Hip Dysplasia, CongenitalNCT04006574
Developmental Hip Dysplasia and Physical Therapy
A study testing Exercises in people with Hip Dysplasia, Congenital, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Developmental Hip Displasia (DDH) can cause various degenerations or compensatory adaptations in the spine and knee joint, especially in the hip joint. As a result of adaptations and degeneration, these individuals may experience difficulty in walking and functional activities, lack of stabilization, decreased muscle… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Hip Dysplasia, Congenital
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 16 Jan 2020
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 20-60 years old
- non-operated (total hip arthroplasty)
Who cannot join
- neurological disease
- cognitive problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation the Effects of Core Stabilization Training on Gait, Balance, Muscle Strength, Functions, Fear of Movement and Quality of Life in Individuals With Developmental Hip Dysplasia
Developmental Hip Displasia (DDH) can cause various degenerations or compensatory adaptations in the spine and knee joint, especially in the hip joint. As a result of adaptations and degeneration, these individuals may experience difficulty in walking and functional activities, lack of stabilization, decreased muscle strength and activation, and loss of balance at varying levels. This situation necessitates a holistic, multifaceted rehabilitation in individuals with hip dysplasia. There is no study in the literature that shows a specific physiotherapy and rehabilitation program applied to individuals with DDH. The aim of this study was to investigate the efficacy of classical physiotherapy method in patients with DDH and to compare the efficacy of classical physiotherapy and core stabilization exercise training in treatment.
Read the detailed description
The study will be conducted in two groups. Individuals with DDH will be divided into two groups as conventional physiotherapy group and core stabilization group. It will be ensured that the distribution of the individuals in the groups in a randomized manner, with the disease stages of the two treatment groups being the same and the clinical characteristics are similar. The population of the study, individuals diagnosed with DDH by the orthopaedic surgeon, routinely directed to physiotherapy and rehabilitation, examined by the responsible investigator and who were referred to our clinic for the research, will be evaluated twice(before and after treatment) and will be treated for 3 times a week for 6 weeks. The study will consist of female individuals aged 20-60 who voluntarily agree to participate in the study (2 times evaluation and 18 times treatment). It is planned to involve at least 16 individuals. Individuals who meet the criteria for inclusion in the study and volunteers will be included in the study by signing the Informed Voluntary Consent Form. In Hacettepe University, Department of Physiotherapy and Rehabilitation, pain severity of subjects with DDH will be evaluated with Digital Analogue Scale (SAS) and algometer, joint range of motion with goniometer, muscle strength with digital dynamometer, walking with GaitRite device, balance with Bertec device and hip functions, kineyophobia, questionnaires will be given to evaluate quality of life and mood. After the first evaluation, individuals will be treated 3 times a week for 6 weeks and then the first evaluations will be done again. The data obtained before and after treatment will be compared between the two treatment groups.
- Conditions
- Hip Dysplasia, Congenital
- Being tested
- Exercises
- Keywords
- Developmental Hip Dysplasia, Physiotherapy, Gait, Core Stabilization, Balance
- Medical subject headings
- Hip Dislocation, Congenital, Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Also called Traditional physiotherapy
Core stabilization
| Study group | Role | What they receive |
|---|---|---|
| core stabilization training | Experimental | Patient with hip dysplasia aged between 20-60, non-operated Receives: Other: Exercises |
| traditional physiotherapy and core stabilization | Active comparator | Patient with hip dysplasia aged between 20-60, non-operated Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Muscle Strength ( muscle isometric strength in Newton)
Muscle Strength will be evaluated by hand held dynamometer
Measured: 6 weeks
Secondary outcomes (2)
Hip Function
Hip Function will be evaluated with scale Harris Hip Score
Measured: 6 weeks
Hip Pain
Pain will be evaluated with Digital Analog Scale in numbers 0-10
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Feb 2019
- Primary completion1 Sep 2019
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Dysplasia, CongenitalStudies 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
- Single Blind Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra ATEŞ NUMANOĞLU, Hacettepe University
- Investigators
- Esra ATEŞ NUMANOĞLU, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006574
- Sponsor's protocol ID
- 20-1357-18
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2019
- Last updated
- 22 Jun 2020
- 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 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Effects of Core Stabilization Training on Gait, Balance, Muscle Strength, Functions, Fear of Movement and Quality of Life in Individuals With Developmental Hip Dysplasia
- ClinicalTrials.gov ID
- NCT04006574
- Acronym / sponsor ID
- 20-1357-18
- Conditions
- Hip Dysplasia, Congenital
- Keywords
- Developmental Hip Dysplasia, Physiotherapy, Gait, Core Stabilization, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 5 Jul 2019 (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 Hip Displasia (DDH) can cause various degenerations or compensatory adaptations in the spine and knee joint, especially in the hip joint. As a result of adaptations and degeneration, these individuals may experience difficulty in walking and functional activities, lack of stabilization, decreased muscle strength and activation, and loss of balance at varying levels. This situation necessitates a holistic, multifaceted rehabilitation in individuals with hip dysplasia. There is no study in the literature that shows a specific physiotherapy and rehabilitation program applied to individuals with DDH. The aim of this study was to investigate the efficacy of classical physiotherapy method in patients with DDH and to compare the efficacy of classical physiotherapy and core stabilization exercise training in treatment.
Detailed description
The study will be conducted in two groups. Individuals with DDH will be divided into two groups as conventional physiotherapy group and core stabilization group. It will be ensured that the distribution of the individuals in the groups in a randomized manner, with the disease stages of the two treatment groups being the same and the clinical characteristics are similar. The population of the study, individuals diagnosed with DDH by the orthopaedic surgeon, routinely directed to physiotherapy and rehabilitation, examined by the responsible investigator and who were referred to our clinic for the research, will be evaluated twice(before and after treatment) and will be treated for 3 times a week for 6 weeks. The study will consist of female individuals aged 20-60 who voluntarily agree to participate in the study (2 times evaluation and 18 times treatment). It is planned to involve at least 16 individuals. Individuals who meet the criteria for inclusion in the study and volunteers will be included in the study by signing the Informed Voluntary Consent Form. In Hacettepe University, Department of Physiotherapy and Rehabilitation, pain severity of subjects with DDH will be evaluated with Digital Analogue Scale (SAS) and algometer, joint range of motion with goniometer, muscle strength with digital dynamometer, walking with GaitRite device, balance with Bertec device and hip functions, kineyophobia, questionnaires will be given to evaluate quality of life and mood. After the first evaluation, individuals will be treated 3 times a week for 6 weeks and then the first evaluations will be done again. The data obtained before and after treatment will be compared between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Blind Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| core stabilization training | Experimental | Other: ExercisesPatient with hip dysplasia aged between 20-60, non-operated |
| traditional physiotherapy and core stabilization | Active comparator | Other: ExercisesPatient with hip dysplasia aged between 20-60, non-operated |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 20-60 years old
- non-operated (total hip arthroplasty)
Key exclusion criteria (2 listed)
- neurological disease
- cognitive problems
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 |
|---|---|---|
| ExercisesAlso: Traditional physiotherapyCore stabilization | Other | core stabilization training, traditional physiotherapy and core stabilization |
Primary outcome
Hip Muscle Strength ( muscle isometric strength in Newton)
Time frame: 6 weeks
Muscle Strength will be evaluated by hand held dynamometer
2 secondary outcomes
Hip Function
Time frame: 6 weeks
Hip Pain
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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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.
Esra ATEŞ NUMANOĞLU principal investigator
Hacettepe 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 Exercises in people with Hip Dysplasia, Congenital, run by Hacettepe 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Muscle Strength ( muscle isometric strength in Newton) (time frame: 6 weeks). 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 22 Jun 2020.