NCT05882981

Brief Summary

It is important to determine how high femoral anteversion, which is one of the lower extremity malalignments, affects physical performance and to what extent it affects the daily life of the individual. As far as we know, there is no study on this subject except for a study conducted by Staheli et al. in 1977. Therefore, the investigators planned to determine whether and to what extent high femoral anteversion has an effect on physical performance in healthy young adults.

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 Oct 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

May 8, 2023

Last Update Submit

January 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Functional performance tests

    Single-leg and double-leg horizontal jump test will be used to evaluate lower extremity functional performance. The tests will be carried out according to the Eurofit test battery (Council of Europe, 1988).

    One day

  • Functional capacity measurement

    Functional capacity will be evaluated with six minute walk test according to the ATS criteria.

    One day

Secondary Outcomes (3)

  • Sit and reach test

    One day

  • Back-leg-chest muscle strength measurement

    One day

  • Hand grip strength measurement

    One day

Study Arms (2)

Study group

22 young adults aged 17-26 years with high femoral anteversion.

Other: Sit and reach testOther: Hand grip strength measurementOther: Back-leg-chest muscle strength measurementOther: Functional performanceOther: Functional capacity

Control group

22 young adults aged 17-26 years with normal femoral anteversion

Other: Sit and reach testOther: Hand grip strength measurementOther: Back-leg-chest muscle strength measurementOther: Functional performanceOther: Functional capacity

Interventions

It will be used to measure the flexibility of the participants.

Control groupStudy group

Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.

Control groupStudy group

An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.

Control groupStudy group

Single-leg and double-leg horizontal jump test will be used to evaluate lower extremity functional performance. The tests will be carried out according to the Eurofit test battery (Council of Europe, 1988).

Control groupStudy group

Functional capacity will be evaluated with six minute walk test according to the ATS criteria.

Control groupStudy group

Eligibility Criteria

Age17 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

22 young adults aged 17-26 years with high femoral anteversion.

You may qualify if:

  • Bilateral increased femoral anteversion
  • Hip internal rotation \>60 degrees, external rotation \<45
  • According to the Craig test, the anteversion angle is between 20-40 degrees
  • Absence of a history of neurological or psychiatric disease
  • Absence of intellectual disability to prevent participation in assessment and treatment
  • Not participating in any exercise/physiotherapy program in the last six months
  • Body mass index within normal limits (18.5-24.9 kg/m2)

You may not qualify if:

  • Having a history of BoNT-A or surgery in the last 6 months
  • Leg length inequality
  • Beighton score of 4 and above
  • Presence of 3rd degree pes planus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic AcidPhysical Functional PerformanceFunctional Residual Capacity

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsIsothiocyanatesIsocyanatesSulfur CompoundsPhysical FitnessHealthPopulation CharacteristicsTotal Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 31, 2023

Study Start

October 20, 2023

Primary Completion

December 20, 2023

Study Completion

January 14, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations