- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05647616
Strengthening of the Peroneus Longus Muscle in Patients With Dorsiflexed First Ray
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pedro V Munuera-Martínez, Ph.D
- Phone Number: 696437996
- Email: pmunuera@us.es
Study Locations
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Seville, Spain, 41009
- Recruiting
- Department of Podiatry
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Contact:
- Pedro V Munuera-Martínez, Ph.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Flexible dorsiflexed first ray.
Exclusion Criteria:
- Traumatisms on the feet in the last 12 months.
- Previous foot surgery.
- Hallux abducto-valgus.
- Being in treatment with foot orthoses.
- Systemic musculoskeletal disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Strengthening exercises
The participants in this group will be given instructions to follow a resistance exercises to strengthen the peroneus longs muscle.
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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.
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No Intervention: Control
Participants in this group will be given no treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plantar pressure under the first metatarsal head
Time Frame: Four weeks
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The maximum plantar pressure detected by a pressure plate with capacitive sensors under the first metatarsal head load area.
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Four weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pedro V Munuera-Martínez, Ph.D, University of Seville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Peroneus Longus and First Ray
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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