- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07608991
Effects of Combined Cervical and Oculomotor Exercises on Dynamic Balance in Elderly
This study focuses on improving balance in elderly individuals (aged 60-80 years) who may experience dizziness or instability while walking or performing daily activities. Poor balance increases the risk of falls, which can lead to serious injuries and loss of independence.
The study compares two types of exercise programs:
One group performs combined cervical (neck) exercises + eye (oculomotor) exercises + Otago balance exercises The other group performs eye (oculomotor) exercises + Otago balance exercises only These exercises are done 3 times per week for 6 weeks, with each session lasting 30-45 minutes.
The goal is to determine whether combining neck and eye exercises improves balance more effectively than eye exercises alone.
This research may help:
Reduce fall risk in elderly people Improve mobility and independence Provide better rehabilitation programs for physiotherapists
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Islamabad, Pakistán, 44000
- Foundation University College of Physical Therapy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male and female participants aged 60-80 years.
- DHI-mild score(0-30)
- Ability to follow instructions and participate in exercises.
- BBS moderate (21-40)
- Normal to corrected vision
- Negative Dix Hallpike
Exclusion Criteria:
- Diagnosed vestibular disorders
- Neurological or musculoskeletal conditions affecting balance.
- Patients with VBI
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: occulomotor exercises with otago exercises group B
Frequency: 3 sessions/week | Duration: 30-45 min * Week 1-2: Eye exercises 10-12 reps, VOR x1 (30-40 sec), basic balance training, walking 5-12 min * Week 3-4: Eye exercises 12-15 reps, VOR x1→x2 (1 min), moderate balance training, walking 12-15 min * Week 5-6: Eye exercises 15-20 reps, VOR x1+x2 (1-2 min), advanced balance training, walking 15-20 min |
Smooth pursuit exercises, where the eyes follow a moving target horizontally, vertically, and diagonally while keeping the head still. Saccadic eye movements, involving quick shifts of gaze between two stationary targets. Gaze stability (VOR x1 and VOR x2) exercises, involving head movements while maintaining focus on a target, and moving the head and target in opposite directions. All participants will perform the Otago exercise program, a well-established, evidence-based fall prevention program focusing on lower limb strengthening and dynamic balance. It includes:
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Experimental: Group A (Cervical + Oculomotor + Otago)
Cervical ROM 10-12 reps, chin tuck 5-7 sec ×10, isometrics 5-6 sec ×5-6, eye exercises 10-12 reps, VOR x1 (30-40 sec), walking 5-12 min * Week 3-4: Cervical ROM 12-15 reps, chin tuck 8-10 sec ×12, isometrics 7-8 sec ×8-10, eye exercises 12-15 reps, VOR x1→x2 (1 min), walking 12-15 min * Week 5-6: Cervical ROM 15-20 reps, chin tuck 10-12 sec ×15, isometrics 10 sec ×10-12, eye exercises 15-20 reps, VOR x1+x2 (1-2 min), walking 15-20 min |
Cervical range of motion exercises in flexion, extension, rotation, and side bending (gentle, controlled movements). Chin tuck exercises in supine or sitting positions to activate deep cervical flexors. Isometric neck strengthening exercises (flexion, extension, lateral flexion), focusing on controlled, static holds. Occulomotor Exercises: Smooth pursuit exercises, where the eyes follow a moving target horizontally, vertically, and diagonally while keeping the head still. Saccadic eye movements, involving quick shifts of gaze between two stationary targets. Gaze stability (VOR x1 and VOR x2) exercises, involving head movements while maintaining focus on a target, and moving the head in opposite direction Otago exercises Strengthening exercises (e.g., knee extensions, hip abduction, calf raises). Static and dynamic balance exercises (e.g., tandem stance, backward walking, sit-to-stand without using hands). A progressive walking plan to improve endurance and confidence during ambulation. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dynamic Balance
Periodo de tiempo: 6 weeks
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Berg Balance Scale (BBS) was used Cut-off Values Greater than 45 → Increased risk of falls 21-40 → Moderate balance impairment Outcome Interpretation Higher score = Better balance
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6 weeks
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Functional Mobility
Periodo de tiempo: 6 weeks
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The Timed Up and Go Test (TUG) was used Cut-off Values: less than 10 seconds → Normal mobility 10-19 seconds → Good mobility 20-29 seconds → Mild impairment
Interpretation: Lower time indicates better performance |
6 weeks
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Dynamic Balance
Periodo de tiempo: 6 weeks
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Four Square Step Test was used to evaluate dynamic balance Cut-off Values: < 15 seconds → Normal performance > 15 seconds → Increased risk of falls Interpretation: Lower time indicates better balance |
6 weeks
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Dizziness related disability
Periodo de tiempo: 6 weeks
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4. Dizziness Handicap was used Cut-off Values: 0-30 → Mild handicap (used in inclusion criteria) 31-60 → Moderate handicap 61-100 → Severe handicap Interpretation: Higher score indicates greater dizziness-related disability |
6 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FUI/FUCP/CTR/Neuro/AmnaMalik
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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