Manual Intervention and Congenital Hip Dysplasia in Infants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversité de Sherbrooke

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Manual therapy

    Other intervention

    A 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

30 Participants
are divided into 2 treatment groups
Group A: Manual intervention plus conventional orthopedic treatmentExperimental treatment 1 intervention
Group B: Comparison: Conventional orthopedic treatment onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From enrolment to end of treatment represent about 4 weeks for each participant

Secondary outcomes

1

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.

Time frame
From enrolment to the end of treatment about 4 weeks
2

Adherence to conventional orthopedic treatment

Documented in both groups using parental reports of Pavlik harness wearing time, removals, difficulties, and recommendations received.

Time frame
Baseline (T0) to final assessment (T1) about 4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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