Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles (EREPSOLM)

April 22, 2024 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir

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:

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelon
      • Barcelona, Barcelon, Spain, 08029
        • Recruiting
        • Clinica Mayral foot center
        • Principal Investigator:
          • Cristina Razzano
        • Sub-Investigator:
          • Simone Moroni
        • Contact:
        • Sub-Investigator:
          • Jordi Mayral
    • Barcelona
      • Granollers, Barcelona, Spain, 08401
        • Recruiting
        • Podologia Avançada
        • Contact:
        • Sub-Investigator:
          • Lluis Castillo, Dr
        • Principal Investigator:
          • Cristina Razzano
        • Sub-Investigator:
          • Simone Moroni
    • València
      • Valencia, València, Spain, 46001
        • Recruiting
        • Clinicas UCV
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Ferrer-Torregrosa, Dr
        • Principal Investigator:
          • Juan Vicente-Mampel, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rehabilitation only
All 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.
Procedure: Specific protocol of rehabilitation exercise
Specific protocol of rehabilitation exercise
Other Names:
  • Exercise
Experimental: Surgery
All 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.
Procedure: Specific protocol of rehabilitation exercise
Specific protocol of rehabilitation exercise
Other Names:
  • Exercise
Procedure: Short gastrocnemius 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-surgery, 2 months, 6 months.
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.
Pre-surgery, 2 months, 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-surgery, 2 months, 6 months.
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.
Pre-surgery, 2 months, 6 months.
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.
Pre-surgery, 2 months, 6 months.
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.
Pre-surgery, 2 months, 6 months.
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.
Pre-surgery, 2 months, 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-surgery, 2 months, 6 months.
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).
Pre-surgery, 2 months, 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Investigators

  • Study Director: Javier Ferrer-Torregrosa, Dr., FundaciónUcv
  • Study Director: Juan Vicente-Mampel, Dr., FundaciónUcv

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

March 10, 2025

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCV/2022-2023/158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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