Manual Intervention and Congenital Hip Dysplasia in Infants

NCT07756814 | Not Yet Recruiting

• 1 other identifier: DCHbb
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Developmental Dysplasia of the Hip (DDH); Congenital Hip Dysplasia

Keywords

Developmental dysplasia of the hip; Pilot study; manual therapy; coxal bone; infant

Outcome Measures

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

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

Secondary Outcomes (2)

• Parental acceptability of the manual intervention

  From enrolment to the end of treatment about 4 weeks

• Adherence to conventional orthopedic treatment

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

Study Arms (2)

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.

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.

Interventions

Manual therapy OTHER

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

Manual intervention plus conventional orthopedic treatment

Eligibility Criteria

• Age: 1 Month - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

MeSH Terms

Conditions

Developmental Dysplasia of the Hip; Hip Dislocation, Congenital

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Chantal Morin, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Brassard, Master student

CONTACT

1-514-961-6442; sebastien.brassart@usherbrooke.ca

Chantal Morin, PhD

CONTACT

1-819-821-8000; chantal.morin@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Rehabilitation

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08