NCT06526715

Brief Summary

The aim of this study is to simulate the orthopedic treatment called Morton's extension on flat foot patients to check balance effects in standing position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

6 days

First QC Date

July 24, 2024

Last Update Submit

August 6, 2024

Conditions

Healthy Subjects

Keywords

balanceFootOrthopedics

Outcome Measures

Primary Outcomes (20)

  • Length in millimetres of the centre of pressures. Untreated

    Length of the centre of pressures described in millimetres.

    Through study completion, an average of 4 days

  • Area of the ellipse. Untreated

    Area of the ellipse in square millimeters.

    Through study completion, an average of 4 days

  • Inclination of the ellipse in degrees.Untreated

    Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.

    Through study completion, an average of 4 days

  • Length-area ratio. Untreated

    Fraction of the length of the ellipse between the surface of the ellipse in millimetres.

    Through study completion, an average of 4 days

  • Delta x. Untreated

    Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.

    Through study completion, an average of 4 days

  • Delta y. Untreated

    Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.

    Through study completion, an average of 4 days

  • Displacement on the major axis or y-axis. Untreated

    Displacement in millimetres of the y-axis.

    Through study completion, an average of 4 days

  • Displacement on the minor axis or x-axis. Untreated

    Displacement in millimetres of the y-axis.

    Through study completion, an average of 4 days

  • Maximum oscillation. Untreated

    Measurement of the length in millimetres of the maximum oscillations.

    Through study completion, an average of 4 days

  • Minimum oscillation in millimetres. Untreated

    Measurement of the length in millimetres of the minimum oscillations

    Through study completion, an average of 4 days

  • Length in millimetres of the centre of pressures with treatment

    Length of the centre of pressures described in millimetres.

    Through study completion, an average of 4 days

  • Area of the ellipse with treatment

    Area of the ellipse in square millimeters.

    Through study completion, an average of 4 days

  • Inclination of the ellipse in degrees with treatment

    Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.

    Through study completion, an average of 4 days

  • Length-area ratio with treatment

    Fraction of the length of the ellipse between the surface of the ellipse in millimetres.

    Through study completion, an average of 4 days

  • Delta x with treatment

    Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.

    Through study completion, an average of 4 days

  • Delta y with treatment

    Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.

    Through study completion, an average of 4 days

  • Displacement on the major axis or y-axis with treatment

    Displacement in millimetres of the y-axis.

    Through study completion, an average of 4 days

  • Displacement on the minor axis or x-axis with treatment

    Displacement in millimetres of the y-axis.

    Through study completion, an average of 4 days

  • Maximum oscillation with treatment

    Measurement of the length in millimetres of the maximum oscillations.

    Through study completion, an average of 4 days

  • Minimum oscillation in millimetres with treatment

    Measurement of the length in millimetres of the minimum oscillations

    Through study completion, an average of 4 days

Study Arms (1)

Morton.s extension treatment

EXPERIMENTAL

Appliation of Morton´s extension treatment simulation

Other: Morton extension

Interventions

Morton extensionOTHER

A Morton extension with a height of 5 mm was insert from the proximal area of the first metatarsal head to the base of the proximal phalanx of the Hallux of the subjects' bare feet using a paper bandage. The material, shape, size, and thickness of the Morton Extension were the same.

Morton.s extension treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women and men aged 18 to 30 with flexible flat feet.

You may not qualify if:

  • Participants who have had any previous limb surgery, and/or previous lower limb trauma within the last year
  • Uncorrected hearing or visual impairment.
  • Lumbar pathology with radicular involvement.
  • Pregnancy.
  • Healthy participants performing strenuous exercise.
  • Diagnosed active or inactive rheumatic or inflammatory disease.
  • Participants consuming alcohol within 24 hours prior to recording or stimulants 6 hours prior to testing (e.g. caffeine).
  • Participants who have a history of injury with residual lower extremity symptoms within the past year.
  • Participants with evidence of a leg length discrepancy (difference in distance from the anterior superior iliac spine to the superior iliac spine at the surface of the most prominent aspect of the medial malleolus) of more than 1 cm 19
  • Having at least 15 degrees of ankle dorsiflexion.
  • Participants with evidence of balance deficit, as determined through oral questioning about falls and by use of the Balance Evaluation Systems Test (BESTest).
  • Participants with neurological pathology with lower limb deformities, sensory-motor disturbances, neuromuscular pathology, or neurovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva María Martínez-Jiménez

León, 24401, Spain

Location

Study Officials

  • Eva María Martínez Jiménez, PhD

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

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
Head of Podiatry, Principal Investigator, and Physiotherapist, profesor

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 30, 2024

Study Start

July 30, 2024

Primary Completion

August 5, 2024

Study Completion

August 6, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)