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Equinus Deformity of FootEREPSOLMNCT06308380

Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles

A study testing Specific protocol of rehabilitation exercise and Short gastrocnemius surgery. in people with Equinus Deformity of Foot and Gastrocnemius Equinus, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical study is to develop a specialized rehabilitation exercise protocol designed for patients diagnosed with foot pathologies and calf muscle shortening, regardless of their choice to undergo minimally invasive ultrasound-guided surgery. Read more about this study

Who is it for?
Ages 20 to 90 years
What is being tested?
Specific protocol of rehabilitation exercise and Short gastrocnemius surgery.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesSpain
Study dates
10 Mar 2024to 10 Jun 2025
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 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with shortened posterior musculature.
  • Chronic ankle pain.
  • Limitations in activities of daily living.
  • Atypical gait.
  • Clubfoot.

Who cannot join

  • Previous MMII surgeries.
  • Neuropathic pain.
  • Bony cap equinus.
  • Analgesic physiotherapy.

Trial locations and contacts

3 sites in 1 country.

Maria del Mar Aranda, Dra. contact

+34963637412

mariamar.aranda@ucv.es

Spain3 sites, 3 recruiting
  • Clinica Mayral foot center

    Barcelona, Barcelon, 08029

    Jordi Mayral, (+34) 93 339 78 41, barcelona@clinicamayral.com

    Jordi Mayral

    Recruiting
  • Podologia Avançada

    Granollers, Barcelona, 08401

    Lluis Castillo-Sanchez, Dr, 610143173, info@podologiaavanzadabcn.com

    Lluis Castillo, Dr

    Recruiting
  • Clinicas UCV

    Valencia, València, 46001

    Pablo Vera-Ivars, Dr., 963 92 06 24, clinicas.ucv@ucv.es

    Cristina Mico-Salcedo, 963 92 06 24, clinicas.ucv@ucv.es

    Recruiting

Other trials in Spain

About this study

Official title: Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles, Whether or Not Combined With Ultrasound- Guided Surgery

The goal of this clinical study is to develop a specialized rehabilitation exercise protocol designed for patients diagnosed with foot pathologies and calf muscle shortening, regardless of their choice to undergo minimally invasive ultrasound-guided surgery. The primary focus is to assess disparities in outcomes, particularly in the recovery of ankle mobility degrees. Additionally, for patients opting for minimally invasive ultrasound-guided surgery, the study aims to evaluate the resumption of both sporting activities and daily routines using the aforementioned specific rehabilitation protocol.

The primary questions this study aims to answer are:

Read more
  • How does the proposed rehabilitation protocol impact ankle mobility recovery for patients with foot pathologies and calf muscle shortening?
  • What are the differences observed in the return to sporting activities and daily life among patients undergoing minimally invasive ultrasound-guided surgery, following the prescribed protocol?

Participants enrolled in this study will be engaged in:

Undertaking the specified rehabilitation exercises tailored for foot pathologies and calf muscle shortening.

Those opting for minimally invasive ultrasound-guided surgery will follow the same rehabilitation protocol post-surgery to assess its impact on their return to normal activities.

If there exists a comparison group:

Researchers will compare participants who undergo minimally invasive ultrasound-guided surgery against those who choose other treatment options to discern any differential effects on ankle mobility recovery and resumption of activities.

Read the detailed description

Calf muscle tightness and limited ankle dorsiflexion range of motion are associated with various foot pathologies, including plantar fasciitis, Achilles tendinitis, and altered gait patterns. While conservative rehabilitation exercises are first-line treatment, minimally invasive ultrasound-guided gastrocnemius recession can be considered for refractory cases. However, no studies have compared using the same rehabilitation protocol post-surgery versus without surgery. The aim of this randomized controlled trial is to evaluate the efficacy of a specialized 12-week rehabilitation protocol on ankle dorsiflexion range of motion in patients with foot pathologies and calf tightness. Secondary objectives are to compare post-surgical outcomes in patients undergoing minimally invasive ultrasound-guided gastrocnemius recession followed by the 12-week rehabilitation protocol, versus patients only undergoing the rehabilitation protocol, in terms of ankle dorsiflexion range of motion, foot posture and plantar pressures, pain scores, function scores, and return to activities.

A parallel group design will be used, with participants assigned to two groups: Group A will undergo the rehabilitation protocol only and Group B will undergo the rehabilitation protocol after ultrasound-assisted gastrocnemius surgery. Adult patients between 20 and 90 years of age with clubfoot pathology and gastrocsoleus contracture with calf strain will be recruited. The target sample size is 40 patients, equally distributed in the two groups.

The study protocol will consist of assessing participants at baseline for calf muscle length, ankle dorsiflexion range of motion, foot posture, plantar pressures, pain and function. Group A will undergo the 12-week rehabilitation protocol. Group B will undergo ultrasound-guided minimally invasive surgery first, followed by the 12-week rehabilitation protocol. Evaluations will be performed at Pre-surgery, 2 months, 6 months.

Statistical analysis will compare the two groups on all outcome measures using appropriate statistical tests. Expected results are improved ankle dorsiflexion range of motion in both groups, with greater improvements in Group B post-surgery. This study will provide evidence on a targeted rehabilitation protocol for calf tightness, and also insight into the added benefits of minimally invasive surgery when combined with focused rehabilitation.

Being tested
Specific protocol of rehabilitation exercise, Short gastrocnemius surgery.
Keywords
foot deformity, calf shortening, foot and ankle disease, stretching and muscle strengthening, exercise post surgery
Medical subject headings
Contracture, Foot Deformities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specific protocol of rehabilitation exerciseProcedure or surgery

    Also called Exercise

    Specific protocol of rehabilitation exercise

  • Short gastrocnemius surgery.Procedure or surgery

    During surgery, a partial release of the gastrocnemius muscle tendon is performed to relieve tension and allow greater range of motion. This procedure is typically performed on an outpatient basis and under local or regional anesthesia, which allows for a quicker recovery compared to more invasive surgeries.

Study groups in NCT06308380
Study groupRoleWhat they receive
Rehabilitation onlyActive comparatorAll patients who do not wish to undergo mini- invasive surgery to lengthen the calf muscles are part of the control group. They will be subjected to a specific protocol of rehabilitation exercise 3times a week for 12 weeks.
Receives: Procedure: Specific protocol of rehabilitation exercise
SurgeryExperimentalAll patients who wish to undergo mini invasive surgery to lengthen the calf muscles are part of the experimental group. they will be subjected to a specific protocol of rehabilitation exercise exercise 3times a day every day for 4weeks.
Receives: Procedure: Specific protocol of rehabilitation exercise; Procedure: Short gastrocnemius surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait Analysis

    The Gait Analysis is an examination useful for studying patterns, aided by instruments that measure the load on each limb and overall ambulation. The gait cycle ia s particularly complex phenomenon, resulting from the coordination between the nervous system, musculoskeletal system, and sensory input. The patient is required to walk (at varying intervals) on a treadmill or directly on a platform. It's a non invasive examination.

    Measured: Pre-surgery, 2 months, 6 months.

  2. Baropodometric examination

    The baropodometric examination, a pivotal tool in studying plantar pressure distribution, is conducted on the Zebris platform. This platform provides a detailed and precise analysis of pressures exerted on the plantar surface during walking, enabling a comprehensive assessment of alterations in load distribution on the feet. Zebris' technology allows for gathering relevant data on pressure points and load areas, facilitating the identification of abnormal gait patterns and postural imbalances. Integrated within the Zebris platform, this examination becomes an invaluable resource for comprehensive biomechanical assessment and personalized treatment planning for various foot pathologies.

    Measured: Pre-surgery, 2 months, 6 months.

Secondary outcomes (5)
  1. Passive ankle mobility

    It is a tool that measures muscle strength and is used to evaluate the Passive ankle mobility test. The latter allows us to evaluate the equine.Measurement in degrees.

    Measured: Pre-surgery, 2 months, 6 months.

  2. Short Form Health Survey 36 score

    It's a self administered questionnaire filled out by the patient, aimed at quantifying health status and measuring health related quality of life.

    On this 0 - 100 scale of the The Short Form-36 Health Survey(SF-36), the higher the score obtained, the better the health status. Thus, 0 represents the worst state of health and 100 the best state of health as measured by the SF-36.

    Measured: Pre-surgery, 2 months, 6 months.

  3. Foot Function Index

    It is a questionnaire consisting of 23 items designed to assess the impact that foot pathologies have on the patient's perceived health status in terms of pain, disability and activity limitation.

    Measured: Pre-surgery, 2 months, 6 months.

  4. American Orthopedic Foot and Ankle Score

    The AOFAS Ankle-Hindfoot Scale was designed by the American Foot and Ankle Society to provide an international method to assess the clinical status of the ankle and foot.

    This questionnaire incorporates subjective and objective factors that are scored using a numerical scale and describe variables of function, alignment and pain. The score ranges from 0 to 100 depending on the degree of limitation of the patient.

    Measured: Pre-surgery, 2 months, 6 months.

  5. Halasi score

    The Halasi Ankle Activity Score is a ten-point scoring system in which various sports and physical activities are divided into 10 groups according to the biomechanical load on the ankle; for each sport discipline, three levels can be selected ranging from recreational level (more than one hour per week) to professional or international elite level.

    Measured: Pre-surgery, 2 months, 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start10 Mar 2024
  3. Primary completion1 Jul 2024
  4. Study completion10 Jun 2025 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308380
Sponsor's protocol ID
UCV/2022-2023/158
Acronym
EREPSOLM
Status last verified
Jul 2024
First submitted
19 Jan 2024
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pearce CJ, Seow D, Lau BP. Correlation Between Gastrocnemius Tightness and Heel Pain Severity in Plantar Fasciitis. Foot Ankle Int. 2021 Jan;42(1):76-82. doi: 10.1177/1071100720955144. Epub 2020 Sep 13.

    PubMed 32924578
  • Nakale NT, Strydom A, Saragas NP, Ferrao PNF. Association Between Plantar Fasciitis and Isolated Gastrocnemius Tightness. Foot Ankle Int. 2018 Mar;39(3):271-277. doi: 10.1177/1071100717744175. Epub 2017 Dec 4.

    PubMed 29198141
  • Medeiros DM, Martini TF. Chronic effect of different types of stretching on ankle dorsiflexion range of motion: Systematic review and meta-analysis. Foot (Edinb). 2018 Mar;34:28-35. doi: 10.1016/j.foot.2017.09.006. Epub 2017 Oct 27.

    PubMed 29223884
  • Meyer DC, Werner CM, Wyss T, Vienne P. A mechanical equinometer to measure the range of motion of the ankle joint: interobserver and intraobserver reliability. Foot Ankle Int. 2006 Mar;27(3):202-5. doi: 10.1177/107110070602700309.

    PubMed 16539903
  • Barouk P, Barouk LS. Clinical diagnosis of gastrocnemius tightness. Foot Ankle Clin. 2014 Dec;19(4):659-67. doi: 10.1016/j.fcl.2014.08.004. Epub 2014 Sep 26.

    PubMed 25456715
  • Villanueva M, Iborra A, Rodriguez G, Sanz-Ruiz P. Ultrasound-guided gastrocnemius recession: a new ultra-minimally invasive surgical technique. BMC Musculoskelet Disord. 2016 Oct 3;17(1):409. doi: 10.1186/s12891-016-1265-7.

    PubMed 27716217
  • Moroni S, Fernandez-Gibello A, Nieves GC, Montes R, Zwierzina M, Vazquez T, Garcia-Escudero M, Duparc F, Moriggl B, Konschake M. Anatomical basis of a safe mini-invasive technique for lengthening of the anterior gastrocnemius aponeurosis. Surg Radiol Anat. 2021 Jan;43(1):53-61. doi: 10.1007/s00276-020-02536-1. Epub 2020 Jul 23.

    PubMed 32705404
  • Baraja-Vegas L, Martin-Rodriguez S, Piqueras-Sanchiz F, Faundez-Aguilera J, Bautista IJ, Barrios C, Garcia-Escudero M, Fernandez-de-Las-Penas C. Localization of Muscle Edema and Changes on Muscle Contractility After Dry Needling of Latent Trigger Points in the Gastrocnemius Muscle. Pain Med. 2019 Jul 1;20(7):1387-1394. doi: 10.1093/pm/pny306.

    PubMed 30715456
  • Cobacho MT, Barcia JM, Freijo-Gutierrez V, Caballero-Gomez F, Ferrer-Torregrosa J. A Predictive Model for Gastrocnemius Tightness in Forefoot Pain and Intractable Plantar Keratosis of the Second Rocker. J Am Podiatr Med Assoc. 2021 May 1;111(3):Article_12. doi: 10.7547/18-024.

    PubMed 34144595
  • Head J, Mallows A, Debenham J, Travers MJ, Allen L. The efficacy of loading programmes for improving patient-reported outcomes in chronic midportion Achilles tendinopathy: A systematic review. Musculoskeletal Care. 2019 Dec;17(4):283-299. doi: 10.1002/msc.1428. Epub 2019 Nov 25.

    PubMed 31763774

Questions about this trial

What is this clinical trial studying?

A study testing Specific protocol of rehabilitation exercise and Short gastrocnemius surgery. in people with Equinus Deformity of Foot and Gastrocnemius Equinus, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 3 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristina Razzano (+34963637412, cristina.razzano@mail.ucv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Analysis (time frame: Pre-surgery, 2 months, 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308380, which also lists 10 linked publications.

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 11 May 2025.

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