NCT07827846

Brief Summary

This study aims to evaluate the short- and long-term effects of toe spread-out exercises, performed under supervision for 3 months, on the angular severity of deformity and the electromechanical activity, stiffness, and thickness of the abductor hallucis muscle, as well as its contribution to functional status, in individuals with juvenile hallux valgus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 15, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
Last Updated

September 18, 2026

Status Verified

November 1, 2025

Enrollment Period

5 days

First QC Date

September 9, 2026

Last Update Submit

September 14, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cross sectional area

    CSA of m. abductor hallucis with ultrasound (cm²)

    From enrollment to the end of treatment at 12 weeks

  • Shear Wave Elastography

    Measurement SWE with ultrasound (m. abductor hallucis) (cm)

    From enrollment to the end of treatment at 12 weeks

  • Multidimensional Nil Hallux Valgus Scale

    The scale has a score range of 0-60, with higher score indicating increased HV symptoms, complaints, and functional disorder.

    From enrollment to the end of treatment at 12 weeks

  • Hallux Valgus Angle (x-ray)

    From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL
Other: Toe Spread Out Exercises

Interventions

Standart protocol toe spread out exercise

Intervention Group

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of JHV,
  • Mild or moderate deformity confirmed radiographically,
  • Flexible hallux valgus deformity,
  • Willingness to participate in the study.

You may not qualify if:

  • Neurological disorders,
  • Systemic diseases,
  • Spinal disorders (e.g., lumbar disc herniation, lumbar spinal stenosis, or scoliosis),
  • Intermittent claudication,
  • Idiopathic numbness or tingling of the lower extremities,
  • Previous lower-extremity surgery,
  • Fractures, ligament injuries, or muscle injuries involving the lower extremities within the previous six months,
  • Treatment for any foot-related condition during the previous six months.
  • Withdrawal Criteria:
  • Unable to correctly perform the exercise protocol,
  • Failed to attend scheduled assessments,
  • Unable to continue the prescribed intervention,
  • SWE measurements could not be obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazıt University

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 18, 2026

Study Start

November 15, 2025

Primary Completion

November 20, 2025

Study Completion

February 28, 2026

Last Updated

September 18, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations