Back to resultsOrthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
Primary Purpose
Healthy Subjects
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Morton extension
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Subjects focused on measuring metatarsalgia, foot, orthopedics
Eligibility Criteria
Inclusion Criteria: no history of trauma to the foot; the presence of at least 10° of dorsiflexion at the ankle with the knee fully dorsiflexed; unrestricted motion of the functional subtalar joint of 30°; unrestricted motion along the longitudinal axis of the midtarsal joint of 15°; unrestricted nonweight-bearing motion of the first ray of at least 8 mm; greater than 50° of dorsiflexion of the hallux to the first metatarsal bisection during nonweight-bearing; age greater than 18 years and younger than 60 years; at the time of data collection, no lower limb dysfunction or chronic injury; and no evidence of a non-fixed deformity at first MTP and first metatarsal cuneiform joints. Exclusion Criteria: plantar corns and calluses, hallux valgus and lesser toe deformities, diabetes, any abnormality in the lower extremity that may affect gait.
Sites / Locations
- Eva María Martínez-Jimenez
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Morton extension
Arm Description
Experimental group con Morton Extension application
Outcomes
Primary Outcome Measures
Before Morton Extension Medium pressure
Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
Before Morton Extension Maximum pressure
Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
After Morton Extension Medium pressure
Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
After Morton Extension Maximum pressure
Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05879094
Brief Title
Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
Official Title
Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
June 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayuben Private Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to simulate the orthopedic treatment called Morton's extension on non-deformed patients to check the effects on each metatarsal head on its static footprint.
Detailed Description
The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on non-deformed patients to verify the effects on each metatarsal head on its static footprint, specifically the mean pressures and before and after the application of the morton extension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
Keywords
metatarsalgia, foot, orthopedics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morton extension
Arm Type
Experimental
Arm Description
Experimental group con Morton Extension application
Intervention Type
Other
Intervention Name(s)
Morton extension
Intervention Description
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.
Primary Outcome Measure Information:
Title
Before Morton Extension Medium pressure
Description
Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
Time Frame
Through study completion, an average of 1 week
Title
Before Morton Extension Maximum pressure
Description
Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
Time Frame
Through study completion, an average of 1 week
Title
After Morton Extension Medium pressure
Description
Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
Time Frame
Through study completion, an average of 1 week
Title
After Morton Extension Maximum pressure
Description
Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.
Time Frame
Through study completion, an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no history of trauma to the foot;
the presence of at least 10° of dorsiflexion at the ankle with the knee fully dorsiflexed;
unrestricted motion of the functional subtalar joint of 30°;
unrestricted motion along the longitudinal axis of the midtarsal joint of 15°;
unrestricted nonweight-bearing motion of the first ray of at least 8 mm;
greater than 50° of dorsiflexion of the hallux to the first metatarsal bisection during nonweight-bearing;
age greater than 18 years and younger than 60 years;
at the time of data collection, no lower limb dysfunction or chronic injury; and
no evidence of a non-fixed deformity at first MTP and first metatarsal cuneiform joints.
Exclusion Criteria:
plantar corns and calluses,
hallux valgus and lesser toe deformities,
diabetes,
any abnormality in the lower extremity that may affect gait.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva María Martínez-Jimenez, PhD
Organizational Affiliation
Mayuben Private Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eva María Martínez-Jimenez
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
We'll reach out to this number within 24 hrs