Developmental Dysplasia of the HipNCT05238935
Do All Patients With Congenital Hip Dysplasia Corrected Operatively Need Physiotherapy
A study testing prescribed physiotherapy course in people with Developmental Dysplasia of the Hip, run by Ministry of Health, Kuwait at 1 site in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- prescribed physiotherapy course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteKuwait
- Study dates
- 23 Feb 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Operated for DDH correction previously
- patient with neurological involvement
- patient with other congenital deformity
- patient with cognitive problems
Trial locations and contacts
1 site in 1 country.
maryam alsaffar, master contact
Kuwait1 site, 1 recruiting
- Recruiting
Dr. Hadeel Alsaleh
Kuwait City
Hadeel H Alsaleh, PhD, 0096565064141, golden_land85@hotmail.com
maryam Alsaffar, master, 0096599944540
About this study
Official title: Do All Patients With Congenital Hip Dysplasia Corrected Operativell Need Physiotherapy
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.
Read the 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)
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- prescribed physiotherapy course
- Keywords
- DDH, physiotherapy, rehabilitation, home program
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescribed physiotherapy courseOther
provide full assessment and treatment program as postoperative rehabilitation management
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | this group will be treated as per the common practice postoperatively and will have the home program prescribed by the orthopedic surgeon |
| intervention (treatment) group | Experimental | Patients in the intervention group will be treated with conventional physiotherapy 3 times a week for 6 weeks (18 times treatment). Receives: Other: prescribed physiotherapy course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Patient will be evaluated before the operation (baseline)
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).
Measured: Patient will be evaluated after 10 weeks (removal of spica cast)
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).
Measured: Patient will be evaluated after 3 weeks of treatment (13 weeks postoperatively)
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).
Measured: Patient will be evaluated after 6 weeks of treatment (16 weeks postoperatively)
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).
Measured: Patient will be evaluated before the operation (baseline)
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).
Measured: Patient will be evaluated after 10 weeks (removal of spica cast)
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).
Measured: Patient will be evaluated after 3 weeks of treatment (13 weeks postoperatively)
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).
Measured: Patient will be evaluated after 6 weeks of treatment (16 weeks postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start23 Feb 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Hadeel Alsaleh, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238935
- Sponsor's protocol ID
- 1920
- Status last verified
- Aug 2022
- First submitted
- 19 Jan 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymous data will be shared for analysis
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do All Patients With Congenital Hip Dysplasia Corrected Operativell Need Physiotherapy
- ClinicalTrials.gov ID
- NCT05238935
- Acronym / sponsor ID
- 1920
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- DDH, physiotherapy, rehabilitation, home program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –this group will be treated as per the common practice postoperatively and will have the home program prescribed by the orthopedic surgeon |
| intervention (treatment) group | Experimental | Other: prescribed physiotherapy coursePatients in the intervention group will be treated with conventional physiotherapy 3 times a week for 6 weeks (18 times treatment). |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Operated for DDH correction previously
- patient with neurological involvement
- patient with other congenital deformity
- patient with cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prescribed physiotherapy courseprovide full assessment and treatment program as postoperative rehabilitation management | Other | intervention (treatment) group |
Primary outcome
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level
Time frame: Patient will be evaluated before the operation (baseline)
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
Time frame: Patient will be evaluated after 10 weeks (removal of spica cast)
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
Time frame: Patient will be evaluated after 3 weeks of treatment (13 weeks postoperatively)
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
Time frame: Patient will be evaluated after 6 weeks of treatment (16 weeks postoperatively)
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
Time frame: Patient will be evaluated before the operation (baseline)
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include 1. sitting to standing 2. standing to sitting 3. transfers. 4. standing unsupported 5. sitting unsupported 6. standing with eyes closed 7. standing with feet together. 8. standing one foot in front 9. standing on one foot 10. turning 360 degrees 11. turning to look behind 12. retrieving object from the floor 13. placing alternate foot on a stool 14. 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
Time frame: Patient will be evaluated after 10 weeks (removal of spica cast)
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include 1. sitting to standing 2. standing to sitting 3. transfers. 4. standing unsupported 5. sitting unsupported 6. standing with eyes closed 7. standing with feet together. 8. standing one foot in front 9. standing on one foot 10. turning 360 degrees 11. turning to look behind 12. retrieving object from the floor 13. placing alternate foot on a stool 14. 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
Time frame: Patient will be evaluated after 3 weeks of treatment (13 weeks postoperatively)
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include 1. sitting to standing 2. standing to sitting 3. transfers. 4. standing unsupported 5. sitting unsupported 6. standing with eyes closed 7. standing with feet together. 8. standing one foot in front 9. standing on one foot 10. turning 360 degrees 11. turning to look behind 12. retrieving object from the floor 13. placing alternate foot on a stool 14. 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
Time frame: Patient will be evaluated after 6 weeks of treatment (16 weeks postoperatively)
the pediatric balance scale will evaluate the child's balance through asking the child to do 14 different tasks that include 1. sitting to standing 2. standing to sitting 3. transfers. 4. standing unsupported 5. sitting unsupported 6. standing with eyes closed 7. standing with feet together. 8. standing one foot in front 9. standing on one foot 10. turning 360 degrees 11. turning to look behind 12. retrieving object from the floor 13. placing alternate foot on a stool 14. 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: Yes. anonymous data will be shared for analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maryam alsaffar, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prescribed physiotherapy course in people with Developmental Dysplasia of the Hip, run by Ministry of Health, Kuwait at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeel H Alsaleh, PhD (0096565064141, golden_land85@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified outcome evaluation standard for congenital dislocation of the hip by Zhou and Ji will be used to evaluate child's functional level (time frame: Patient will be evaluated before the operation (baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.