NCT05647616

Brief Summary

BACKGROUND: The first metatarsal and medial cuneiform form an important functional unit in the foot called "first ray". The first ray normal function requires that it load part of the body weight in the last period of the stance phase of gait. A dorsiflexed first ray may exist due to abnormal function of the peroneus longus muscle. OBJECTIVE: To evaluate the improvement in first ray function in tha push-off phase of gait after a 4-week strengthening programme for the peroneus longus. SUBJECTS: Patients with flexible dorsiflexed first ray. INTERVENTIONS: Patients will be randomly assigned to either group A, which will receive instructions for a strengthening programme of the peroneus longus muscle, or group B, which will receive no treatment. MAIN MEASURES: The primary outcomes will be mean and maximum plantar pressure under the first metatarsal head.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration 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

First Submitted

Initial submission to the registry

December 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

December 2, 2022

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum plantar pressure under the first metatarsal head

    The maximum plantar pressure detected by a pressure plate with capacitive sensors under the first metatarsal head load area.

    Four weeks

Study Arms (2)

Strengthening exercises

EXPERIMENTAL

The participants in this group will be given instructions to follow a resistance exercises to strengthen the peroneus longs muscle.

Other: Strengthening exercises

Control

NO INTERVENTION

Participants in this group will be given no treatment.

Interventions

Participants in group A will be required to complete 12 sessions in 4 to 6 weeks. Resistance-Bands will be used to do ankle plantar flexion and eversion (3 sets of 10 repetitions). Participants will have to be seated on the floor with the knee extended and instructed to perform the movement at the ankle joint without allowing extraneous movement at hip and knee. The resistance band will be doubled and securely attached to the base of a table. The training resistance will be determined by calculating 70% of the resting length of the resistance band and adding this distance to the resting length of the resistance band. Using this calculated distance, the examiner will place a mark to which the resistance band will be stretched during exercise performance on the floor. Each week a study investigator will track each participant's completion. Participants will be instructed to move through their entire range of motion for the direction of each exercise.

Strengthening exercises

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Flexible dorsiflexed first ray.

You may not qualify if:

  • Traumatisms on the feet in the last 12 months.
  • Previous foot surgery.
  • Hallux abducto-valgus.
  • Being in treatment with foot orthoses.
  • Systemic musculoskeletal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Podiatry

Seville, 41009, Spain

Location

Study Officials

  • Pedro V Munuera-Martínez, Ph.D

    University of Seville

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor Titular de Universidad

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 12, 2022

Study Start

February 1, 2023

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations