- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07620509
Usefulness of a Virtual Response Test as a Predictor of Functional and Cognitive Abilities in Older Adults With Different Degrees of Cognitive Impairment: a Pilot Study (ReactVR) (ReactVR)
BACKGROUND Population aging is one of the most significant trends of the 21st century.In 2020, 21% of the European population was 65 years of age or older, compared to 16% in 2001.Today, 1 in 9 people is over 60, but it is estimated that by 2050, this will be 1 in 5. Therefore, population aging is a phenomenon that can no longer be ignored. In recent decades, the increase in the number of older people is due to the increase in life expectancy. By 2026, the average life expectancy for men is estimated at 77.65 years, and for women, values are projected to reach 85.5 years.
Aging is generally associated with neuromuscular deterioration (such as sarcopenia), gait and balance disorders and loss of mobility. In general, a loss of functional independence. In the population over 60 years of age, approximately 3% of muscle strength is lost per year due to muscle denervation and the conversion of type II muscle fibers to type I muscle fibers, decreasing their muscle power for performing activities of daily living. This muscle weakness eventually leads to frailty in older adults, and, consequently, an increased rate of falls and fractures.
Cognitive ability is also closely related to motor ability, since there are cognitive requirements for developing all physical functions and balance, and these can be altered when attention is diverted or reduced. Executive function and processing speed are some of the cognitive functions related to postural stability, which can be impaired in older adults with cognitive decline. Cognitive decline and dementia are geriatric syndromes with a fairly high incidence. Around 7% of those over 65 years of age are affected. affected, a percentage that increases to 50% for people over 80 years old, which means that more than 1.5 million people in Spain directly suffer from this condition.
Furthermore, the risk of falls is linked to reaction times, which involve both cognitive and motor aspects (discussed above). These combine attention, perception, and information integration with the final motor response, as well as psychological and emotional factors such as fear of falling or insecurity. Currently, one in three adults over 65 and one in two adults over 80 fall each year, making it a serious public health problem among older adults, as falls lead to premature mortality, loss of independence, and admission to assisted living facilities.
A widely used scale for predicting the risk of falls is the Time Up and Go (TUG) test. The patient is asked to stand up from a seated position, walk three meters, turn around, and return to the starting position while the time is measured. Patients who do not complete the test in less than 13.5 seconds are considered to have a high risk of falls. Although it is included in various clinical guidelines, the literature recommends identifying alternative tools that can more accurately identify patients at risk of falls, as several studies have shown that the accuracy of this test is limited. Within the TUG (Trauma Glide Test), we have the cognitive TUG (TUG-cog), which assesses the previous test but with the interference of a concurrent cognitive activity. In neurological processes, such as Alzheimer's disease, deficits in divided attention and the ability to perform dual tasks appear to be related to functional mobility impairments, directly linked to the risk of falls.
Currently, there are also simple reaction time tests (SRTT), which consist of a computerized test to measure a person's reaction times by pressing a response button with the index finger of their dominant hand. However, there is controversy regarding the influence of motor disability on performance in the computerized SRTT task assessment, since the response depends on the ability to press a key with a finger.
The use of virtual reality software could facilitate the measurement of reaction times in performing functional tasks-tasks that require greater upper limb mobility, which can be a key factor in preventing falls-without being limited to measuring the movement of a single finger.
- HYPOTHESES AND OBJECTIVES H0: Knowing the functional reaction times assessed with virtual reality does not help to understand the integrity of the physical, functional, and cognitive abilities of older adults with cognitive impairment, nor can it predict their risk of falling or their level of cognitive impairment.
1) General Objective 1.1 To determine the feasibility of using a virtual reaction time test (VRTT) as a predictor of falls and the level of cognitive impairment in older adults with cognitive impairment.
2) Specific Objectives 2.1 To analyze the relationship between the VRTT and the risk of falling as measured by the Timed Up and Go (TUG) Test. 2.2 Analyze the relationship between VRTT obtained in the virtual test and the level of cognitive impairment measured with the Cambridge Cognitive Examination (CAMCOG). 2.3 Estimate TUG and CAMCOG scores based on reaction times obtained in the VRTT
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Pontevedra
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Vigo, Pontevedra, Španělsko, 36316
- University of Vigo
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- age ≥65 years
- membership in a patient association with cognitive impairment
- signed informed consent
Exclusion Criteria:
- cardiovascular, pulmonary or musculoskeletal pathology that limits the evaluation
- inability to understand instructions
- severe sensory impairment, vertigo, epilepsy or uncontrolled psychosis
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Virtual reaction time test Group
The intervention will consist of a single session measuring virtual reaction times using Rezill software
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A measurement is taken using the Rezzil reaction time test (measured in milliseconds).
This software comprises a collection of training games designed to improve physical and cognitive performance across a wide range of sports within an immersive virtual reality environment.
In microwall mode, a 3x3 grid is presented, and the objective is to respond to a random stimulus projected onto it with a rapid limb movement, making several attempts over 45 seconds.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Virtual reality reaction time test
Časové okno: Baseline
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A measurement is taken using the Rezzil reaction time test (measured in milliseconds). This software comprises a collection of training games designed to improve physical and cognitive performance across a wide range of sports within an immersive virtual reality (VR) environment. In microwall mode, a 3x3 grid is presented, and the objective is to respond to a random stimulus projected onto it with a rapid limb movement, making several attempts over 45 seconds. The average reaction time is recorded |
Baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Level of cognitive impairment assessed using the Global Deterioration Scale (GDS)
Časové okno: Baseline
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GDS is is a 7-stage clinical assessment tool used to measure the progression of cognitive decline and dementia. The scale breaks down cognitive health into the following stages: Stage 1: No Cognitive Decline. Stage 2: Very Mild Cognitive Decline. Stage 3: Mild Cognitive Decline. Stage 4: Moderate Cognitive Decline. Considered early dementia. Stage 5: Moderately Severe Cognitive Decline. Middle dementia stage. Stage 6: Severe Cognitive Decline. Dementia Stage 7: Very Severe Cognitive Decline. Late-stage dementia. |
Baseline
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Level of cognitive ability assessed using the Cambridge Cognitive Examination-Revised (CAMCOG-R) test
Časové okno: Baseline
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The CAMCOG-R is a comprehensive neuropsychological test designed to evaluate cognitive impairment and assist in diagnosing dementia. Total score ranges from 0 to 105 points, with higher scores indicating better cognitive function. The CAMCOG-R thoroughly evaluates 8 core neurological and cognitive domains:Orientation (10 points): Measures awareness of time, date, and location.Language (30 points): Tests comprehension, naming, reading, writing, and verbal fluency.Memory (27 points): Assesses remote memory, recent memory, and learning ability (including delayed recall).Attention and Calculation (9 points): Evaluates working memory and arithmetic skills.Praxis (12 points): Tests motor planning through tasks like copying shapes or mimicking actions (e.g., folding paper).Abstraction (8 points): Measures problem-solving and the ability to understand similarities.Perception (9 points): Assesses visual perception and spatial recognition.Executive Function: Evaluates higher-order organization |
Baseline
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Gait functionality measured with the Timed Up and Go Test (TUG test)
Časové okno: Baseline
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The TUG test is a quick, functional assessment used by physical therapists and healthcare providers to measure a person's mobility, balance, and fall risk. The test records how long it takes to stand from a chair, walk 3 meters, turn, and sit back down. Results are evaluated based on the time taken to complete the task: <10 Seconds: Normal, independent mobility. 10 to 12 Seconds: Indicates a moderate risk of falling. 12 to 14 Seconds: Indicates a high risk of falling. >20 Seconds: Poor functional mobility; often requires further assessment for outside mobility and assistive devices. >30 Seconds: Indicates significant mobility impairment and dependency. |
Baseline
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HEALTHYFIT-UVIGO 2/2026
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