- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07806929
Comparison Between Foot Segment Mulligan Mobilization and Ilium Mulligan Mobilization in Treatment Patellofemoral Pain Patients With Flatfeet: a Randomized Controlled Comparative Study (PFP)
Targeting the Lower-Limb Kinetic Chain in Patellofemoral Pain: A Randomized Comparison of Foot and Ilium Mulligan Mobilization Combined With Hip-Knee Focused Exercises
Přehled studie
Postavení
Podmínky
Detailní popis
Patellofemoral pain is a common musculoskeletal condition characterized by pain around or behind the patella that is aggravated by activities such as squatting, stair negotiation, running, and prolonged sitting. Although local knee impairments may contribute to symptoms, factors throughout the lower-limb kinetic chain may also influence patellofemoral mechanics and clinical presentation.
Foot pronation may alter lower-limb biomechanics during weight-bearing activities and may contribute to changes in tibial and femoral movement. Proximal factors, including pelvic alignment and dynamic knee valgus, may also influence lower-limb loading and patellofemoral joint mechanics. Exercise therapy targeting the hip and knee is commonly used for the management of patellofemoral pain; however, it may not fully address kinetic-chain impairments in patients presenting with concomitant foot pronation.
This study will evaluate whether adding Mulligan mobilization directed toward either the distal foot segment or the proximal ilium/pelvic segment provides additional clinical and biomechanical benefits when combined with a standardized hip- and knee-focused exercise program.
Participants with patellofemoral pain and clinically relevant foot pronation will be screened according to predefined eligibility criteria and randomly allocated to one of three parallel groups:
Foot Mulligan Mobilization Group: Participants will receive standardized hip- knee focused therapeutic exercises combined with Mulligan mobilization directed toward the foot segment.
Ilium Mulligan Mobilization Group: Participants will receive the same standardized hip- knee focused therapeutic exercises combined with Mulligan mobilization directed toward the ilium/pelvic segment.
Control Group: Participants will receive the standardized hip- knee focused therapeutic exercise program alone.
The intervention period will last 4 weeks. Outcome measures will be assessed at baseline and immediately after completion of the intervention.
The primary outcomes will be pain intensity, assessed using the Visual Analogue Scale (VAS), and functional status, assessed using the Anterior Knee Pain Scale (AKPS). Secondary outcomes will include hip and knee muscle strength assessed using a handheld dynamometer, dynamic knee valgus assessed using photogrammetric analysis and Kinovea motion-analysis software, pelvic tilt angle assessed using a PALM/pelvic inclinometer, and foot posture assessed using the Foot Posture Index (FPI).
The study will primarily examine changes over time and differences among the three treatment groups, with particular attention to the group-by-time interaction. Appropriate statistical analyses will be performed based on the distribution and characteristics of the collected data, with statistical significance set at p < 0.05.
The study aims to determine whether targeting the distal or proximal segment of the lower-limb kinetic chain provides greater additional benefit when combined with hip-knee focused exercises in patients with patellofemoral pain and foot pronation.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Labib M Ghali, PhD
- Telefonní číslo: 002 01201991948
- E-mail: labibmousa7@cu.edu.eg
Studijní záloha kontaktů
- Jméno: Samah H Nagib, PhD
- Telefonní číslo: 00962 776671425
- E-mail: s.nagib@zuj.edu.jo
Studijní místa
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Amman, Jordán, 11733
- Al-Zaytoonah University of Jordan
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Kontakt:
- Samah H Nagib, PhD
- Telefonní číslo: 00962 776671425
- E-mail: s.nagib@zuj.ed.jo
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age of the subjects between 18-35 years
- BMI was from 18.5 to ≤ 29.5 Kg/m² .
- Anterior or retro patellar knee pain for at least 6 weeks duration.
- Foot posture index score from +6 to + 12.
- Sagittal plane innominate tilt angle more than 8 degrees.
- Pain elicited at least by two of the following four screening tests; (i) isometric muscle contraction with slight bent knee,(ii) palpation of the patella, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
- Pain provoked by at least two of the following activities: running, walking, hopping, squatting, stair negotiation, kneeling, or prolonged sitting
Exclusion Criteria:
- Meniscal or other intra-articular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation..
- Previous surgery in the knee, ankle and hip joints.
- Knee, ankle and hip joints osteoarthritis.
- Taking non-steroidal anti-inflammatory drugs or corticosteroids within 24 hours before the test.
- History of brain injury or vestibular disorder within the last 6 months.
- Pregnant female.
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: Group A: Foot segment Milligan mobilization group
mobilization with movement for talonavicular and talocrural joint + Hip-knee focused exercises
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Mobilization with movement of the foot segment First, a dorsal glide of the talonavicular joint will be combined with plantarflexion and inversion of the foot. Second, a posterior glide of the talocrural joint will be applied in combination with the corresponding active ankle dorsiflexion. Both mobilization techniques will be applied for 10 repetitions/ 3 sets
Ostatní jména:
Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle. The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators. The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.
Ostatní jména:
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Experimentální: Group B: Ilium Milligan mobilization group
mobilization with movement of ilium + Hip-knee focused exercises
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Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle. The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators. The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.
Ostatní jména:
the patients will be in prone position with their hands at shoulder level, and the therapist will stand on the opposite side of the mobilized ilium.
The therapist will stabilize the sacrum with the medial aspect of one hand, place the fingers of the other hand under the anterior superior iliac spine, and then will pull the ilium in posterior translation and rotation in relation to the sacrum.
Next, the patient will be asked to perform 10 pain-free press-ups by extending the elbows.
The mobilization included 3 sets with 10 repetitions for each set and a 30-s rest in between.
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Aktivní komparátor: Group C: Control group
Hip-knee focused exercises only
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Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle. The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators. The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Function measured by Anterior Knee Pain Scale
Časové okno: baseline and after 4 weeks
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Anterior Knee Pain Scale (AKPS) It is a self-administered, weighted questionnaire that examines 13 different items including pain and functionality and a maximum score of 100 points, with higher scores indicating better lower extremity function.
It documents response to six activities associated specifically with AKPS (walking, running, jumping, climbing stairs, squatting and sitting for prolonged period with knee bent).
This scale has demonstrated high test-retest reliability and is considered a good and valid detector for significant changes after treatment of patients with PFPS.
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baseline and after 4 weeks
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Pain measured by Numeric pain rating scale (NPRS)
Časové okno: baseline and after 4 weeks
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Numeric pain rating scale (NPRS) The numeric pain rating scale ranges from 0 to 10 points, where 0 represents no pain and 10 represents the worst possible suffering.
Its ICC which measures the reliability of test-retests, has been 0.76, indicating that it is a reliable measure of pain intensity.
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baseline and after 4 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Muscle strength by hand-held dynamometer
Časové okno: baseline and after 4 weeks
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This device is valid and reliable in assessment of muscle strength during the dynamic movement and also during the isometric contraction of the muscles with intra-rater correlation coefficient (ICC ≥0.75). It used to assess the isometric muscle strength of hip and knee joint in patient with PFPS by using a calibrated Nicholas hand-held dynamometer (Lafayette Instrument Company, Lafayette, IN, USA) which characterized by good to excellent interrater and intra-rater reliability |
baseline and after 4 weeks
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Pelvic tilt angle by Palpation Meter device (PALM)
Časové okno: baseline and after 4 weeks
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Palpation meter (PALM) is a pelvic leveling tool that blends inclinometer and caliper functions, it's made by performance Attainment Associates (Performance Attainment Associates, 3600 LaBore, Suite 6, Saint Paul, MN 55110 - 4144 USA).
It's developed to measure pelvic torsion, pelvic tilting and leg length discrepancy (LLD).
The body of the PALM contains a bubble level in a semi-circular arc with one-degree graduations that range from zero degree to thirty degrees on either side of the midline.
The caliper arms are placed in bony landmarks and the degree of deviation from horizontal is read from the inclinometer.
Interclass correlation coefficient suggests that intratester reliability was high for frontal plane measure (0.84) and sagittal plane measures (0.98) and intertester reliability was high for sagittal plane measures (0.89) but moderate for frontal plane measures (0.65).
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baseline and after 4 weeks
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foot pronation by Foot Posture Index (FPI)
Časové okno: baseline and after 4 weeks
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It is a clinical tool that measures foot posture in multiple planes and anatomical segments. Its correlation coefficient showed excellent intra-rater reliability (ICC = 0.89-0.96) which indicates a very good FPI-6 reliability in the foot assessment. The FPI-6 is a valid cheap non-invasive instrument which in a fast and simple way allows one to conduct a comprehensive evaluation of many parameters of the foot's construction without the need to apply complex and time-consuming measurement methods. Foot posture index determined either the foot was pronated or not based on the scores of its six items (talar head palpation curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment). Each of the six items of FPI-6 was evaluated on a scale from -2 to +2. The neutral position of the foot is classified as 0, a positive score is foot pronation and negative score is foot supination |
baseline and after 4 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Labib M Ghali, PhD, Cairo University
- Studijní židle: Samah H Nagib, PhD, Al-Zaytoonah University of Jordan
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
- Talipes
- Nemoci pohybového aparátu
- Onemocnění kloubů
- Muskuloskeletální abnormality
- Vrozené vady
- Deformace dolních končetin, vrozené
- Deformace končetin, vrozené
- Deformace chodidla
- Deformace chodidla, získané
- Deformace chodidla, vrozené
- Vrozené, dědičné a neonatální nemoci a abnormality
- Syndrom patelofemorální bolesti
- Plochá noha
Další identifikační čísla studie
- IRB # 30/8/2025 2026
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