About this trial
Developmental dysplasia of the hip (DDH) is a developmental abnormality of the infant hip in which the acetabulum does not adequately cover the femoral head. Standard conservative treatment commonly includes a Pavlik harness. This exploratory randomized pilot study will assess whether a gentle manual intervention applied to the coxal bone, in addition to conventional orthopedic treatment, is associated with a greater change in ultrasound-measured femoral head coverage than conventional orthopedic treatment alone. Thirty infants aged 1 to 5 months with confirmed unilateral or bilateral DDH (Graf IIa to III) will be randomized to two parallel groups. The experimental group will receive one manual intervention session per week for three consecutive weeks in addition to conventional orthopedic treatment. The comparison group will receive conventional orthopedic treatment alone. Ultrasound assessments will be performed at baseline (T0) and after the intervention period (T1). In infants with bilateral DDH, both dysplastic hips will be evaluated at both time points and recorded separately. A secondary objective is to describe parental acceptability of the manual intervention and study procedures. As a pilot study, the project is intended to provide preliminary information on the direction and variability of the intervention effect, parental acceptability, and study feasibility to inform a future larger trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of DDH, unilateral or bilateral
Graf score between IIa and III (moderate to severe DDH), as stage I may resolve spontaneously
Written parental authorization (or delegated parental representation) providing free and informed consent
Infant already receiving conservative orthopedic care with a Pavlik harness (the study tests a complementary intervention)
Disqualifiers
Presence of severe congenital anomalies
Neuromuscular or genetic diseases affecting muscle tone or bone growth
Cardiorespiratory conditions requiring constant monitoring
Fractures of the pelvis or lower limbs
Trial design
Parallel
Treatments tested in this trial
Manual therapy
Other interventionA gentle, convergent mechanical stress is applied toward the acetabulum through the ilium, pubis, and ischium of the coxal bone; held for 1 minute and repeated 15 times with 30-second intervals
Treatment groups
Trial outcomes
Primary outcomes
Coverage of the femoral head/epiphysis by the acetabulum
Change from T0 to T1 in the ultrasound-measured coverage of the femoral head/epiphysis by the acetabulum in the dysplastic hip
Secondary outcomes
Parental acceptability of the manual intervention
Assessed with a questionnaire informed by the Theoretical Framework of Acceptability (TFA) using 5-point Likert scales, covering affective attitude, burden, intervention coherence, perceived effectiveness, perceived safety, ethicality, opportunity cost, and general acceptability. Acceptability of the manual intervention is distinguished from the burden of the research protocol and from conventional orthopedic treatment.
Adherence to conventional orthopedic treatment
Documented in both groups using parental reports of Pavlik harness wearing time, removals, difficulties, and recommendations received.
Locations
Sponsors and contacts
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