NCT04669327

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 5, 2020

Last Update Submit

December 13, 2020

Conditions

Keywords

Idiopathic scoliosis-gait-moment

Outcome Measures

Primary Outcomes (1)

  • hip and knee abductor moment

    peak abductor moment normalized to body weight

    one session of 40 minutes.

Study Arms (2)

Normal

normal subjects

Other: gait analysis

Scoliosis

subjects with moderate idiopathic scoliosis

Other: gait analysis

Interventions

Vicon nexus with MTI force plate form

NormalScoliosis

Eligibility Criteria

Age14 Years - 17 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

normal subjects and subjects with moderate idiopathic scoliosis

You may qualify if:

  • normal subjects free from any musculoskeletal problems
  • subjects with moderate idiopathic scoliosis (cobb angle 25-35)

You may not qualify if:

  • any musculoskeletal affection rather than scoliosis, neurological manifestations, or previous major surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Applied Medical Sciences

Ta'if, Mecca Region, 62552, Saudi Arabia

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • HAtem H Allam, Ass. Prof.

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 5, 2020

First Posted

December 16, 2020

Study Start

September 1, 2020

Primary Completion

November 15, 2020

Study Completion

November 30, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

the used consent form indicated that the IPD would be confidential and cannot be published.

Locations