Patellofemoral Pain SyndromeNCT07679464
Aquatic Plyometrics for Adolescents With Patellofemoral Pain Syndrome
A study testing Hydro-Kinetic Plyometric Exercise Program and Standard Exercise Program (Conventional Physical Therapy) in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study was designed to assess the effect of a 12-week hydro-kinetic plyometric (HK-Plyo) training on pain, muscle strength, disability, and quality of life (QoL) in adolescents with patellofemoral pain syndrome (PFPS). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Hydro-Kinetic Plyometric Exercise Program and Standard Exercise Program (Conventional Physical Therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 4 Jun 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- History of knee surgery
- Recent trauma
- Corticosteroids or anti-inflammatory medications in the past 6 months
- Patellar subluxation or dislocation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydro-Kinetic Plyometrics: A Randomized Clinical Assessment of Its Therapeutic Benefits for Adolescents With Patellofemoral Pain Syndrome
This study was designed to assess the effect of a 12-week hydro-kinetic plyometric (HK-Plyo) training on pain, muscle strength, disability, and quality of life (QoL) in adolescents with patellofemoral pain syndrome (PFPS). Fifty-six adolescents with PFPS were randomly allocated to the HK-Plyo group (n = 28, received the plyometric-based hydro-kinetic therapy program, twice/week, over 12 weeks) or the control group (n = 28, received standard exercise program). Both groups were assessed for pain, muscle strength, disability, and QoL pre and post-treatment.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Hydro-Kinetic Plyometric Exercise Program, Standard Exercise Program (Conventional Physical Therapy)
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydro-Kinetic Plyometric Exercise ProgramOther
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.
Standard Exercise Program (Conventional Physical Therapy)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| HK-Plyo group | Experimental | Participants in this group underwent a structured HK-Plyo program. Receives: Other: Hydro-Kinetic Plyometric Exercise Program |
| Control group | Active comparator | Participants in this group received the standard exercise program. Receives: Other: Standard Exercise Program (Conventional Physical Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 1 month
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.
Measured: 1 month
Secondary outcomes (2)
Functional Disability
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.
Measured: 1 month
Quality of life (QoL)
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.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start4 Jun 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, dual-arm, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679464
- Sponsor's protocol ID
- RHPT/0023/0019
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers in order to strictly protect the privacy and confidentiality of the adolescent participants involved in this study
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydro-Kinetic Plyometrics: A Randomized Clinical Assessment of Its Therapeutic Benefits for Adolescents With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT07679464
- Acronym / sponsor ID
- RHPT/0023/0019
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Study start
- 4 Jun 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to assess the effect of a 12-week hydro-kinetic plyometric (HK-Plyo) training on pain, muscle strength, disability, and quality of life (QoL) in adolescents with patellofemoral pain syndrome (PFPS). Fifty-six adolescents with PFPS were randomly allocated to the HK-Plyo group (n = 28, received the plyometric-based hydro-kinetic therapy program, twice/week, over 12 weeks) or the control group (n = 28, received standard exercise program). Both groups were assessed for pain, muscle strength, disability, and QoL pre and post-treatment.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, dual-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HK-Plyo group | Experimental | Other: Hydro-Kinetic Plyometric Exercise ProgramParticipants in this group underwent a structured HK-Plyo program. |
| Control group | Active comparator | Other: Standard Exercise Program (Conventional Physical Therapy)Participants in this group received the standard exercise program. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- History of knee surgery
- Recent trauma
- Corticosteroids or anti-inflammatory medications in the past 6 months
- Patellar subluxation or dislocation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydro-Kinetic Plyometric Exercise ProgramParticipants 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. | Other | HK-Plyo group |
| Standard Exercise Program (Conventional Physical Therapy)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. | Other | Control group |
Primary outcome
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".
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.
2 secondary outcomes
Functional Disability
Time frame: 1 month
Quality of life (QoL)
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers in order to strictly protect the privacy and confidentiality of the adolescent participants involved in this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydro-Kinetic Plyometric Exercise Program and Standard Exercise Program (Conventional Physical Therapy) in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.