Do All Patients With Congenital Hip Dysplasia Corrected Operatively Need Physiotherapy

NCT05238935 | Unknown DMC

• 1 other identifier: 1920
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dysplasia of the Hip

Keywords

DDH; physiotherapy; rehabilitation; home program

Outcome Measures

Primary Outcomes (8)

• 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).

  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).

  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).

  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).

  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 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).

  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 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).

  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 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).

  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 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).

  Patient will be evaluated after 6 weeks of treatment (16 weeks postoperatively)

Study Arms (2)

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).

Other: prescribed physiotherapy course

Interventions

prescribed physiotherapy course OTHER

provide full assessment and treatment program as postoperative rehabilitation management

intervention (treatment) group

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Operated for DDH correction previously
• patient with neurological involvement
• patient with other congenital deformity
• patient with cognitive problems

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead

Study Sites (1)

Dr. Hadeel Alsaleh

Kuwait City, Kuwait

RECRUITING

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hadeel H Alsaleh, PhD

CONTACT

0096565064141; golden_land85@hotmail.com

maryam alsaffar, master

CONTACT

0096599944540

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the primary investigator and the outcome assessor will assess all of the patients and will be blinded to the groups allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapy and rehabilitation specialist

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 14, 2022
• Study Start: February 23, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Feb-April 2023 data will be destroyed after publication
• 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.

Locations

KU (1)