Scoliosis IdiopathicNCT04669327
Hip and Knee Moments Normal and With Scoliosis
An observational study of Scoliosis Idiopathic, run by Taif University at 1 site in Saudi Arabia.
Trial summary
Kinetic analysis appears to be useful in providing objective information regarding the gait abilities of scoliotic patients which is difficult to be observed in a clinical setting. Objective: the aim of the study was to analyze the hip and knee peak abductor moments during gait in subjects with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 14 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- gait analysis
- How many people
- 44 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2020to 30 Nov 2020
- Phase
- Observational
- 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 14 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Study population: normal subjects and subjects with moderate idiopathic scoliosis
Who may be able to join
- normal subjects free from any musculoskeletal problems
- subjects with moderate idiopathic scoliosis (cobb angle 25-35)
Who cannot join
- any musculoskeletal affection rather than scoliosis, neurological manifestations, or previous major surgeries
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Applied Medical Sciences
Ta'if, Mecca Region, 62552
About this study
Official title: Hip and Knee Abductor Moments in Normal Subjects and Subjects With Idiopathic Scoliosis: Comparative Study
Kinetic analysis appears to be useful in providing objective information regarding the gait abilities of scoliotic patients which is difficult to be observed in a clinical setting. Objective: the aim of the study was to analyze the hip and knee peak abductor moments during gait in subjects with idiopathic scoliosis.
Read the detailed description
The hip and knee abductors' moments normalized to body weight have been investigated in normal subjects and subjects with idiopathic scoliosis. The scoliosis group included a twenty-two-moderate idiopathic dorso-lumbar single scoliotic curve. The control group contained a normal twenty-two subjects. 3D motion analysis system and force plat were used for data collection for hip and knee abductor moment. MANOVA was used to study the difference between normal and scoliotic groups' hip and knee abductor moments in both lower limbs. at alpha level of significance of 0.05.
- Conditions
- Scoliosis Idiopathic
- Being tested
- gait analysis
- Keywords
- Idiopathic scoliosis-gait-moment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait analysisOther
Vicon nexus with MTI force plate form
| Study group | Role | What they receive |
|---|---|---|
| Normal | normal subjects Receives: Other: gait analysis | |
| Scoliosis | subjects with moderate idiopathic scoliosis Receives: Other: gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip and knee abductor moment
peak abductor moment normalized to body weight
Measured: one session of 40 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Sep 2020
- Primary completion15 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Hatem Allam, Taif University
- Investigators
- HAtem H Allam, Ass. Prof., Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669327
- Sponsor's protocol ID
- 331
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the used consent form indicated that the IPD would be confidential and cannot be published.
Publications
Karol L., Halliday, Gourineni P (2000).: Gait and function after intraarticular hip arthrodesis during a dolescence. J. Bone Joint Surg Am 82: 561-569. Stephen J. and Stricker M. (2002): The Malaligned Adolescent SpinePart 1: Idiopathic Adolescent Scoliosis.International Pediatrics (17): 43-47. Sucato D., Hedequist D. and Karol L(1998).: Gait analysis in idiopathic scoliosis before and after surgery: a comparison of the pre- and postoperative muscle activation pattern. Eur Spine J 7(1): 6-11. Allington N. and Bowen J. (1996): Adolescent idiopathic scoliosis: treatment with the Wilmington brace: A comparison of full-time and part-time use. J Bone Joint Surg 78: 1056-1062. Burwell R., Cole A., Cook T., Grivas T., Kiel A., Moulton A., Thirlwall A., Upadhyay S., Webb J. andWemyss S (2004).: Pathogenesis of idiopathic scoliosis. J Bone Joint Surg 86(9): 2005-2014.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip and Knee Abductor Moments in Normal Subjects and Subjects With Idiopathic Scoliosis: Comparative Study
- ClinicalTrials.gov ID
- NCT04669327
- Acronym / sponsor ID
- 331
- Conditions
- Scoliosis Idiopathic
- Keywords
- Idiopathic scoliosis-gait-moment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Dec 2020 (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.
Kinetic analysis appears to be useful in providing objective information regarding the gait abilities of scoliotic patients which is difficult to be observed in a clinical setting. Objective: the aim of the study was to analyze the hip and knee peak abductor moments during gait in subjects with idiopathic scoliosis.
Detailed description
The hip and knee abductors' moments normalized to body weight have been investigated in normal subjects and subjects with idiopathic scoliosis. The scoliosis group included a twenty-two-moderate idiopathic dorso-lumbar single scoliotic curve. The control group contained a normal twenty-two subjects. 3D motion analysis system and force plat were used for data collection for hip and knee abductor moment. MANOVA was used to study the difference between normal and scoliotic groups' hip and knee abductor moments in both lower limbs. at alpha level of significance of 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Other: gait analysisnormal subjects |
| Scoliosis | – | Other: gait analysissubjects with moderate idiopathic scoliosis |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- normal subjects and subjects with moderate idiopathic scoliosis
Key inclusion criteria (2 listed)
- normal subjects free from any musculoskeletal problems
- subjects with moderate idiopathic scoliosis (cobb angle 25-35)
Key exclusion criteria (1 listed)
- any musculoskeletal affection rather than scoliosis, neurological manifestations, or previous major surgeries
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 |
|---|---|---|
| gait analysisVicon nexus with MTI force plate form | Other | Normal, Scoliosis |
Primary outcome
hip and knee abductor moment
Time frame: one session of 40 minutes.
peak abductor moment normalized to body weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- BackgroundKarol L., Halliday, Gourineni P (2000).: Gait and function after intraarticular hip arthrodesis during a dolescence. J. Bone Joint Surg Am 82: 561-569. Stephen J. and Stricker M. (2002): The Malaligned Adolescent SpinePart 1: Idiopathic Adolescent Scoliosis.International Pediatrics (17): 43-47. Sucato D., Hedequist D. and Karol L(1998).: Gait analysis in idiopathic scoliosis before and after surgery: a comparison of the pre- and postoperative muscle activation pattern. Eur Spine J 7(1): 6-11. Allington N. and Bowen J. (1996): Adolescent idiopathic scoliosis: treatment with the Wilmington brace: A comparison of full-time and part-time use. J Bone Joint Surg 78: 1056-1062. Burwell R., Cole A., Cook T., Grivas T., Kiel A., Moulton A., Thirlwall A., Upadhyay S., Webb J. andWemyss S (2004).: Pathogenesis of idiopathic scoliosis. J Bone Joint Surg 86(9): 2005-2014.
- Individual participant dataSharing planned: No. the used consent form indicated that the IPD would be confidential and cannot be published.
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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.
HAtem H Allam, Ass. Prof. principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by Taif University at 1 site in Saudi Arabia.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 16 Dec 2020. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hip and knee abductor moment (time frame: one session of 40 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669327, which also lists 1 linked publication.
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 16 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.