- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Afifa Khizar, MSPT
- Telefonní číslo: +923359077922
- E-mail: afifa.khizar15@gmail.com
Studijní záloha kontaktů
- Jméno: Aroona Sattar
- Telefonní číslo: +923054630138
- E-mail: aroona.sattar@ubas.edu.pk
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- NUR FMH System
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Kontakt:
- Muhammad Shahzad, MSPT
- Telefonní číslo: +923028350237
- E-mail: muhammad.shahzad.qadree@niu.edu.pk
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Kontakt:
- Hira Nadeem, MSPT
- Telefonní číslo: +923094229283
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: (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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Aktivní komparátor: (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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Kujala Anterior knee pain scale (AKPS)
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Q angle
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Shoaib Waqas, PHD PT, Lahore University of Biological and Applied Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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