- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07920432
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
Comparative Effects of Sensory Perturbation and Dual-Task Training in Combination With Square-Stepping Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
This randomized clinical trial is comparing the effects of sensory perturbation and dual task training in combination with square-stepping exercises on reactive balance and fall risk in community-dwelling older adults. Thirty-four (34) older adults who will meet inclusion criteria will be recruited by using non-probability convenient sampling from an old age home. A complete physical history and data of demographic characteristics (age, height, weight, BMI etc.) will be collected from the participants. For intervention participants will be randomly allocated into two groups i.e., A and B. Group A will receive square-stepping exercises with sensory perturbation for 30 minutes, 3 sessions per week for 6 weeks. Group B will receive square-stepping exercises with dual task training for 30 minutes, 3 sessions per week for 6 weeks. Both groups will also receive conventional training for 30 minutes. Measurements of fall risk and reactive balance will be taken at baseline and at 6th week.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- UMT (University of Management and Technology)
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Kontakt:
- Maham Khalid, M.Phil
- Telefonní číslo: +923244467622
- E-mail: maham.khalid@umt.edu.pk
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Dílčí vyšetřovatel:
- Memoona Bibi, MSPT
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Aged 60-85 years Both males and females Can walk independently with or without an assistive device Fall efficacy scale = 9-13 TUG =10.9 + 3.9 (20) For cognitive functions: MMSE = 24-30 Must be community-dwelling
Exclusion Criteria:
Older adults with neurological conditions and sensori-motor impairments. Severe musculoskeletal impairments e.g., recent fracture Vestibular disorders e.g., Benign Paroxysmal Positional Vertigo (BPPV). Severe visual impairment due to diabetic retinopathy or cataracts. Cardiovascular or cardiopulmonary instability. (Only if the condition could impair their ability to cooperate or is associated with rapid deterioration).
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: Square Stepping Exercises (SSE) with Sensory Perturbation
Participants perform square stepping exercise (SSE): stepping pattern in forward, backward, lateral, and diagonal directions on thin mat (250 cm x 100 cm) partitioned into 40 squares (25 cm x 25 cm). After instructor's demonstration, participants memorize and practice each pattern in a supervised group. For sensory perturbation, foam pieces are randomly placed under mat, hidden from participants, creating unpredictable surface that challenges somatosensory input and reactive balance. Foam positions are changed in each session. Pattern difficulty is progressed by increasing complexity of pattern. Session last 30 minutes, 3 per week for 6 weeks. Participants also receive 30 minutes of ACSM-based balance training per session: progressive reduction of base of support (two-legged to one-legged stands); dynamic movements perturbing center of gravity (tandem, toe, heel, sideways walking; raising leg with contralateral arm); heel and toe stands. An instructor supervises all sessions. |
Participants perform square stepping exercise (SSE): stepping pattern in forward, backward, lateral, and diagonal directions on thin mat (250 cm x 100 cm) partitioned into 40 squares (25 cm x 25 cm). After instructor's demonstration, participants memorize and practice each pattern in a supervised group. For sensory perturbation, foam pieces are randomly placed under mat, hidden from participants, creating unpredictable surface that challenges somatosensory input and reactive balance. Foam positions are changed in each session. Pattern difficulty is progressed by increasing complexity of pattern. Session last 30 minutes, 3 per week for 6 weeks. Participants also receive 30 minutes of ACSM-based balance training per session: progressive reduction of base of support (two-legged to one-legged stands); dynamic movements perturbing center of gravity (tandem, toe, heel, sideways walking; raising leg with contralateral arm); heel and toe stands. An instructor supervises all sessions. |
|
Experimentální: Square Stepping Exercises (SSE) with Dual-Task Training
Participants perform square stepping exercise (SSE): stepping pattern in forward, backward, lateral, and diagonal directions on thin mat (250 cm x 100 cm) partitioned into 40 squares (25 cm x 25 cm). After instructor's demonstration, participants memorize and practice each pattern in a supervised group. For dual-task training, participants say aloud as many as words possible from a given category (e.g., animals, fruits) while performing one pattern, without repeating words. Categories change with each pattern and progress from general to specific; pattern complexity also increases. Session last 30 minutes, 3 per week for 6 weeks. Participants also receive 30 minutes of ACSM-based balance training per session: progressive reduction of base of support (two-legged to one-legged stands); dynamic movements perturbing center of gravity (tandem, toe, heel, sideways walking; raising leg with contralateral arm); heel and toe stands. An instructor supervises all sessions. |
Participants perform square stepping exercise (SSE): stepping pattern in forward, backward, lateral, and diagonal directions on thin mat (250 cm x 100 cm) partitioned into 40 squares (25 cm x 25 cm). After instructor's demonstration, participants memorize and practice each pattern in a supervised group. For dual-task training, participants say aloud as many as words possible from a given category (e.g., animals, fruits) while performing one pattern, without repeating words. Categories change with each pattern and progress from general to specific; pattern complexity also increases. Session last 30 minutes, 3 per week for 6 weeks. Participants also receive 30 minutes of ACSM-based balance training per session: progressive reduction of base of support (two-legged to one-legged stands); dynamic movements perturbing center of gravity (tandem, toe, heel, sideways walking; raising leg with contralateral arm); heel and toe stands. An instructor supervises all sessions. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Berg Balance Scale (for risk of fall)
Časové okno: Baseline and after 6 weeks
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The Berg Balance Scale (BBS) has 14 items in daily life activities and living settings to evaluate a fall risk. Each item ranges from 0 to 4. The total score is used to classify the fall risk into 3 groups: high-risk group (0-20 points), moderate-risk group (21-40 points), and low-risk group (41-56 points). |
Baseline and after 6 weeks
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MiniBESTest (for Reactive Balance)
Časové okno: Baseline and after 6 weeks
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The Balance Evaluation Systems Test1 (BESTest) was developed to identify the postural control system(s) that underly poor functional balance, enabling physiotherapists to target treatment to a person's specific balance deficit. The Mini-BESTest includes four subscales: transitions/anticipatory postural control, reactive postural control, sensory orientation and stability in gait. Each item is rated on a three-point ordinal scale (0 = severe to 2 = normal). |
Baseline and after 6 weeks
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Užitečné odkazy
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
- RE-206-2026
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
The results data collected, de-identified individual participant data will be shared.
Časový rámec sdílení IPD
6 months after the publication of the manuscript.
Kritéria přístupu pro sdílení IPD
The data can be requested from the corresponding author.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
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