First Ray DorsiflexionNCT05647616
Strengthening of the Peroneus Longus Muscle in Patients With Dorsiflexed First Ray
A study testing Strengthening exercises in people with First Ray Dorsiflexion, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- First Ray Dorsiflexion
- What is being tested?
- Strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Flexible dorsiflexed first ray.
Who cannot join
- Traumatisms on the feet in the last 12 months.
- Previous foot surgery.
- Hallux abducto-valgus.
- Being in treatment with foot orthoses.
- Systemic musculoskeletal disease.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- First Ray Dorsiflexion
- Being tested
- Strengthening exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening exercises | Experimental | The participants in this group will be given instructions to follow a resistance exercises to strengthen the peroneus longs muscle. Receives: Other: Strengthening exercises |
| Control | No intervention | Participants in this group will be given no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Feb 2023
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Ray DorsiflexionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro V. Munuera-Martínez, University of Seville
- Investigators
- Pedro V Munuera-Martínez, Ph.D, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647616
- Sponsor's protocol ID
- Peroneus Longus and First Ray
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening of the Peroneus Longus Muscle in Patients With Dorsiflexed First Ray
- ClinicalTrials.gov ID
- NCT05647616
- Acronym / sponsor ID
- Peroneus Longus and First Ray
- Conditions
- First Ray Dorsiflexion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening exercises | Experimental | Other: Strengthening exercisesThe participants in this group will be given instructions to follow a resistance exercises to strengthen the peroneus longs muscle. |
| Control | No intervention | –Participants in this group will be given no treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Flexible dorsiflexed first ray.
Key exclusion criteria (5 listed)
- Traumatisms on the feet in the last 12 months.
- Previous foot surgery.
- Hallux abducto-valgus.
- Being in treatment with foot orthoses.
- Systemic musculoskeletal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening exercisesParticipants 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. | Other | Strengthening exercises |
Primary outcome
Maximum plantar pressure under the first metatarsal head
Time frame: Four weeks
The maximum plantar pressure detected by a pressure plate with capacitive sensors under the first metatarsal head load area.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro V Munuera-Martínez, Ph.D study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening exercises in people with First Ray Dorsiflexion, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plantar pressure under the first metatarsal head (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.