NCT07679464

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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".

    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.

    1 month

Secondary Outcomes (2)

  • Functional Disability

    1 month

  • Quality of life (QoL)

    1 Month

Study Arms (2)

HK-Plyo group

EXPERIMENTAL

Participants in this group underwent a structured HK-Plyo program.

Other: Hydro-Kinetic Plyometric Exercise Program

Control group

ACTIVE COMPARATOR

Participants in this group received the standard exercise program.

Other: Standard Exercise Program (Conventional Physical Therapy)

Interventions

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.

HK-Plyo group

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.

Control group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of knee surgery
  • Recent trauma
  • Corticosteroids or anti-inflammatory medications in the past 6 months
  • Patellar subluxation or dislocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, dual-arm, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

June 4, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations