- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07775183
The Effects of Light-Targeted Balance Training on Balance, Functional Performance, and Fear of Falling in Individuals With a History of Falls
The Effects of Light-Targeted Balance Training on Balance, Functional Performance, and Fear of Falling in Individuals With a History of Falls: A Randomized Controlled Trial
In recent years, exercise programs based on visual stimuli have been reported to improve balance and motor control . However, studies investigating the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls are limited.
The aim of this study is to determine the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls. In addition, the study aims to investigate whether this training method provides additional benefits compared with traditional balance training. The findings of this study are expected to contribute to the development of rehabilitation programs aimed at preventing falls.
Přehled studie
Postavení
Podmínky
Detailní popis
Inclusion Criteria
- Having experienced at least one fall within the previous 12 months.
- Being 18 years of age or older.
- Being able to walk independently or with the assistance of a walking aid.
- Being able to understand and follow verbal and visual instructions.
- Providing voluntary consent to participate in the study and signing the informed consent form.
Exclusion Criteria
- Presence of an acute orthopedic injury or an active musculoskeletal condition causing pain.
- Having undergone lower extremity surgery within the previous 6 months.
- Having advanced neurological disorders (e.g., advanced Parkinson's disease, advanced dementia).
- Having severe vestibular dysfunction or significant visual impairment.
- Having a cardiovascular condition that contraindicates exercise.
- Having advanced systemic diseases that significantly impair balance.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Shirin Khezritomatari
- Telefonní číslo: +905342494709
- E-mail: shirin.khezry8401@gmail.com
Studijní místa
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-
Istanbul
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Istanbul, Istanbul, Turecko (Türkiye), 34000
- Nábor
- Uskudar University
-
Kontakt:
- Shirin Khezritomatari, Master student
- Telefonní číslo: +905342494709
- E-mail: Shirin.khezry8401@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- History of at least one fall within the past 12 months
- Age 18 years or older
- Ability to walk independently or with an assistive device
- Ability to understand and follow verbal and visual instructions
- Voluntary participation in the study and provision of written informed consent by signing the informed consent form
Exclusion Criteria:
- Acute orthopedic injury or an active musculoskeletal condition causing pain
- History of lower extremity surgery within the past 6 months
- Advanced neurological disorders (e.g., advanced Parkinson's disease, advanced dementia)
- Severe vestibular dysfunction or significant visual impairment
- Medical conditions that contraindicate exercise due to severe cardiovascular disease
- Advanced systemic diseases that severely affect balance
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Experimental Group
Participants in this group will receive light-targeted balance training in addition to the standard program.
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Exercises aimed at improving coordination, balance, and functional performance using visual and auditory cues.
|
|
Aktivní komparátor: Control Group
Participants in this group will receive standard balance exercises.
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Conventional balance training exercises.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Balance Performance (Berg Balance Scale)
Časové okno: Baseline and after 8 weeks of intervention
|
Balance performance is assessed using the Berg Balance Scale (BBS).
The scale consists of 14 functional tasks scored from 0 to 4. The total score ranges from 0 to 56, where higher scores indicate better balance and lower fall risk.
|
Baseline and after 8 weeks of intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Functional Mobility (Timed Up and Go Test - TUG)
Časové okno: Baseline and after 8 weeks of intervention
|
Dynamic balance and mobility are assessed using the Timed Up and Go (TUG) test.
The time (in seconds) taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down is recorded.
Shorter completion times indicate better mobility.
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Baseline and after 8 weeks of intervention
|
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Change in Dynamic Balance (Y-Balance Test)
Časové okno: Baseline and after 8 weeks of intervention
|
Dynamic postural control is evaluated using the Y-Balance Test (YBT) in anterior, posteromedial, and posterolateral reach directions for both lower extremities.
Reach distance is normalized to limb length ((reach distance / limb length) x 100) and composite scores are calculated.
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Baseline and after 8 weeks of intervention
|
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Change in Lower Body Strength (30-Second Chair Stand Test)
Časové okno: Baseline and after 8 weeks of intervention
|
Lower extremity functional muscle strength is measured using the 30-Second Chair Stand Test.
The total number of full stands completed from a seated position in 30 seconds is recorded.
A higher number of repetitions indicates greater lower body strength.
|
Baseline and after 8 weeks of intervention
|
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Change in Gait Speed (10-Meter Walk Test - 10MWT)
Časové okno: Baseline and after 8 weeks of intervention
|
Walking speed is assessed using the 10-Meter Walk Test (10MWT).
Participants walk a 10-meter course at their comfortable and/or fast walking pace, and the time taken (in seconds) to traverse the intermediate 6 meters is recorded to calculate gait speed (m/s).
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Baseline and after 8 weeks of intervention
|
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Change in Fear of Falling (Falls Efficacy Scale-International - FES-I)
Časové okno: Baseline and after 8 weeks of intervention
|
Fear of falling is evaluated using the 16-item Falls Efficacy Scale-International (FES-I).
Each item is scored on a 4-point Likert scale from 1 (not at all concerned) to 4 (very concerned).
Total score ranges from 16 to 64, with higher scores reflecting greater fear of falling.
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Baseline and after 8 weeks of intervention
|
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Change in Balance Confidence (Activities-specific Balance Confidence Scale - ABC)
Časové okno: Baseline and after 8 weeks of intervention
|
Balance confidence is measured using the 16-item Activities-specific Balance Confidence (ABC) Scale.
Participants rate their confidence in performing specific activities without losing balance on a scale from 0% to 100%.
The overall score is the mean percentage across all items.
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Baseline and after 8 weeks of intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 61351342/020-2288
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