ExerciseNCT06007833
Physical Therapy Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia
A study testing Physical Therapy and Rehabilitation Modalities and Conventional Group in people with Exercise and Developmental Dysplasia of the Hip, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Exercise, Developmental Dysplasia of the Hip
- What is being tested?
- Physical Therapy and Rehabilitation Modalities and Conventional Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 informed consent from their families were included.
Who cannot join
- 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 informed consent from their families were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University
Malatya, 44100
Elisa Çalışgan, PhD, 05342462471, elisa.calisgan@inonu.edu.tr
Beül Akyol, PhD, betul.akyol@inonu.edu.tr
About this study
Official title: The Investigation of the Effects of Physical Therapy and Rehabilitation Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia
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.
- Conditions
- Exercise, Developmental Dysplasia of the Hip
- Being tested
- Physical Therapy and Rehabilitation Modalities, Conventional Group
- Keywords
- Dysplasia, Hip subluxation, Dislocation, Rehabilitation
- Medical subject headings
- Motor Activity, Developmental Dysplasia of the Hip, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy and Rehabilitation ModalitiesBehavioural
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.
Conventional GroupBehavioural
As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning was applied.
| Study group | Role | What they receive |
|---|---|---|
| physical therapy and rehabilitation program in addition to conservative treatment | Experimental | 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 Receives: Behavioral: Physical Therapy and Rehabilitation Modalities |
| Conventional Group | Active comparator | As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied Receives: Behavioral: Conventional Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and week 8
Secondary outcomes (8)
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.
Measured: baseline and week 8
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.
Measured: baseline and week 8
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.
Measured: baseline and week 8
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.
Measured: baseline and week 8
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.
Measured: baseline and week 8
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.
Measured: baseline and week 8
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.
Measured: baseline and week 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.
Measured: baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- 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
- Model description
- Experimental, Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Çalışgan, Inonu University
- Investigators
- Elisa Calisgan, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007833
- Sponsor's protocol ID
- 2022/3832
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effects of Physical Therapy and Rehabilitation Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia
- ClinicalTrials.gov ID
- NCT06007833
- Acronym / sponsor ID
- 2022/3832
- Conditions
- Exercise, Developmental Dysplasia of the Hip
- Keywords
- Dysplasia, Hip subluxation, Dislocation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 23 Aug 2023 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental, Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| physical therapy and rehabilitation program in addition to conservative treatment | Experimental | Behavioral: Physical Therapy and Rehabilitation ModalitiesOrthoses 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 |
| Conventional Group | Active comparator | Behavioral: Conventional GroupAs a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- Having neurological problems,
- Meningomyelocele (diagnosed with Spina Bifida),
- Mental retardation and uncooperative,
- Children with inflammation, spasticity, spina bifida, arthrocentesis,
- Down syndrome-related dislocation,
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 |
|---|---|---|
| Physical Therapy and Rehabilitation ModalitiesIn 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. | Behavioural | physical therapy and rehabilitation program in addition to conservative treatment |
| Conventional GroupAs a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning was applied. | Behavioural | Conventional Group |
Primary outcome
The Evaluation of Trunk Control
Time frame: baseline and week 8
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.
8 secondary outcomes
The Evaluation of the Endurance of the Spinal Stability Muscles
Time frame: baseline and week 8
The Evaluation of the Strength of the Spinal Stability Muscles
Time frame: baseline and week 8
The Evaluation with Radiological Imaging of Hip Parameters
Time frame: baseline and week 8
The Assessment of Aerobic Capacity
Time frame: baseline and week 8
The Evaluation of Anaerobic Capacity
Time frame: baseline and week 8
The Evaluation of the Dynamic Balance
Time frame: baseline and week 8
The Evaluation of Functional Mobility and Dynamic Balance
Time frame: baseline and week 8
The Evaluation of Muscle Strength
Time frame: baseline and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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. This study is not recruiting at the moment.
Elisa Calisgan, PhD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Rehabilitation Modalities and Conventional Group in people with Exercise and Developmental Dysplasia of the Hip, run by Inonu University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Çalışgan, PhD (05342462471, elisa.calisgan@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Evaluation of Trunk Control (time frame: baseline and week 8). 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 23 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.