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Physical Therapy Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia

Primary Purpose

Exercise, Developmental Dysplasia of the Hip

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical Therapy and Rehabilitation Modalities
Conventional Group
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise focused on measuring Dysplasia, Hip subluxation, Dislocation, Rehabilitation

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

physical therapy and rehabilitation program in addition to conservative treatment

Conventional Group

Arm Description

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

As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 10, 2023
Last Updated
August 18, 2023
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT06007833
Brief Title
Physical Therapy Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Developmental Dysplasia of the Hip
Keywords
Dysplasia, Hip subluxation, Dislocation, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, Randomized Controlled Study
Masking
Participant
Masking Description
Participants didn't know taking which exercise treatment methods.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
physical therapy and rehabilitation program in addition to conservative treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy and Rehabilitation Modalities
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Group
Intervention Description
As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning was applied.
Primary Outcome Measure Information:
Title
The Evaluation of Trunk Control
Description
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.
Time Frame
baseline and week 8
Secondary Outcome Measure Information:
Title
The Evaluation of the Endurance of the Spinal Stability Muscles
Description
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.
Time Frame
baseline and week 8
Title
The Evaluation of the Strength of the Spinal Stability Muscles
Description
"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.
Time Frame
baseline and week 8
Title
The Evaluation with Radiological Imaging of Hip Parameters
Description
Femoral head ossification in mm, femoral inclination angle in degrees, acetabular index developments in degrees will be examined.
Time Frame
baseline and week 8
Title
The Assessment of Aerobic Capacity
Description
The 1-min walk test is used to evaluate the walking capacity of a pediatric individual, which is defined as the maximum walking speed.
Time Frame
baseline and week 8
Title
The Evaluation of Anaerobic Capacity
Description
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.
Time Frame
baseline and week 8
Title
The Evaluation of the Dynamic Balance
Description
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.
Time Frame
baseline and week 8
Title
The Evaluation of Functional Mobility and Dynamic Balance
Description
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.
Time Frame
baseline and week 8
Title
The Evaluation of Muscle Strength
Description
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.
Time Frame
baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa Çalışgan, PhD
Phone
05342462471
Email
elisa.calisgan@inonu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Betül Akyol, PhD
Phone
05052924448
Email
betül.akyol@inonu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Calisgan, PhD
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44100
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Çalışgan, PhD
Phone
05342462471
Email
elisa.calisgan@inonu.edu.tr
First Name & Middle Initial & Last Name & Degree
Beül Akyol, PhD
Email
betul.akyol@inonu.edu.tr

12. IPD Sharing Statement

Learn more about this trial

Physical Therapy Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia

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