- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Riyadh Region
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Al Kharj, Riyadh Region, Saudi Arabia
- Ragab K. Elnaggar
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Participants in this group received the standard exercise program.
|
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.
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 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".
|
1 month
|
|
Muscle Strength
Time Frame: 1 month
|
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Disability
Time Frame: 1 month
|
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.
|
1 month
|
|
Quality of life (QoL)
Time Frame: 1 Month
|
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.
|
1 Month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/0023/0019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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