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Not yet recruitingNCT06007833Updated Aug 23, 2023

Physical Therapy Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia

An interventional study of Physical Therapy and Rehabilitation Modalities and Conventional Group in Exercise and Developmental Dysplasia of the Hip, sponsored by Inonu University. Not yet recruiting at 1 site in Turkey. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2023-08-23.

Primary conditionDevelopmental Dysplasia of the HipRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Developmental Dysplasia of the Hip
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Developmental Dysplasia of the Hip.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study summary

The aim of this study was to investigate the effects of physical therapy and rehabilitation applications on the hip and defined functional parameters in children with developmental hip dysplasia.

Read the detailed description

Developmental dysplasia of the hip (DDH) is one of the most important factors causing disability in childhood. DDH is the reason for 29% of all primary hip replacements under 60 years of age. The treatment of DDH, which is applied after an average of 12 months of age in infants, becomes difficult due to shortening of the extra-articular soft tissues, acetabular dysplasia, capsular restriction, and increased femoral anteversion. In the treatment of subluxation, dislocation and residual acetabular dysplasia, many pelvic iliac osteotomies are actively applied to increase joint stability and compatibility of the femur acetabulum. The treatment method and physical therapy to be applied in the treatment of DDH vary depending on the age and type of pathology. Therefore, osteotomies can be performed in isolation or in combination with open reduction of the hip and femoral osteotomies. The general opinion about the minimum patient age for iliac osteotomies (Dega osteotomy, Salter innominate) is that it can be done in children who are at walking age. With Dega osteotomy, anterior, lateral and mainly posterior deficiencies are eliminated by changing the acetabular inclination and structure and increasing the grip between the femoral head and the acetabulum.

In the literature, there are studies on the examination of various angular values of the hip (alpha, beta, coverage angle), various classification methods, and whether the postoperative follow-up of children who underwent open, closed reduction and osteotomy requires a reconstructive surgical procedure. No studies have been found on the strength of the hip muscles due to the application of surgical techniques in children with DDH who have weak hip, chorea and lower extremity muscles due to intrauterine and structural conditions. There are no studies on how the affected muscles affect the hip parameters and functional capacities of children with DDH. We think that hip muscle strength, femoral head and anteversion angle, acetabular index, hip adductor muscle tension are important in terms of hip stability and functionality in children aged 2-5 years. Due to the lack of studies in this field in the literature, this study; The aim of this study was to examine the effects of physical therapy and rehabilitation practices on hip and determined functional parameters in children with developmental dysplasia of the hip.

02

Conditions studied

  • Exercise
  • Developmental Dysplasia of the Hip

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Keywords

  • Dysplasia
  • Hip subluxation
  • Dislocation
  • Rehabilitation
03

In context

Developmental Dysplasia of the Hip Reclassified

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 →

Lead sponsor

Inonu University is the lead sponsor of 394 studies on the registry; 95 are open to participants now.

Compared within Developmental Dysplasia of the Hip, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 2-5 years old,
  • Diagnosed with developmental hip dysplasia,
  • Have not undergone any foot surgery,
  • Not having any neurological or rheumatological disease,
  • Having sufficient cooperation to understand and correctly apply the tests,
  • Patients with from their families were included.

Exclusion criteria

Exclusion Criteria:

  • Having neurological problems,
  • Meningomyelocele (diagnosed with Spina Bifida),
  • Mental retardation and uncooperative,
  • Children with inflammation, spasticity, spina bifida, arthrocentesis,
  • Down syndrome-related dislocation,
  • Children who could not obtain from their families were excluded from the study.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    physical therapy and rehabilitation program in addition to conservative treatment

    Orthoses and positioning will be applied to the experimental group as a conservative treatment, following post-surgical plastering. In addition, they will receive a physical therapy and rehabilitation program

    Behavioral: Physical Therapy and Rehabilitation Modalities

  • Active comparator
    Conventional Group

    As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied

    Behavioral: Conventional Group

Interventions

  • BehavioralPhysical Therapy and Rehabilitation Modalities

    In the experimental group, the subjects who were taken to the physical therapy modality in addition to conventional therapy. Total, each session was performed for 60 minutes, 8 weeks, 3 days a week, under the supervision of a physiotherapist, while the other days, the family member performed 3 times a day, each movement for 3 sets, 10-15 repetitions, for a total of 60 minutes. A rest interval of less than 2 minutes was given between each set. By making use of heat modalities before starting the exercises, the elongation ability of the warmed tense structure was increased and the risk of damage in stretching exercises was reduced. The cold application was applied to the soft tissues in the extended position for 1-2 minutes with a cold pack, as the application of cold immediately after the stretching would ensure the preservation of the range of motion. Progress in the exercise program; adjusted for strength, endurance, flexibility, balance and functionality parameters.

  • BehavioralConventional Group

    As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning was applied.

06

What researchers measure

Primary outcomes

  1. The Evaluation of Trunk Control

    Trunk Control Measurement Scale, This scale, which is applied to evaluate trunk control, consists of 2 sub-headings as static sitting balance and dynamic sitting balance. The trunk control measurement scale includes a total of 15 items evaluating trunk control in children. Individuals; without back support, feet are in full contact with the ground, and hips and knees are seated in 90º flexion. In the static sitting balance subgroup (items 1-5), the patient's performance in maintaining trunk stabilization while the upper and lower extremities are in motion is evaluated. It consists of dynamic sitting balance parameters (item 6-15), selective movement control (item 6-12) and dynamic reaching subscale (item 13-15). Functional reach, which is a sub-parameter of dynamic sitting balance, is an important parameter in evaluating balance in children. Scoring of this scale varies between 0-58; A higher score indicates better trunk control.

    Time frame: baseline and week 8

Secondary outcomes

  1. The Evaluation of the Endurance of the Spinal Stability Muscles

    Modified "Biering-Sorensen" trunk extension, trunk flexion test, lateral and prone bridge test are applied to evaluate the static endurance of spinal stability muscles. The number of repetitions completed by the patients within a 30-second test interval is documented; a higher number of repetitions indicate strong performance.

    Time frame: baseline and week 8

  2. The Evaluation of the Strength of the Spinal Stability Muscles

    "Sit-ups" and Modified "Push-ups" tests are applied to evaluate the strength of spinal stability muscles. The number of repetitions that the patients could do for 30 seconds during the test is recorded.

    Time frame: baseline and week 8

  3. The Evaluation with Radiological Imaging of Hip Parameters

    Femoral head ossification in mm, femoral inclination angle in degrees, acetabular index developments in degrees will be examined.

    Time frame: baseline and week 8

  4. The Assessment of Aerobic Capacity

    The 1-min walk test is used to evaluate the walking capacity of a pediatric individual, which is defined as the maximum walking speed.

    Time frame: baseline and week 8

  5. The Evaluation of Anaerobic Capacity

    10m walking test is used to evaluate of anaerobic capacity. The time the child completes the 10-meter course at normal walking speed is recorded.

    Time frame: baseline and week 8

  6. The Evaluation of the Dynamic Balance

    Timed get up and go test, evaluates the dynamic balance of individuals during functional mobility; It includes components such as standing, walking and turning. The children are asked to stand up without support from the chair they are sitting in, and to return from the designated area after walking a 3-meter distance at a normal pace and sit back in the chair without support. After a trial walk, the test is repeated three times; The average of the results is recorded. At the end of the test, the time calculated with the stopwatch is noted in seconds.

    Time frame: baseline and week 8

  7. The Evaluation of Functional Mobility and Dynamic Balance

    It is a simple test applied to evaluate functional mobility and dynamic balance. The child, who is standing at a height of 20 cm by the child's leg length and 30 cm away on a 10-step ladder, is told to go up and down the stairs as quickly and safely as he can.

    Time frame: baseline and week 8

  8. The Evaluation of Muscle Strength

    In muscle strength measurements; hip flexors, abductors, extensors, knee flexors and extensors, foot dorsiflexors and plantar flexors are evaluated. Manual Muscle Testing System (Lafayette Instrument Company, Lafayette, AB) (Lafeyette), an easy-to-carry, easy-to-use, inexpensive and portable handheld dynamometer, is used to measure maximum muscle strength for our measurements.

    Time frame: baseline and week 8

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06007833
Lead sponsor
Inonu University
Responsible party
Elisa Çalışgan (The Investigation of the Effects of Physical Therapy and Rehabilitation Applications on the Hip and Defined Functional Parameters in Children with Developmental Hip Dysplasia, Inonu University) — Principal investigator
First posted
Aug 23, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Oct 30, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
Aug 23, 2023

Study contacts

Elisa Çalışgan, PhD
Contact
elisa.calisgan@inonu.edu.tr
05342462471
Betül Akyol, PhD
Contact
betül.akyol@inonu.edu.tr
05052924448
Elisa Calisgan, PhD
principal investigator · Inonu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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