Developmental Dysplasia of the Hip (DDH)NCT07756814
Manual Intervention and Congenital Hip Dysplasia in Infants
A study testing Manual therapy in people with Developmental Dysplasia of the Hip (DDH) and Congenital Hip Dysplasia, run by Université de Sherbrooke.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 5 months
- Conditions the study is for
- Developmental Dysplasia of the Hip (DDH), Congenital Hip Dysplasia
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
- Parental availability for the study follow-up
Who cannot join
- 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
- Prematurity (birth before 37 weeks of gestation)
- Medical contraindications to the proposed manual intervention
Show all 10Show fewer
- Ongoing physiotherapy or any manual therapy treatment outside the study framework
- Growth retardation (staturo-ponderal), with or without suspected nutritional deficiencies
- Infant showing distress or intolerance to physical handling during prior care
- Simultaneous participation in another clinical study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploring a Manual Intervention on the Coxal Bone in Infants With Congenital Hip Dysplasia: A Pilot Study
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.
Read the detailed description
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.
- Being tested
- Manual therapy
- Keywords
- Developmental dysplasia of the hip, Pilot study, manual therapy, coxal bone, infant
- Medical subject headings
- Developmental Dysplasia of the Hip, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Manual intervention plus conventional orthopedic treatment | Experimental | 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. Receives: Other: Manual therapy |
| Comparison: Conventional orthopedic treatment only | No intervention | Conventional orthopedic treatment (Pavlik harness) only, following standard pediatric orthopedic care, without the manual intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrolment to end of treatment represent about 4 weeks for each participant
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (T0) to final assessment (T1) about 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the Hip (DDH)Studies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chantal Morin, Université de Sherbrooke
- Investigators
- Chantal Morin, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756814
- Sponsor's protocol ID
- DCHbb
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision has not been made yet about this pilot study
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring a Manual Intervention on the Coxal Bone in Infants With Congenital Hip Dysplasia: A Pilot Study
- ClinicalTrials.gov ID
- NCT07756814
- Acronym / sponsor ID
- DCHbb
- Keywords
- Developmental dysplasia of the hip, Pilot study, manual therapy, coxal bone, infant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual intervention plus conventional orthopedic treatment | Experimental | Other: Manual therapyA 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. |
| Comparison: Conventional orthopedic treatment only | No intervention | –Conventional orthopedic treatment (Pavlik harness) only, following standard pediatric orthopedic care, without the manual intervention. |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
- Parental availability for the study follow-up
Key exclusion criteria (10 listed)
- 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
- Prematurity (birth before 37 weeks of gestation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapyA 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 | Other | Manual intervention plus conventional orthopedic treatment |
Primary outcome
Coverage of the femoral head/epiphysis by the acetabulum
Time frame: From enrolment to end of treatment represent about 4 weeks for each participant
Change from T0 to T1 in the ultrasound-measured coverage of the femoral head/epiphysis by the acetabulum in the dysplastic hip
2 secondary outcomes
Parental acceptability of the manual intervention
Time frame: From enrolment to the end of treatment about 4 weeks
Adherence to conventional orthopedic treatment
Time frame: Baseline (T0) to final assessment (T1) about 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided. Decision has not been made yet about this pilot study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chantal Morin, PhD principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Developmental Dysplasia of the Hip (DDH) and Congenital Hip Dysplasia, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Brassard, Master student (1-514-961-6442, sebastien.brassart@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coverage of the femoral head/epiphysis by the acetabulum (time frame: From enrolment to end of treatment represent about 4 weeks for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.