Do All Patients With Congenital Hip Dysplasia Corrected Operatively Need Physiotherapy
Primary Purpose
Developmental Dysplasia of the Hip
Status
Recruiting
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
prescribed physiotherapy course
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Dysplasia of the Hip focused on measuring DDH, physiotherapy, rehabilitation, home program
Eligibility Criteria
Inclusion Criteria:
- Patient diagnosed with DDH Tonnis grade 1-4 operated for open reduction, osteotomy with/without femoral shortening.
- patient is able to walk preoperatively
- aged between 1.5-5
Exclusion Criteria:
- Operated for DDH correction previously
- patient with neurological involvement
- patient with other congenital deformity
- patient with cognitive problems
Sites / Locations
- Dr. Hadeel AlsalehRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
intervention (treatment) group
Arm Description
this group will be treated as per the common practice postoperatively and will have the home program prescribed by the orthopedic surgeon
Patients in the intervention group will be treated with conventional physiotherapy 3 times a week for 6 weeks (18 times treatment).
Outcomes
Primary Outcome Measures
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
pediatric balance scale
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
pediatric balance scale
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
pediatric balance scale
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
pediatric balance scale
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
Secondary Outcome Measures
Full Information
NCT ID
NCT05238935
First Posted
January 19, 2022
Last Updated
August 24, 2022
Sponsor
Ministry of Health, Kuwait
1. Study Identification
Unique Protocol Identification Number
NCT05238935
Brief Title
Do All Patients With Congenital Hip Dysplasia Corrected Operatively Need Physiotherapy
Official Title
Do All Patients With Congenital Hip Dysplasia Corrected Operativell Need Physiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Kuwait
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Developmental Dysplasia of the Hip (DDH) is a common condition among young children that could range in severity. in most sever cases, surgical intervention is the best choice to correct the hip abnormality with the aim of restoring optimal functional ability. Referring patient for physiotherapy treatment post operative is not a common practice and surgeons relay on children natural developmental milestone in their recovery. however, prescribed physiotherapy treatment could promote maximum functional recovery and wellness. the aim of this research is (1) to evaluate the functional deference between patients who had conventional physiotherapy treatment program and patients who had home program prescribed by the orthopedic surgeon (2) to investigate what might be the underlying risk factors that could enhance or prohibit satisfactory functional level post operatively.
all individuals diagnosed with DDH and operated by Dr. Saleh Alsaifi (an orthopedic surgeon at alrazi orthopedic hospital) will be invited to participate in this study. The study will look at the children development in fictional ability postoperatively. not being referred to physiotherapy is a common practice, so the patients in the intervention group will benefit from having regular physiotherapy treatment with no risk at all. the study run from Alrazi orthopedic hospital in kuwait. the research is a collaboration between an orthopedic surgeon (Dr. Saleh Alsaifi) and physiotherapy team and it is expected to recruit all of the eligible patients through 12 months period (approximately 50 patients) then, the data will be sorted for analysis and reporting. the study is not funded with no personal interest.
Detailed Description
The population of the study: individuals diagnosed with DDH and operated by the orthopedic surgeon. Surgical procedures will include: open reduction, pelvic osteotomy (DEGA osteotomy) with/without femoral shortening. Individuals with operated DDH will be divided into two groups as conventional physiotherapy group and home program group. It will be ensured that the distribution of the individuals in the groups in a randomized manner, with the disease grades and operative procedures of the two treatment groups being the same and the clinical characteristics are similar.
The study will consist of children aged 1.5-5 who's guardian voluntarily agreed to participate in the study. It is planned to involve up to 50 children. Individuals who meet the inclusion criteria and had their guardian agreed to volunteer will be included in the study by signing the Informed Voluntary Consent Form. The participants will be examined by the responsible examiner in physiotherapy clinic (blinded to the allocated group). Patients in the control group will be given a home program by the orthopedic surgeon (common practice). Patients in the intervention group will be treated with conventional physiotherapy 3 times a week for 6 weeks (4 times evaluation and 18 times treatment).
As an outcome measure, the examiner will evaluate patient's hip function (using modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji) and pediatric balance scale. patient will have a baseline data preoperatively. Then, patient will have the first postoperative evaluation10 weeks post-operatively (time of the removal of spica cast). After the first post-operative evaluation, individuals will be treated 3 times a week for 3 weeks and then the first evaluations will be done again then the same process will be repeated. Thus, Patient will be evaluated four times by the same examiner (before the operation, after 10 weeks [removal of spica cast], after 3 weeks of treatment [13 weeks postoperatively] and after 6 weeks of treatment [16 weeks postoperatively]). The data obtained before and after treatment and the data between the two groups will be compared.
Primary outcome measure modified outcome evaluation standard for congenital dislocation of the hip by Zhou will be used to evaluate child's functional level and Ji and pediatric balance scale will be used to evaluate child's balance. both outcome measures will be through physical examination of hip joint range of motion and some physical examination. the tests will be obtained 4 times (preoperative, postoperative base line (after the removal of the spica cast), 3 weeks post operative, 6 weeks postoperative)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dysplasia of the Hip
Keywords
DDH, physiotherapy, rehabilitation, home program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals who meet the inclusion criteria and had their guardian agreed to volunteer will be included in the study by signing the Informed Voluntary Consent Form and will be randomly allocated into either control group or treatment group. Patients in the control group will be given a home program by the orthopedic surgeon (common practice). Patients in the intervention (treatment) group will be treated with conventional physiotherapy 3 times a week for 6 weeks (4 times evaluation and 18 times treatment). all participants will be examined by the responsible examiner in physiotherapy clinic (blinded to the allocated group) at four main points: preoperative, postoperative (after the removal of spica cast), 3 weeks postoperative, 6 weeks postoperative.
Masking
InvestigatorOutcomes Assessor
Masking Description
the primary investigator and the outcome assessor will assess all of the patients and will be blinded to the groups allocation.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
this group will be treated as per the common practice postoperatively and will have the home program prescribed by the orthopedic surgeon
Arm Title
intervention (treatment) group
Arm Type
Experimental
Arm Description
Patients in the intervention group will be treated with conventional physiotherapy 3 times a week for 6 weeks (18 times treatment).
Intervention Type
Other
Intervention Name(s)
prescribed physiotherapy course
Intervention Description
provide full assessment and treatment program as postoperative rehabilitation management
Primary Outcome Measure Information:
Title
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
Description
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
Time Frame
Patient will be evaluated before the operation (baseline)
Title
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
Description
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
Time Frame
Patient will be evaluated after 10 weeks (removal of spica cast)
Title
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
Description
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
Time Frame
Patient will be evaluated after 3 weeks of treatment (13 weeks postoperatively)
Title
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
Description
evaluate the hip functional ability will start by measuring the hip range of motion in degrees and then graded from 0-5 where 5 is patient is able to do 100% of normal range of motion and 0 is less than 60% of normal ROM. this assessment will evaluate the hip flexion (normal ROM is 130-140),Hip abduction in extension position (normal ROM is 70),Hip abduction in flexion position (normal ROM is30-45), hip abduction (normal ROM is 20-30),Hip internal rotation (normal ROM is 40-50),Hip external rotation (normal ROM is 30-40). further more, the assessment tool will evaluate the pain ( in the scale of no, occasional, frequently), squat (normal, mildly, difficult), limping (none, mild, sever),Trendelenburg (negative, mild, positive), and shortening (none, mild<2cm, sever>2cm).
Time Frame
Patient will be evaluated after 6 weeks of treatment (16 weeks postoperatively)
Title
pediatric balance scale
Description
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
Time Frame
Patient will be evaluated before the operation (baseline)
Title
pediatric balance scale
Description
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
Time Frame
Patient will be evaluated after 10 weeks (removal of spica cast)
Title
pediatric balance scale
Description
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
Time Frame
Patient will be evaluated after 3 weeks of treatment (13 weeks postoperatively)
Title
pediatric balance scale
Description
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include
sitting to standing
standing to sitting
transfers.
standing unsupported
sitting unsupported
standing with eyes closed
standing with feet together.
standing one foot in front
standing on one foot
turning 360 degrees
turning to look behind
retrieving object from the floor
placing alternate foot on a stool
reaching forward with outstretched arm. each task will be scored utilizing the 0-4 scale. the child's performance should be scored based upon the lowest criteria which describe the child best performance (each task has its own criteria of performance description scored from 0-4 that will be used to guide scoring procedure).
Time Frame
Patient will be evaluated after 6 weeks of treatment (16 weeks postoperatively)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient diagnosed with DDH Tonnis grade 1-4 operated for open reduction, osteotomy with/without femoral shortening.
patient is able to walk preoperatively
aged between 1.5-5
Exclusion Criteria:
Operated for DDH correction previously
patient with neurological involvement
patient with other congenital deformity
patient with cognitive problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadeel H Alsaleh, PhD
Phone
0096565064141
Email
golden_land85@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
maryam alsaffar, master
Phone
0096599944540
Facility Information:
Facility Name
Dr. Hadeel Alsaleh
City
Kuwait
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadeel H Alsaleh, PhD
Phone
0096565064141
Email
golden_land85@hotmail.com
First Name & Middle Initial & Last Name & Degree
maryam Alsaffar, master
Phone
0096599944540
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
anonymous data will be shared for analysis
IPD Sharing Time Frame
Feb-April 2023 data will be destroyed after publication
IPD Sharing Access Criteria
original data will be stored in a curly locked file section and only the primary investigator will have an access to this data.
Learn more about this trial
Do All Patients With Congenital Hip Dysplasia Corrected Operatively Need Physiotherapy
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