Manual Intervention and Congenital Hip Dysplasia in Infants

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is an exploratory randomized pilot study with two parallel groups and baseline andpost‐intervention assessment of the primary outcome. Thirty infants are planned, with 15participants per group. Allocation will use stratified randomization by sex and age withvariable block sizes. The randomization sequence will be generated before recruitment byan independent person who is not involved in delivering the manual intervention. At T0,all infants will undergo the standard ultrasound assessment used in their orthopedicfollow‐up, together with collection of baseline clinical and demographic information.Infants assigned to the experimental group will receive the manual intervention inaddition to conventional orthopedic treatment, once weekly for three consecutive weeks.Infants assigned to the comparison group will receive conventional orthopedic treatmentalone. Adherence to Pavlik harness treatment will be documented in both groups. A finalultrasound assessment will be performed at T1 using the same clinical approach as at T0.For unilateral DDH, the dysplastic hip will be evaluated. For bilateral DDH, bothdysplastic hips will be evaluated at T0 and T1 and recorded separately. The manualintervention will be delivered in a standardized manner by one osteopath who is also aphysiotherapist and has 25 years of clinical experience, primarily with infants. With theinfant in the supine position, manual contacts are placed on the ilium, pubis, andischium. A gentle, progressive, convergent mechanical stress is directed toward theacetabular cavity. The mechanical stress is maintained for 1 minute and repeated 15 timeswith 30‐second intervals. The session will be stopped immediately if the infant showssignificant discomfort, distress, or intolerance. The primary outcome is the change inultrasound‐measured femoral head coverage from T0 to T1. Parental acceptability will beassessed using a study questionnaire informed by the Theoretical Framework ofAcceptability and 5‐point Likert‐scale items. Feasibility measures will includerecruitment, completion of intervention sessions, adherence to conventional orthopedictreatment, and tolerability.
Epistemonikos ID: c709a3f291cbe9f759b62c16322e8153f663352b
First added on: Aug 12, 2026