Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles

NCT06308380 | Recruiting

• 1 other identifier: UCV/2022-2023/158
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Equinus Deformity of Foot; Gastrocnemius Equinus; Contracture

Keywords

foot deformity; calf shortening; foot and ankle disease; stretching and muscle strengthening; exercise post surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  Pre-surgery, 2 months, 6 months.

• 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.

  Pre-surgery, 2 months, 6 months.

Secondary Outcomes (5)

• Passive ankle mobility

  Pre-surgery, 2 months, 6 months.

• Short Form Health Survey 36 score

  Pre-surgery, 2 months, 6 months.

• Foot Function Index

  Pre-surgery, 2 months, 6 months.

• American Orthopedic Foot and Ankle Score

  Pre-surgery, 2 months, 6 months.

• Halasi score

  Pre-surgery, 2 months, 6 months.

Other Outcomes (2)

• Olerud and Molander ankle score.

  Pre-surgery, 2 months, 6 months.

• Visual Analogue Scale

  Pre-surgery, 2 months, 6 months.

Study Arms (2)

Rehabilitation only

ACTIVE COMPARATOR

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

Surgery

EXPERIMENTAL

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; Procedure: Short gastrocnemius surgery.

Interventions

Specific protocol of rehabilitation exercise PROCEDURE

Specific protocol of rehabilitation exercise

Also known as: Exercise

Rehabilitation only; Surgery

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.

Surgery

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (3)

Podologia Avançada

Granollers, Barcelona, 08401, Spain

RECRUITING

Clinica Mayral foot center

Barcelona, Barcelon, 08029, Spain

RECRUITING

Clinicas UCV

Valencia, València, 46001, Spain

RECRUITING

Related Publications (10)

• 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.

  PMID: 32924578 BACKGROUND

• 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.

  PMID: 29198141 BACKGROUND

• 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.

  PMID: 29223884 BACKGROUND

• 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.

  PMID: 16539903 BACKGROUND

• 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.

  PMID: 25456715 BACKGROUND

• 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.

  PMID: 27716217 BACKGROUND

• 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.

  PMID: 32705404 BACKGROUND

• 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.

  PMID: 30715456 BACKGROUND

• 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.

  PMID: 34144595 BACKGROUND

• 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.

  PMID: 31763774 BACKGROUND

MeSH Terms

Conditions

Contracture; Foot Deformities

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Javier Ferrer-Torregrosa, Dr.

  FundaciónUcv

  STUDY DIRECTOR

• Juan Vicente-Mampel, Dr.

  FundaciónUcv

  STUDY DIRECTOR

Central Study Contacts

Cristina Razzano

CONTACT

+34963637412; cristina.razzano@mail.ucv.es

Maria del Mar Aranda, Dra.

CONTACT

+34963637412; mariamar.aranda@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: March 13, 2024
• Study Start: March 10, 2024
• Primary Completion: July 1, 2024
• Study Completion: June 10, 2025
• Last Updated: May 11, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)