Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles

NCT ID: NCT06308380

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-10

Study Completion Date

2025-06-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Equinus Deformity of Foot Gastrocnemius Equinus Contracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Specific protocol of rehabilitation exercise

Intervention Type PROCEDURE

Specific protocol of rehabilitation exercise

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.

Group Type EXPERIMENTAL

Specific protocol of rehabilitation exercise

Intervention Type PROCEDURE

Specific protocol of rehabilitation exercise

Short gastrocnemius surgery.

Intervention Type 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.

Interventions

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Specific protocol of rehabilitation exercise

Specific protocol of rehabilitation exercise

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Exercise

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Universidad Católica de Valencia San Vicente Mártir

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javier Ferrer-Torregrosa, Dr.

Role: STUDY_DIRECTOR

FundaciónUcv

Juan Vicente-Mampel, Dr.

Role: STUDY_DIRECTOR

FundaciónUcv

Locations

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Podologia Avançada

Granollers, Barcelona, Spain

Site Status RECRUITING

Clinica Mayral foot center

Barcelona, Barcelon, Spain

Site Status RECRUITING

Clinicas UCV

Valencia, València, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Cristina Razzano

Role: CONTACT

+34963637412

Maria del Mar Aranda, Dra.

Role: CONTACT

+34963637412

Facility Contacts

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Lluis Castillo-Sanchez, Dr

Role: primary

610143173

Jordi Mayral

Role: primary

(+34) 93 339 78 41

Pablo Vera-Ivars, Dr.

Role: primary

963 92 06 24

Cristina Mico-Salcedo

Role: backup

963 92 06 24

References

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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.

Reference Type BACKGROUND
PMID: 32924578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29198141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29223884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16539903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25456715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27716217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32705404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30715456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34144595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31763774 (View on PubMed)

Other Identifiers

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UCV/2022-2023/158

Identifier Type: -

Identifier Source: org_study_id

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