- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04006574
Developmental Hip Dysplasia and Physical Therapy
June 19, 2020 updated by: Esra ATEŞ NUMANOĞLU, Hacettepe University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- age between 20-60 years old
- non-operated (total hip arthroplasty)
Exclusion Criteria:
- neurological disease
- cognitive problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: core stabilization training
Patient with hip dysplasia aged between 20-60, non-operated
|
Core stabilization
Other Names:
|
Active Comparator: traditional physiotherapy and core stabilization
Patient with hip dysplasia aged between 20-60, non-operated
|
Core stabilization
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip Muscle Strength ( muscle isometric strength in Newton)
Time Frame: 6 weeks
|
Muscle Strength will be evaluated by hand held dynamometer
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip Function
Time Frame: 6 weeks
|
Hip Function will be evaluated with scale Harris Hip Score
|
6 weeks
|
Hip Pain
Time Frame: 6 weeks
|
Pain will be evaluated with Digital Analog Scale in numbers 0-10
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Esra ATEŞ NUMANOĞLU, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
January 16, 2020
Study Registration Dates
First Submitted
June 27, 2019
First Submitted That Met QC Criteria
June 29, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
June 22, 2020
Last Update Submitted That Met QC Criteria
June 19, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-1357-18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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