It will be calculated from distance divided by time.
|
8 weeks
|
Changed score of gait velocity in dual -task condition
Délai: 8 weeks
|
Gait velocity in walking while counting backwards from 100 by sevens, will be calculated from distance divided by time.
|
8 weeks
|
Changed score of MoCA
Délai: 8 weeks
|
Global cognitive functions will be collected using a Montreal Cognitive Assessment (MoCA)
|
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rommanee Rojasavastera, Faculty of Physical Therapy, Mahidol University
Publications et liens utiles
Publications générales
- Montero-Odasso M, Muir SW, Speechley M. Dual-task complexity affects gait in people with mild cognitive impairment: The interplay between gait variability, dual tasking, and risk of falls. Arch Phys Med Rehabil. 2012;93(2):293-9. Park H, Kim J, Lee M, Oh D. Clinical feasibility of action observation training for walking function of patients with post-stroke hemiparesis: a randomized controlled trial. Clin Rehabil. 2014;28(8):794-803. Scherder E, Eggermont L, Visscher C, Scheltens P, Swaab D. Understanding higher level gait disturbances in mild dementia in order to improve rehabilitation: 'Last in-first out'. Neurosci Biobehav Rev. 2011;35(3):699-714. Beauchet O, Launay CP, Annweiler C, Allali G. Hippocampal volume, early cognitive decline and gait variability: Which association? Exp Gerontol. 2015;61:98-104.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MU-CIRB 2018/001.0301
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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