- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- UMT (University of Management and Technology)
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Contacto:
- Maham Khalid, M.Phil
- Número de teléfono: +923244467622
- Correo electrónico: maham.khalid@umt.edu.pk
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Sub-Investigador:
- Memoona Bibi, MSPT
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Berg Balance Scale (for risk of fall)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RE-206-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The results data collected, de-identified individual participant data will be shared.
Marco de tiempo para compartir IPD
6 months after the publication of the manuscript.
Criterios de acceso compartido de IPD
The data can be requested from the corresponding author.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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