Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06308380

Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles

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:

* 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Mayral foot center, Barcelona, Barcelon, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Specific protocol of rehabilitation exercise

Procedure

Specific protocol of rehabilitation exercise

Other names: Exercise

Short gastrocnemius surgery.

Procedure

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.

Primary outcomes

  1. Gait Analysis

    Time frame: Pre-surgery, 2 months, 6 months.

    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.

  2. Baropodometric examination

    Time frame: Pre-surgery, 2 months, 6 months.

    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.

Secondary outcomes

  1. Passive ankle mobility

    Time frame: Pre-surgery, 2 months, 6 months.

    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.

  2. Short Form Health Survey 36 score

    Time frame: Pre-surgery, 2 months, 6 months.

    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.

  3. Foot Function Index

    Time frame: Pre-surgery, 2 months, 6 months.

    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.

  4. American Orthopedic Foot and Ankle Score

    Time frame: Pre-surgery, 2 months, 6 months.

    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.

  5. Halasi score

    Time frame: Pre-surgery, 2 months, 6 months.

    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.

Other outcomes

  1. Olerud and Molander ankle score.

    Time frame: Pre-surgery, 2 months, 6 months.

    it is a functional assessment scale that uses a numerical scoring approach to measure a patient's function or status in relation to nine different items. In this case, the variable measured through this scale is a continuous quantitative variable. the scale assigns scores ranging from 0 to 100, based on the patient's responses or evaluations regarding the nine mentioned items. Higher scores indicate better functioning or a more favorable health status, while lower scores indicate impaired functioning or a less favorable health state.

  2. Visual Analogue Scale

    Time frame: Pre-surgery, 2 months, 6 months.

    A 10-centimeter horizontal line is used, with extreme expressions of a symptom at both ends; absence or lesser intensity on the left and greater intensity on the right. The patient marks the point indicating intensity, measures it with a millimeter ruler, and expresses it in centimeters. The classification is: Mild pain (less than 3), moderate pain (between 4 and 7), and severe pain (8 or higher).

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Razzano

CONTACT

[email protected]

+34963637412

Maria del Mar Aranda, Dra.

CONTACT

[email protected]

+34963637412

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

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

Acronym: EREPSOLM

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.