- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07596225
Effects of Kinect-Based Exergaming Versus Wii Fit Training on Balance and Fall Risk Among Healthy Older Adults
Study, titled Effects of Kinect-Based Exergaming versus Wii Fit on Balance and Fall Risk among Healthy Older Adults, is a randomized controlled trial comparing the balance training effects of Xbox Kinect and Wii Fit.
After obtaining informed consent, 46 healthy older adults will be randomly allocated (1:1) using sealed envelopes to a 6-week training program in either group. Static, Dynamic, and Anticipatory balance will be assessed at baseline and post-intervention using the Biodex Balance System for objective comparison.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Balance is a complex, multidimensional concept related to postural control, referring essentially to the ability to maintain a stable posture. Each year, an estimated 37.3 million individuals experience a fall that requires hospitalization and may lead to severe injuries, such as fractures and traumatic brain injuries. Traditional balance exercises reduce fall risk but may have low long-term adherence in seniors. The introduction of VR-based games engages participants in interactive balance exercises.
The objective of this study is to evaluate the effects of Kinect-based exergaming compared to Wii Fit balance training on reducing fall risk in elderly individuals, focusing on parameters of Fall incidence, as well as Static, Dynamic, and Anticipatory balance.
The study will be a non-blinded Randomized Controlled Trial (RCT), consisting of 2 groups. The Study will be conducted over 1 year at the Multidisciplinary Development Lab (MDL) of the Foundation University College of Physical Therapy (FUCP).
A calculated sample of 46 subjects will be selected via a non-probability convenience sampling technique, followed by randomization in a 1:1 ratio to Group A (Kinect-based exergaming) or Group B (Wii Fit) using the sealed-envelope method.
After CBRC registration, ethical approval will be obtained from the Ethical Review Commitee (ERC) of Foundation University Medical College (FUMC).
Individuals fulfilling the inclusion criteria will be selected, followed by written informed consent after explaining the study purpose. Participants will then be randomly allocated to one of the 2 groups.
At baseline, investigators will assess postural control using the Postural Stability System and balance confidence using the Falls Efficacy Scale. Objective static and dynamic balance will be evaluated using the Berg Balance Scale, while cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA).
One group will be provided with Kinect-based exer-gaming balance training. The second group will be provided with the Wii Fit Balance Training. Exercise training would be performed over a 6-week intervention period, administering exercise training 3 days per week. All outcome measurements would be performed before and after the 6-week intervention period. Data will be entered and analyzed on SPSS v. 22.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Nayab Khan, DPT
- Telefonní číslo: 03379234059
- E-mail: khannayyab0202@gmail.com
Studijní záloha kontaktů
- Jméno: Muhammad Ehab Azim, PhD
- Telefonní číslo: 03155330080
- E-mail: ehab@fui.edu.pk
Studijní místa
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Punjab Province
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Islamabad, Punjab Province, Pákistán, 44000
- Nábor
- Foundation University College of Physical Therapy
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Kontakt:
- Nayab Khan, DPT
- Telefonní číslo: 03379234059
- E-mail: khannayyab0202@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Older adults aged ≥55, community-dwelling, with a BBS score between 21-50, including both mild to moderate Risk falls
- Able to stand without assistive devices
- Cognitively able to follow instructions, with a MoCA score ≥ 22
- Both Genders: Males and females
Exclusion Criteria:
- History of Neurological disorders affecting balance (e.g., Parkinson's disease, stroke)
- Acute Vestibular disorders/Major Musculoskeletal impairments (e.g., Arthritis)
- Participation in other balance training programs within the past 6 months
- Any condition posing a safety risk (e.g., severe osteoporosis, uncontrolled hypertension
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Group A
Participants in this group will engage in four interactive mini-games from the Kinect Adventures collection, specifically selected for their dynamic full-body demands: Games will be
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The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40- 50 minutes/day (18). Group 1 will receive Kinect-based exergaming balance training. Warm-up exercise will be for 5 minutes, including gentle stretching exercises, and 5 minutes will be given for a cool down, including deep breathing exercises Group (A) / (Kinect-based Exergaming balance training):
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Experimentální: Group B
Participants in this group will engage in four interactive games , specifically selected for their dynamic full-body demands.These games collectively target key balance components,static control, dynamic adjustment, and anticipatory balance Games will be
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The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40- 50 minutes/day (18). Group 2 will receive Wii Fit balance training. Warm-up exercise will be for 5 minutes, including gentle stretching exercises, and 5 minutes will be given for a cool down, including deep breathing exercises Group (B) / Wii Fit balance training:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postural stability
Časové okno: 6 weeks.
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Static postural stability will be assessed using the Biodex Balance System SD at stability level 12. The Overall Stability Index (OSI) measures the variance of platform displacement during static standing. The Overall Stability Index (OSI) is expressed in degrees. Lower OSI values indicate better postural stability and reduced postural sway, whereas higher values indicate impaired balance control. Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes |
6 weeks.
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Balance
Časové okno: 6 weeks
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Berg Balance scale will be used.
5-point ordinal scale (graded 0-4), Max score = 56 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk R=0.88-0.98.
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6 weeks
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Concern of Fall
Časové okno: 6 weeks
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Fall Efficacy Scale will be used. 16 items Questionnaire. Individuals are instructed to score their concern of falling during an activity. Performed at the start of the treatment protocol, and after 8 weeks at the end of the intervention 1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total of 64. 16 = no concern about falling, > 16 = concern about falling |
6 weeks
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Cognition
Časové okno: 6 weeks
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Montreal Cognitive Assessment (MoCA) A 30-item global cognitive screening tool scored from 0-30. Higher scores indicate better cognition. 26-30: Normal cognition 18-25: Mild cognitive impairment (MCI) 10-17: Moderate cognitive impairment ≤ 9: Severe cognitive impairment One extra point is added for individuals with ≤12 years of formal education to adjust for educational bias |
6 weeks
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Dynamic balance
Časové okno: 6 weeks
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Dynamic balance will be assessed using the Biodex Balance System SD at stability level 6 under unstable surface conditions. Balance performance will be quantified using the Overall Stability Index (OSI). The Overall Stability Index (OSI) is expressed in degrees.Lower OSI scores represent improved dynamic balance and neuromuscular control, whereas higher values indicate poorer balance performance. Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes |
6 weeks
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Limits of Stability
Časové okno: 6 weeks
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Limits of Stability testing will be used to assess the participant's ability to intentionally displace the center of pressure toward visual targets without losing balance. Higher LOS scores indicate better anticipatory postural control and balance performance, whereas lower scores indicate impaired balance ability. Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes |
6 weeks
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Fall Risk Index
Časové okno: 6 week
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The Fall Risk Test using the Biodex Balance System will assess the participant's risk of falls under progressively unstable conditions. Higher Fall Risk Index scores indicate greater fall risk and poorer balance ability, whereas lower scores indicate improved balance and reduced fall risk. Assessment will be performed at baseline and after 6 weeks of intervention. |
6 week
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Nayab Khan, DPT, Foundation University Islamabad
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
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
- FUI/FUCP/CTR/Neuro2/Nayyab
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Klinické studie na Virtual Reality Balance Training
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