NCT05899855

Brief Summary

To investigate the effect of various foot positions affect knee and ankle proprioception, balance, vertical jump, and muscle activity in individuals with flexible and rigid flatfoot and chronic ankle instability

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

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

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 2, 2023

Last Update Submit

June 2, 2023

Conditions

Flatfoot

Outcome Measures

Primary Outcomes (4)

  • knee proprioception

    knee proprioception

    2-3 months

  • ankle proprioception

    ankle proprioception

    2-3 months

  • Vertical jump measurements

    Vertical jump measurements

    2-3 months

  • Electromyographical activity (EMG)

    Electromyographical activity (EMG)

    2-3 months

Study Arms (2)

Group 1

30 subjects with rigid flatfoot and chronic ankle instability

Other: No intervention

Group II

30 subjects with flexible flatfoot and chronic ankle instability

Other: No intervention

Interventions

No interventionOTHER

No intervention

Group 1Group II

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Seventy-six participants met the inclusion and exclusion of this study. These participants were screened for the type of FF. We chose 30 for each group (60 total) to accomplish the balance between groups. Group 1: 30 subjects with rigid FF and chronic ankle instability, and Group 2: 30 subjects with flexible FF and chronic ankle instability. All participants were blinded to study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Beni-Suef University

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

July 1, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

June 12, 2023

Record last verified: 2023-06