An interventional study of Assigned Interventions in Melorheostosis, sponsored by Yeditepe University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Yeditepe University · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the effects of a structured physiotherapy and rehabilitation-based exercise program on clinical and functional parameters in a patient diagnosed with melorheostosis.
This study specifically aims to assess the effects of a structured physiotherapy and rehabilitation-based intervention program, including patient education and therapeutic exercise, on lower extremity functional parameters, muscle strength, balance, and quality of life in a patient with melorheostosis.
The main hypotheses:
H0: A structured physiotherapy and rehabilitation-based exercise program has no effect on improvement in clinical and functional evaluation parameters in a patient with melorheostosis.
H1: A structured physiotherapy and rehabilitation-based exercise program leads to improvement in clinical and functional evaluation parameters in a patient with melorheostosis.
Melorheostosis is a rare, chronic, and progressive sclerosing bone disorder characterized by cortical bone thickening, pain, joint stiffness, restricted mobility, and functional impairment. Due to its low prevalence, the available literature is limited, and conservative management strategies, particularly physiotherapy interventions, remain insufficiently defined.
A patient diagnosed with melorheostosis who meets the inclusion criteria and is followed by an orthopedic specialist will be included in this prospective single-case study to investigate the effectiveness of a structured physiotherapy and rehabilitation-based exercise program.
The patient, who is under regular physician supervision and willing to participate in the rehabilitation program, will be included in the study. The intervention approach will be based on a non-invasive, exercise-oriented physiotherapy program.
The rehabilitation program will consist of patient education, diaphragmatic breathing training, and a structured exercise program including strength, flexibility, and balance components. The patient will participate in a total of 24 physiotherapy sessions, three days per week, for eight weeks.
Before starting the treatment program, the patient's sociodemographic characteristics, medical history, and disease-related clinical features will be recorded using a structured evaluation form. A baseline clinical evaluation will be performed prior to the intervention.
Following the baseline assessment, the individualized physiotherapy program will be implemented. Exercise intensity and progression will be adjusted according to the patient's pain level and functional capacity throughout the intervention period.
Clinical and functional parameters will be evaluated before the treatment, immediately after the 8-week intervention, and at a 6-month follow-up to assess both short-term and long-term effects.
Throughout the study, the patient will continue routine medical treatment and remain under physician supervision, and no changes will be made to the existing medical management.
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Exclusion Criteria:
The target population of the study consists of a 24-year-old female case diagnosed with melorheostosis by a relevant physician, who voluntarily meets the inclusion criteria. The study is designed as a single-case report and aims to evaluate the clinical and functional characteristics of the case. The participant is actively working as a physiotherapist in her professional life. Patient will receive patient education in addition to a structured exercise program. The exercise program will include progressive strengthening, flexibility, and balance-based exercises. Patient education will be delivered by targeting topics that encompass all components of the ICF framework. In addition, diaphragmatic breathing will be taught to patients prior to the exercise program.
Other: Assigned Interventions
Patient will receive patient education in addition to a structured exercise program. The exercise program will include progressive strengthening, flexibility, and balance-based exercises. Patient education will be delivered by targeting topics that encompass all components of the ICF framework. In addition, diaphragmatic breathing will be taught to patients prior to the exercise program. The exercise program will be conducted three times per week for 8 weeks. Baseline assessments will be performed before the intervention, and post-intervention assessments will be repeated after completion of the program. Furthermore, evaluations will be conducted again during a 6-month follow-up period.
Pain Assessment
The Visual Analog Scale (VAS) was used to evaluate pain intensity. The location and severity of the pain will be questioned. The individual's resting, activity, and nighttime pain levels were evaluated on a 10 cm horizontal line with the extremes of "0: no pain" and "10: unbearable pain". Higher values indicate severe pain. In this study, it is planned to be used to evaluate the pain intensity of the case.
Time frame: Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Month 6)
SF-12 Quality of Life Scale
The SF-12 is a self-reported questionnaire used to assess health-related quality of life. It evaluates both physical and mental health components, yielding two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, where higher scores indicate a better level of health and a higher quality of life.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Passive Knee Extension (PKE) Test
The PKE test is used to assess hamstring muscle flexibility. The participant is positioned supine, with the non-tested limb stabilized and the tested hip fixed at 90 degrees of flexion. As the knee is extended, the angle between the tibia and the vertical vector is measured using an inclinometer placed 15 cm distal to the tibial tuberosity. The measurement is recorded in degrees (°). A smaller angle relative to the vertical line indicates greater knee extension and better hamstring flexibility.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Ankle Active Range of Motion
Ankle AROM (dorsiflexion, plantarflexion, inversion, and eversion) is evaluated using a goniometer in standard anatomical positions. For dorsiflexion and plantarflexion, the participant is seated with knees slightly flexed; the axis of the goniometer is placed over the lateral malleolus, the stationary arm parallel to the fibular line, and the moving arm parallel to the lateral aspect of the 5th metatarsal. For inversion and eversion, the participant sits with legs hanging off the edge of the table; the axis is placed at the midpoint between the two malleoli, the stationary arm on the anterior surface of the tibia, and the moving arm parallel to the longitudinal axis of the 2nd metatarsal. All measurements are recorded in degrees (°), with higher values indicating a greater active range of motion.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Quadriceps Flexibility / Ely's Test
The Ely's test is used to assess the flexibility of the rectus femoris muscle. With the participant in a prone position and the pelvis stabilized, the examiner passively flexes the knee to its maximal limit just before compensatory pelvic flexion occurs. The maximum knee flexion angle is measured using a goniometer and recorded in degrees (°). A higher degree of knee flexion indicates greater quadriceps flexibility.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Gastrocnemius-Soleus Muscle Flexibility Tests
Flexibility of the calf muscles is assessed by measuring ankle dorsiflexion range of motion using a goniometer in standing positions. For the gastrocnemius, the participant stands facing a wall, keeps the tested knee fully extended, and shifts weight forward. For the soleus, the participant assumes a weight-bearing lunge position with the tested knee flexed, keeping both heels firmly on the floor. Measurements are recorded in degrees (°), with higher values representing greater muscle flexibility.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Weight-Bearing Lunge Test - WBLT
The WBLT evaluates closed kinetic chain ankle dorsiflexion under a loaded, functional condition. The participant performs a maximal forward lunge toward a wall, maintaining heel contact with the floor. The angle between the tibia and the vertical axis is measured using a digital inclinometer placed 15 cm distal to the tibial tuberosity. The measurement is recorded in degrees (°). Higher angle values indicate greater dorsiflexion mobility.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Quadriceps Muscle Strength Measurement
Quadriceps strength is evaluated using a digital handheld myometer (dynamometer). The participant is seated with legs hanging from the edge of the table, with both hip and knee positioned at 90 degrees of flexion. The myometer is placed on the anterior surface of the tibia, approximately 5 cm proximal to the lateral malleolus. The participant performs a maximal isometric knee extension for 5 seconds. The peak force is recorded. Higher values indicate greater quadriceps muscle strength.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Hamstring Muscle Strength Measurement
Hamstring strength is evaluated using a digital handheld myometer (dynamometer). The participant is in a prone position, and the tested knee is passively brought to an angle of 30° to 45° of flexion. The myometer is placed on the posterior surface of the tibia, just proximal to the heel (calcaneus). The peak force is recorded. Higher values indicate greater hamstring muscle strength.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Hip External Rotator Muscle Strength Measurement
Hip external rotator strength is evaluated using a digital handheld myometer. The participant is assessed in a side-lying position with the knees flexed at 90 degrees. The myometer is placed on the medial aspect of the leg, just proximal to the medial malleolus of the tested limb. The peak force is recorded. Higher values indicate greater hip external rotator muscle strength.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Y-Balance Test
The Y-Balance Test evaluates dynamic balance. The participant stands on one leg and reaches as far as possible with the contralateral leg in three directions: anterior, posteromedial, and posterolateral. To standardize the measurements, the reach distances are normalized to the participant's lower limb length, measured from the anterior superior iliac spine (ASIS) to the medial malleolus. Higher normalized composite scores indicate better dynamic balance and stability.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Feiss Line Test
The Feiss Line Test evaluates the height of the medial longitudinal arch and static foot posture. While the participant is seated (non-weight bearing) and then standing, the medial malleolus, navicular tubercle, and the center of the first metatarsophalangeal (MTP) joint are marked. An imaginary line (Feiss Line) is drawn between the medial malleolus and the first MTP joint. The position of the navicular tubercle relative to this line is examined to grade the arch height.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Navicular Drop Test
The Navicular Drop Test assesses excessive foot pronation and the dynamic stability of the medial longitudinal arch under load. With the participant seated (non-weight bearing) and the subtalar joint in a neutral position, the height of the navicular tubercle from the floor is measured in millimeters. The participant then stands with weight distributed evenly on both feet (weight-bearing position), and the measurement is repeated. The difference between the two measurements is recorded as the navicular drop (in mm). A higher drop value indicates greater dynamic foot pronation and reduced arch stability.
Time frame: Baseline (Week 0), Week 8, and Month 6.
Plan to share: No — Individual participant data (IPD) will not be shared to protect the privacy of the single participant involved in this case report.
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Melorheostosis
Yeditepe University