NCT07552103

Brief Summary

The aim of this study is to investigate the effect of thyroid dysfunction on pain, symptoms, attitudes, fatigue, foot parameters, muscle strength, and lower extremity performance in women with a menstrual cycle, and to compare these findings with those of healthy controls.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress44%
Mar 2026Aug 2026

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Foot Function Index

    The Foot Function Index consists of 23 items divided into three subscales: pain, disability, and activity limitations. The nine-item pain subscale measures the level of foot pain in various situations, while the nine-item disability subscale determines the degree of difficulty in performing various functional activities due to foot problems. The activity limitation subscale, consisting of five items, is used to assess activity limitations caused by foot problems. Higher scores indicate greater pain, disability, and activity limitations.

    At baseline (Day 1)

  • Foot Posture Index-6

    Consists of 6 parameters. These are: palpation of the head of the talus, increase/decrease in the arch beneath the lateral malleolus, inversion/eversion of the calcaneus, prominence in the talonavicular joint region, structure of the medial longitudinal arch, and abduction/adduction of the forefoot. These parameters are assessed visually or by palpation.

    At baseline (Day 1)

  • Sit-to-Stand Test

    This test evaluates individuals' lower extremity muscle strength and functional performance. In the starting position, the participant's arms are crossed in front of the torso and their feet are in full contact with the floor. Participants are asked to sit down and stand up as quickly as possible for 30 seconds from a standard chair with back support but no armrests. The total number of sit-to-stand cycles is recorded.

    At baseline (Day 1)

  • Trunk Flexor Endurance Test

    The participant lies down with the hips and knees flexed to 90°, arms crossed over the chest at shoulder level, and feet in a fixed position. The test begins when the participant's trunk is moved into a supported sitting position with 60° flexion while maintaining this initial position. The trunk support is removed, and the participant is asked to maintain this position for as long as possible. The test ends when the 60° angle between the floor and the upper trunk changes, and the elapsed time is recorded in seconds.

    At baseline (Day 1)

  • Trunk Lateral Flexor Endurance Test

    The participant lies on their non-dominant side on a treatment table with their legs extended. The upper foot is placed in front of the lower foot for support. The upper arm is placed across the chest toward the opposite shoulder. The elbow of the lower arm is positioned in flexion and placed so that support can be obtained from the elbow and forearm. The participant is instructed to lift their hips off the ground to form a straight line with their entire body, using support from their elbows and feet. The test ends when the participant loses the test position, and the duration for which the position was maintained is recorded in seconds. The test is performed bilaterally.

    At baseline (Day 1)

  • Longitudinal Arch Measurement

    This method, which describes the position of the navicular tubercle relative to the medial malleolus and the line of the first metatarsophalangeal joint, was first developed by McPoil and colleagues. The grading of pes planus is based on the degree to which the navicular tubercle deviates from the Feiss line and approaches the ground.

    At baseline (Day 1)

Secondary Outcomes (5)

  • Menstrual Symptom Scale

    At baseline (Day 1)

  • Visual Analog Scale

    At baseline (Day 1)

  • Menstrual Attitude Scale

    At baseline (Day 1)

  • Multidimensional Fatigue Inventory-20

    At baseline (Day 1)

  • Time up and go test

    At baseline (Day 1)

Study Arms (3)

hypothyroid group

This group includes patients diagnosed with hypothyroidism. Participants will undergo clinical assessments and data collection. No intervention will be applied.

hyperthyroidism group

This group includes patients diagnosed with hyperthyroidism. Participants will undergo clinical assessments and data collection. No intervention will be applied.

healthy group

This group includes healthy patients. Participants will undergo clinical assessments and data collection. No intervention will be applied.

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of menstruating women diagnosed with hypothyroidism or hyperthyroidism who apply to the Endocrinology Outpatient Clinic of Usak Training and Research Hospital, and menstruating women who are companions of patients applying to the same clinic for the healthy control group, who meet the inclusion criteria and agree to participate in the study.

You may qualify if:

  • Be between the ages of 18 and 55
  • Be female
  • Be able to communicate in Turkish
  • Be willing to participate in the study
  • Have signed the informed consent form
  • Have a menstrual cycle

You may not qualify if:

  • Diagnosed with severe cognitive impairment or dementia
  • Having an active psychiatric diagnosis
  • Having undergone any surgery in the past year
  • Having any rheumatic, neurological, or cancer-related condition
  • Using a walking aid
  • Having a cardiopulmonary condition that could cause significant functional limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak Training and Research Hospital, Endocrinology Outpatient Clinic

Uşak, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations