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Developmental Hip Dysplasia and Physical Therapy

Primary Purpose

Hip Dysplasia, Congenital

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia, Congenital focused on measuring Developmental Hip Dysplasia, Physiotherapy, Gait, Core Stabilization, Balance

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 20-60 years old
  • non-operated (total hip arthroplasty)

Exclusion Criteria:

  • neurological disease
  • cognitive problems

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

core stabilization training

traditional physiotherapy and core stabilization

Arm Description

Patient with hip dysplasia aged between 20-60, non-operated

Patient with hip dysplasia aged between 20-60, non-operated

Outcomes

Primary Outcome Measures

Hip Muscle Strength ( muscle isometric strength in Newton)
Muscle Strength will be evaluated by hand held dynamometer

Secondary Outcome Measures

Hip Function
Hip Function will be evaluated with scale Harris Hip Score
Hip Pain
Pain will be evaluated with Digital Analog Scale in numbers 0-10

Full Information

First Posted
June 27, 2019
Last Updated
June 19, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04006574
Brief Title
Developmental Hip Dysplasia and Physical Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
January 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dysplasia, Congenital
Keywords
Developmental Hip Dysplasia, Physiotherapy, Gait, Core Stabilization, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single Blind Randomized Control Trial
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
core stabilization training
Arm Type
Experimental
Arm Description
Patient with hip dysplasia aged between 20-60, non-operated
Arm Title
traditional physiotherapy and core stabilization
Arm Type
Active Comparator
Arm Description
Patient with hip dysplasia aged between 20-60, non-operated
Intervention Type
Other
Intervention Name(s)
Exercises
Other Intervention Name(s)
Traditional physiotherapy
Intervention Description
Core stabilization
Primary Outcome Measure Information:
Title
Hip Muscle Strength ( muscle isometric strength in Newton)
Description
Muscle Strength will be evaluated by hand held dynamometer
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hip Function
Description
Hip Function will be evaluated with scale Harris Hip Score
Time Frame
6 weeks
Title
Hip Pain
Description
Pain will be evaluated with Digital Analog Scale in numbers 0-10
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
age between 20-60 years old, non-operated (total hip arthroplasty)
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 20-60 years old non-operated (total hip arthroplasty) Exclusion Criteria: neurological disease cognitive problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra ATEŞ NUMANOĞLU
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Developmental Hip Dysplasia and Physical Therapy

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