- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04036383
Effects of Different Type Exercise Trainings on Functionality in Older Fallers
14 gennaio 2020 aggiornato da: Ayşe Abit Kocaman
The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Individuals participating in the study will be blinded and 30 elderly individuals will be included.
Sociodemographic information of individuals, Mini Mental State Test, Fall Efficacy Scale, Dynamic Gait Index, Montreal Cognitive Assessment Scale, Daily Life Activities Scale for Vestibular Disorders, World Health Organization Quality of Life Scale-Elderly Module test results will be recorded.
Hip flexors and abductors, m.quadriceps femoris and m.tibialis anterior muscle strength will be measured by manual muscle dynamometer.
In balance assessments; sensory organization test and adaptation test of computerized dynamic posturography will be recorded.
Individuals will be divided into 3 groups by blocking and stratification randomization method.
All individuals in the group will perform vestibular exercise training twice a day for 8 weeks as a home exercise program.
In the first group, vestibular exercise training will be used as a home program, in the second group, individual rehabilitation program will be applied to the computerized balance system and in the third group, square step exercises will be applied.
Exercise training will be held 3 times a week for 8 weeks.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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-
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Kırıkkale, Tacchino
- Kırıkkale University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
65 anni e precedenti (Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- 65 years and older individuals,
- Mini Mental State Examination Test score above 24,
- At least two falls in the last year
- Independent individuals in mobilization without walking aid
Exclusion Criteria:
- Cardiac diseases
- Pulmonary embolism and deep vein thrombosis in the last three months,
- A history of cerebral aneurysm or intracranial hemorrhage,
- Acute retinal hemorrhage or previous ophthalmic surgery,
- Active infection,
- Multiple organ failure,
- Terminal disease status,
- A history of fractures in the lower and upper extremities within the last three months,
- Severe hearing and vision loss,
- Patients with Alzheimer's disease, Parkinson's disease, dementia
- Patients diagnosed with Benign Paroxysmal Positional Vertigo,
- Those who have received exercise training in the last 6 months,
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: vestibüler
vestibular exercise training
|
The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
|
|
Sperimentale: balance training
vestibular exercise training+ balance training with computerized balance system
|
The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
|
|
Sperimentale: square-step
vestibular exercise training+ square step exercise
|
The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Balance Function Assessment-Sensory Organization Test
Lasso di tempo: 5 minutes
|
Sensory Organization Test (SOT): This is a six-part test that objectively identifies abnormalities in somatosensory, visual, and vestibular systems that provide postural control. The result is a ratio between 0-100 and 100 means perfect stability. |
5 minutes
|
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Cognitive Function assessment
Lasso di tempo: 10 minutes
|
Cognitive function will be assessed with "Montreal Cognitive Assessment Scale(MoCA)"The MoCA is a screening instrument that evaluates cognitive domains on a single page and scores range from 0 to 30."0" points indicate poor cognitive functions, "30" points indicate good cognitive functions.
Increase in scores indicates better cognitive functions.
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10 minutes
|
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Gait Function assessment
Lasso di tempo: 15 minutes
|
Dynamic Gait Index will be used to evaluate the adaptations during the patient's gait.
It evaluates activities such as slow walking, fast walking, walking with head movements, turning, stepping up, jumping obstacles, 0 points are weak and 3 points are successful.
Low scores from the scale are indicative of disorders that may cause falls.A total of 8 parameters are evaluated over 24 points.
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15 minutes
|
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Balance Function Assessment- Adaptation Test
Lasso di tempo: 5 minutes
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Adaptation Test (ADT):This test evaluates the patient's response to sudden changes and irregularities in the ground and the ability to reduce oscillations.
The oscillation energy score is obtained by measuring the force applied to the force platform for recovery.
Scores between 0 and 200.Since the maximum score given by the device is 200, the score of that test is considered as 200 in case of a fall.
The oscillation energy score is close to 0, indicating better postural adaptation.
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5 minutes
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Duque G, Boersma D, Loza-Diaz G, Hassan S, Suarez H, Geisinger D, Suriyaarachchi P, Sharma A, Demontiero O. Effects of balance training using a virtual-reality system in older fallers. Clin Interv Aging. 2013;8:257-63. doi: 10.2147/CIA.S41453. Epub 2013 Feb 28.
- Shigematsu R, Okura T, Nakagaichi M, Tanaka K, Sakai T, Kitazumi S, Rantanen T. Square-stepping exercise and fall risk factors in older adults: a single-blind, randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):76-82. doi: 10.1093/gerona/63.1.76.
- Shigematsu R, Okura T, Sakai T, Rantanen T. Square-stepping exercise versus strength and balance training for fall risk factors. Aging Clin Exp Res. 2008 Feb;20(1):19-24. doi: 10.1007/BF03324743.
- Fisseha B, Janakiraman B, Yitayeh A, Ravichandran H. Effect of square stepping exercise for older adults to prevent fall and injury related to fall: systematic review and meta-analysis of current evidences. J Exerc Rehabil. 2017 Feb 28;13(1):23-29. doi: 10.12965/jer.1734924.462. eCollection 2017 Feb.
- Moreira Bittar RS, Simoceli L, Bovino Pedalini ME, Bottino MA. The treatment of diseases related to balance disorders in the elderly and the effectiveness of vestibular rehabilitation. Braz J Otorhinolaryngol. 2007 May-Jun;73(3):295-8. doi: 10.1016/s1808-8694(15)30071-9.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
31 dicembre 2018
Completamento primario (Effettivo)
1 agosto 2019
Completamento dello studio (Effettivo)
1 gennaio 2020
Date di iscrizione allo studio
Primo inviato
12 luglio 2019
Primo inviato che soddisfa i criteri di controllo qualità
26 luglio 2019
Primo Inserito (Effettivo)
29 luglio 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 gennaio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 gennaio 2020
Ultimo verificato
1 gennaio 2020
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- FALL AND SQUARE STEP EXERCİSE
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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