NCT07590128

Brief Summary

This pilot study evaluates the preliminary effectiveness of a combined rehabilitation program incorporating hold-relax (H-R) stretching techniques and progressive therapeutic exercises on knee pain and range of motion (ROM) in adolescent athletes diagnosed with Osgood-Schlatter disease. Utilizing a retrospective, single-group pre-post design on a cohort of six athletic participants, this study aims to generate preliminary clinical evidence and assess feasibility to inform future larger-scale randomized controlled trials. Participants underwent a structured, multi-week rehabilitation protocol, with primary clinical outcomes assessed before and after the intervention period using validated measures of pain intensity and knee joint mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

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

January 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Knee Pain Intensity on the Visual Analog Scale (VAS)

    Knee pain during athletic activity is assessed using a 10-centimeter Visual Analog Scale (VAS). The scale is a horizontal line where 0 centimeters indicates "no pain" and 10 centimeters indicates "the worst possible pain." The outcome is calculated as the change in the pain score (post-intervention score minus baseline score). A negative change indicates an improvement (reduction) in knee pain.

    Baseline (Day 1, pre-intervention) and post-intervention (Week 10, immediately following completion of the last rehabilitation session).

Secondary Outcomes (1)

  • Change from Baseline in Active Knee Flexion Range of Motion

    Baseline (Day 1, pre-intervention) and post-intervention (Week 10, immediately following completion of the last rehabilitation session).

Study Arms (1)

Combined Rehabilitation and Hold-Relax Cohort

ACTIVE COMPARATOR

A single experimental group of adolescent athletes diagnosed with Osgood-Schlatter Disease (OSD). All participants in this cohort receive a structured, multi-week progressive rehabilitation program combined with Hold-Relax (H-R) proprioceptive neuromuscular facilitation (PNF) stretching techniques. The intervention protocol consists of: * Hold-Relax stretching targeting the quadriceps and hamstring muscle groups to reduce tensile stress on the tibial tuberosity. * Progressive therapeutic exercises focusing on lower extremity strengthening, load tolerance, and functional biomechanics.

Behavioral: Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF)Behavioral: Progressive Rehabilitation Program

Interventions

A target-specific, manual stretching technique administered by a physical therapist to address muscular tightness in the lower extremity. The protocol focuses on the bilateral quadriceps and hamstring muscle groups to reduce the cumulative tensile traction forces exerted on the tibial tuberosity. For each target muscle group, the procedure is performed as follows: Passive Stretch: The physical therapist moves the joint to the limit of comfortable range of motion (ROM) where mild muscle tightness is felt. Isometric Contraction: The participant performs an active, sub-maximal isometric contraction (approximately 50% of maximum voluntary contraction) against the therapist's manual resistance for 6 to 10 seconds, ensuring no actual joint movement occurs. Relaxation and Deeper Passive Stretch: The participant is instructed to relax completely, and the therapist immediately moves the limb passively into a newly gained, deeper range of motion, holding the stati

Combined Rehabilitation and Hold-Relax Cohort

A structured, step-by-step active exercise program designed to build lower-limb load tolerance, correct biomechanical compensations, and stabilize the knee joint complex. The rehabilitation progresses systematically through targeted phases based on individual pain levels and movement quality:Phase 1 (Pain Mitigation and Muscle Activation): Focuses on isometric quadriceps setting, straight leg raises (SLR), gluteal bridging, and ankle/hip mobility exercises to avoid direct loading of the patellar tendon while minimizing disuse atrophy.Phase 2 (Strength and Load Tolerance): Introduces closed-kinetic chain exercises with controlled ranges of motion, including shallow wall sits, leg presses, bilateral squats, and progressive calf raises.Phase 3 (Eccentric and Functional Progression): Focuses on eccentric quadriceps strengthening (e.g., controlled step-downs) and sport-specific functional retraining to prepare the adolescent athlete's patellar tendon and tibial tubercle to absorb high groun

Combined Rehabilitation and Hold-Relax Cohort

Eligibility Criteria

Age14 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of Osgood-Schlatter disease
  • Presence of anterior knee pain localized at the tibial tuberosity
  • Regular participation in sports involving running and jumping
  • No participation in structured rehabilitation programs within the previous 3 months

You may not qualify if:

  • History of knee surgery or major trauma
  • Presence of other knee pathologies (e.g., ligament or meniscal injuries)
  • Neurological or systemic disorders affecting movement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batna 2 University

Batna City, Batna, 05078, Algeria

Location

MeSH Terms

Conditions

Osteochondrosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Mahmoud El sayed, Bachelor of Physical Therapy

    Benha University

    PRINCIPAL INVESTIGATOR
  • Ahmed Said, Bachelor of Physical Therapy

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Biochemistry

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 15, 2026

Study Start

January 2, 2026

Primary Completion

March 30, 2026

Study Completion

April 15, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations