- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Punjab Province
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Lahore, Punjab Province, Pakisztán, 54000
- UMT (University of Management and Technology)
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Kapcsolatba lépni:
- Maham Khalid, M.Phil
- Telefonszám: +923244467622
- E-mail: maham.khalid@umt.edu.pk
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Alkutató:
- Memoona Bibi, MSPT
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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. |
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Kísérleti: 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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Berg Balance Scale (for risk of fall)
Időkeret: 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)
Időkeret: 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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Együttműködők és nyomozók
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- RE-206-2026
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
The results data collected, de-identified individual participant data will be shared.
IPD megosztási időkeret
6 months after the publication of the manuscript.
IPD-megosztási hozzáférési feltételek
The data can be requested from the corresponding author.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
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