- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- UMT (University of Management and Technology)
-
Contatto:
- Maham Khalid, M.Phil
- Numero di telefono: +923244467622
- Email: maham.khalid@umt.edu.pk
-
Sub-investigatore:
- Memoona Bibi, MSPT
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Berg Balance Scale (for risk of fall)
Lasso di tempo: Baseline and after 6 weeks
|
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
|
|
MiniBESTest (for Reactive Balance)
Lasso di tempo: Baseline and after 6 weeks
|
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
|
Collaboratori e investigatori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- RE-206-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The results data collected, de-identified individual participant data will be shared.
Periodo di condivisione IPD
6 months after the publication of the manuscript.
Criteri di accesso alla condivisione IPD
The data can be requested from the corresponding author.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .