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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04006574
Other study ID # 20-1357-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date January 16, 2020

Study information

Verified date June 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 16, 2020
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- age between 20-60 years old

- non-operated (total hip arthroplasty)

Exclusion Criteria:

- neurological disease

- cognitive problems

Study Design


Intervention

Other:
Exercises
Core stabilization

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hip Muscle Strength ( muscle isometric strength in Newton) Muscle Strength will be evaluated by hand held dynamometer 6 weeks
Secondary Hip Function Hip Function will be evaluated with scale Harris Hip Score 6 weeks
Secondary Hip Pain Pain will be evaluated with Digital Analog Scale in numbers 0-10 6 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05869851 - Developmental Dysplasia of the Hip: Observation vs. Bracing N/A