- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07679464
Aquatic Plyometrics for Adolescents With Patellofemoral Pain Syndrome
Hydro-Kinetic Plyometrics: A Randomized Clinical Assessment of Its Therapeutic Benefits for Adolescents With Patellofemoral Pain Syndrome
Přehled studie
Postavení
Podmínky
Detailní popis
Fifty-six adolescents diagnosed with PFPS were recruited from three major tertiary-care hospitals in Riyadh, Saudi Arabia. Inclusion criteria comprised individuals aged 10 to 18 years with a confirmed PFPS diagnosis (ICD-10 code: M22.2X9). Participants were required to present with chronic pain (>3 months in duration) scoring greater than 3 on a 0-to-10 numeric pain scale, which was exacerbated by physical activity and alleviated by rest. Exclusion criteria encompassed a history of knee surgery, acute knee trauma, patellar subluxation or dislocation, and the use of corticosteroids or anti-inflammatory medications within the preceding six months.
Outcome Measures
Pain Intensity: Assessed during both rest and physical movement using the 11-point Numerical Pain Rating Scale (NPRS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable."
Muscle Strength: Measured as peak concentric torque (in Newton-meters [Nm]) of the quadriceps and hamstring muscle groups using an isokinetic dynamometer at an angular velocity of 120°/sec and 180°/sec.
Functional Disability: Evaluated using the Patellofemoral Disability Index (PDI), a self-reported questionnaire that measures the degree of functional limitation and difficulty an adolescent experiences when performing daily activities due to knee pain.
Quality of Life (QoL): Assessed using the Arabic version of the MOS 36-Item Short Form Health Survey (SF-36), a standardized patient-reported survey that evaluates physical and mental health components across eight health domains.
Interventions
The HK-Polyo group underwent a structured HK-Plyo program conducted in a water medium (pool). The intervention consisted of 24 total sessions, delivered twice a week for 12 consecutive weeks. Each 45-minute session included a 10-minute aquatic warm-up, a 30-minute core plyometric phase, and a 5-minute cool-down. The core phase consisted of 10 unilateral and bilateral lower-limb plyometric exercises, including variations of hopping, bounding, and jumping. Exercise prescription, progression, and safety parameters strictly adhered to the National Strength and Conditioning Association (NSCA) guidelines and the American Academy of Pediatrics (AAP) safety standards.
The control group underwent a standard, land-based exercise program. The intervention consisted of 24 total sessions, delivered twice a week for 12 consecutive weeks, with each session lasting 45 minutes. The program was multimodal and consisted of lower-limb flexibility exercises, progressive lower-extremity strength training, weight-bearing exercises, proprioceptive training, and balance exercises.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Riyadh Region
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Al Kharj, Riyadh Region, Saudská arábie
- Ragab K. Elnaggar
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age of 10-18 years
- Verified diagnosis of PFPS based on the ICD classification system (ICD-10 code for PFPS: M22.2X9)
- Pain more than 3 on (0-10 pain scale).
- Persistent pain more than 3 months
- Pain get worse with activities and get better with rest.
Exclusion Criteria:
- History of knee surgery
- Recent trauma
- Corticosteroids or anti-inflammatory medications in the past 6 months
- Patellar subluxation or dislocation
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Kontrolní skupina
Účastníci této skupiny dostali standardní cvičební program.
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Participants underwent a standard, land-based exercise program.
The intervention consisted of 24 total sessions, delivered twice a week for 12 consecutive weeks, with each session lasting 45 minutes.
The program was multimodal and consisted of lower-limb flexibility exercises, progressive lower-extremity strength training, weight-bearing exercises, proprioceptive training, and balance exercises.
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Experimentální: HK-Plyo group
Participants in this group underwent a structured HK-Plyo program.
|
Participants underwent a structured HK-Plyo program conducted in a water medium (pool).
The intervention consisted of 24 total sessions, delivered twice a week for 12 consecutive weeks.
Each 45-minute session included a 10-minute aquatic warm-up, a 30-minute core plyometric phase, and a 5-minute cool-down.
The core phase consisted of 10 unilateral and bilateral lower-limb plyometric exercises, including variations of hopping, bounding, and jumping.
Exercise prescription, progression, and safety parameters strictly adhered to the National Strength and Conditioning Association (NSCA) guidelines and the American Academy of Pediatrics (AAP) safety standards.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain Intensity
Časové okno: 1 month
|
Assessed during both rest and physical movement using the 11-point Numerical Pain Rating Scale (NPRS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable".
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1 month
|
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Muscle Strength
Časové okno: 1 month
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Measured as peak concentric torque (in Newton-meters [Nm]) of the quadriceps and hamstring muscle groups using an isokinetic dynamometer at an angular velocity of 120°/sec and 180°/sec.
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1 month
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional Disability
Časové okno: 1 month
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Functional disability was assessed using the Patellofemoral Disability Index (PDI), a 10-item, self-administered questionnaire designed to quantify the functional limitations adolescents experience during daily activities secondary to knee pain.
Responses to each item were recorded on a 6-point ordinal scale ranging from 0 to 5. A score of 0 indicated no functional deficit, while a score of 5 signified severe symptom exacerbation or bedbound status.
The intermediate anchors represented a graded spectrum of impairment: 1 (minimal), 2 (minimal-to-moderate), 3 (moderate), and 4 (severe).
Individual item scores were summated to generate a total index ranging from 0 to a maximum of 50 points, wherein higher scores denoted progressively greater levels of disability.
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1 month
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Quality of life (QoL)
Časové okno: 1 Month
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Assessed using the Arabic version of the MOS 36-Item Short Form Health Survey (SF-36), a patient-reported instrument consisting of 36 items that evaluate physical and mental health across eight distinct domains.
Item-level responses were captured using varying Likert scales, which were subsequently coded and mathematically transformed according to standard SF-36 scoring algorithms.
This transformation yielded a standardized score ranging from 0 to a maximum of 100 points for each domain.
In this scoring metric, higher scores denoted a more favorable quality of life, whereas lower scores indicated poorer health status.
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1 Month
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další identifikační čísla studie
- RHPT/0023/0019
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