- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07703072
Effect of Short Foot Exercise Combined With Focused Hip and Knee Exercises on Pain, Q Angle and Functional Outcomes in Female Patients With Patellofemoral Pain Syndrome
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patellofemoral Pain Syndrome (PFPS) is a common musculoskeletal condition characterized by anterior knee pain, particularly prevalent among females due to anatomical and biomechanical factors. Although conventional rehabilitation focuses on hip and quadriceps strengthening, persistent symptoms suggest the involvement of distal biomechanical contributors such as foot pronation and intrinsic foot muscle weakness.
Short Foot Exercise (SFE) targets intrinsic foot musculature, improves medial longitudinal arch stability, and enhances neuromuscular control. This study investigates whether combining SFE with hip and knee strengthening provides superior outcomes compared to conventional rehabilitation alone.
This study is a two-arm parallel randomized controlled trial including 38 female participants aged 18-45 years diagnosed with PFPS. Participants will be randomly allocated into experimental and control groups using a computer-generated sequence with allocation concealment. The intervention will be conducted over 6 weeks, with three supervised sessions per week.
The experimental group will receive short foot exercises along with hip and knee strengthening, while the control group will receive hip and knee strengthening only. Outcome measures including pain (VAS), functional status (Kujala AKPS), and Q-angle will be assessed at baseline and post-intervention.
The study aims to determine whether a combined proximal-distal rehabilitation approach leads to better improvements in pain, alignment, and functional outcomes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Afifa Khizar, MSPT
- Número de teléfono: +923359077922
- Correo electrónico: afifa.khizar15@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Aroona Sattar
- Número de teléfono: +923054630138
- Correo electrónico: aroona.sattar@ubas.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- NUR FMH System
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Contacto:
- Muhammad Shahzad, MSPT
- Número de teléfono: +923028350237
- Correo electrónico: muhammad.shahzad.qadree@niu.edu.pk
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Contacto:
- Hira Nadeem, MSPT
- Número de teléfono: +923094229283
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Diagnosed cases of patellofemoral pain syndrome confirmed by this protocol.
- Females aged 18-45 years
- Anterior or retro patellar knee pain lasting ≥ 6 weeks
Pain provoked by at least one PFJ-loading task, including:
- squatting,
- stair climbing/descending,
- running,
- prolonged sitting with knees flexed
Pain elicited by at least two of four clinical tests;
- Pain during isometric quadriceps contraction at 20-30° knee flexion
- Pain on palpation of the patellofemoral joint line
- Pain during patellar compression
- Pain during active resisted knee extension
Exclusion Criteria:
History of patellar instability, including subluxation or dislocation 2. Evidence of tibiofemoral pathology, such as: Ligamentous injuries, meniscal tears, and symptomatic knee effusion.
3. Previous knee surgery within the last 12 months 4. Radiographic or clinical knee osteoarthritis. 5. Neurological disorders or systemic inflammatory diseases that may influence gait or pain perception.
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: (Short Foot + Hip and Knee Exercises)
Participants in this group will receive a combined rehabilitation program consisting of short foot exercises (SFE) along with focused hip and knee strengthening exercises.
The intervention aims to address both distal (foot) and proximal (hip and knee) biomechanical factors contributing to patellofemoral pain syndrome.
The program will be supervised, conducted three times per week for 6 weeks, with progressive advancement from non-weight-bearing to functional weight-bearing activities.
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Short Foot Exercises (SFE) Structured intrinsic foot muscle training involving medial longitudinal arch elevation without toe flexion, progressing from seated to standing and functional positions. Hip and Knee Strengthening Exercises Progressive strengthening program targeting hip abductors, external rotators, and quadriceps muscles through functional and resistance-based exercises. |
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Comparador activo: (Hip and Knee Exercises Only)
Participants in this group will receive a conventional rehabilitation program consisting of focused hip and knee strengthening exercises only.
This program targets proximal muscle groups responsible for patellofemoral joint stability and function.
The intervention will be supervised, conducted three times per week for 6 weeks, and matched in duration and intensity to the experimental group.
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Hip and Knee Strengthening Exercises alone Progressive strengthening program focusing on hip abductors, external rotators, and quadriceps muscles, including both non-weight-bearing and functional weight-bearing exercises.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Kujala Anterior knee pain scale (AKPS)
Periodo de tiempo: Baseline measurement and after 6 weeks intervention
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The Kujala AKPS is a 13-item questionnaire specifically designed to evaluate symptoms and functional limitations associated with patellofemoral disorders.
It assesses domains such as limping, walking, running, stair climbing, squatting, sitting, swelling, and pain.
Total scores range from 0 to 100.
Scores ranging 90-100 indicating better knee function while score range from 0-50 shows significant pain and functional impairment.
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Baseline measurement and after 6 weeks intervention
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Visual Analogue Scale
Periodo de tiempo: Baseline measurement and after 6 weeks intervention
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The Visual Analogue Scale is a 10-cm line used to assess the intensity of pain.
Participants mark a point on the line that represents their current level of pain, ranging from 0 = no pain to 10 = worst possible pain.
The distance in centimeters is measured to quantify pain severity.
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Baseline measurement and after 6 weeks intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Q angle
Periodo de tiempo: Baseline measurement and after 6 weeks intervention
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The Q-angle represents the quadriceps pull angle, measured using a universal goniometer by aligning landmarks at the anterior superior iliac spine (ASIS), center of patella, and tibial tuberosity.
Patient lies in a supine relaxed position with knee extended.
Fulcrum of goniometer is placed directly over the center of patella and stationary arm is aligned with the line connecting ASIS to midpoint of patella while the moving arm is aligned with the line connecting tibial tuberosity to the midpoint of patella.
It provides insight into lower-limb alignment and patellar tracking mechanics.
Normal Q angle measurement in females ranges from 13-19 degrees.
Altered or increased Q-angles have been associated with PFPS and patellar maltracking.
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Baseline measurement and after 6 weeks intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Shoaib Waqas, PHD PT, Lahore University of Biological and Applied Sciences
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UBAS/ERB/26/04/032
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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