An interventional study of Manual therapy in Developmental Dysplasia of the Hip (DDH) and Congenital Hip Dysplasia, sponsored by Université de Sherbrooke. Not yet recruiting. Open to participants aged 1 Month to 5 Months. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
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.
This is an exploratory randomized pilot study with two parallel groups and baseline and post-intervention assessment of the primary outcome. Thirty infants are planned, with 15 participants per group. Allocation will use stratified randomization by sex and age with variable block sizes. The randomization sequence will be generated before recruitment by an independent person who is not involved in delivering the manual intervention. At T0, all infants will undergo the standard ultrasound assessment used in their orthopedic follow-up, together with collection of baseline clinical and demographic information. Infants assigned to the experimental group will receive the manual intervention in addition to conventional orthopedic treatment, once weekly for three consecutive weeks. Infants assigned to the comparison group will receive conventional orthopedic treatment alone. Adherence to Pavlik harness treatment will be documented in both groups. A final ultrasound 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, both dysplastic hips will be evaluated at T0 and T1 and recorded separately. The manual intervention will be delivered in a standardized manner by one osteopath who is also a physiotherapist and has 25 years of clinical experience, primarily with infants. With the infant in the supine position, manual contacts are placed on the ilium, pubis, and ischium. A gentle, progressive, convergent mechanical stress is directed toward the acetabular cavity. The mechanical stress is maintained for 1 minute and repeated 15 times with 30-second intervals. The session will be stopped immediately if the infant shows significant discomfort, distress, or intolerance. The primary outcome is the change in ultrasound-measured femoral head coverage from T0 to T1. Parental acceptability will be assessed using a study questionnaire informed by the Theoretical Framework of Acceptability and 5-point Likert-scale items. Feasibility measures will include recruitment, completion of intervention sessions, adherence to conventional orthopedic treatment, and tolerability.
60 studies on the registry are indexed under Developmental Dysplasia of the Hip; 18 are open to participants now.
This study's planned enrollment of 30 is below the median of 59 across 38 interventional studies indexed under Developmental Dysplasia of the Hip.
Browse Developmental Dysplasia of the Hip studies →Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, in addition to the Pavlik harness.
Other: Manual therapy
Conventional orthopedic treatment (Pavlik harness) only, following standard pediatric orthopedic care, without the manual 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
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
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
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
No study locations are listed for this record.
Plan to share: Undecided — Decision has not been made yet about this pilot study
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Sep 2027, 13 months later.
Of 20 interventional studies with no phase under Developmental Dysplasia of the Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 13 months is below that.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Developmental Dysplasia of the Hip →