Clinical trial NCT06308380: Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles
Official title: Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles, Whether or Not Combined With Ultrasound- Guided Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Equinus Deformity of Foot
Gastrocnemius Equinus
Contracture
Keywords: foot deformity
calf shortening
foot and ankle disease
stretching and muscle strengthening
exercise post surgery
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gait Analysis
timeFrame: Pre-surgery, 2 months, 6 months.
measure: Baropodometric examination
timeFrame: Pre-surgery, 2 months, 6 months.
Secondary outcomes:
measure: Passive ankle mobility
timeFrame: Pre-surgery, 2 months, 6 months.
measure: Short Form Health Survey 36 score
timeFrame: Pre-surgery, 2 months, 6 months.
measure: Foot Function Index
timeFrame: Pre-surgery, 2 months, 6 months.
measure: American Orthopedic Foot and Ankle Score
timeFrame: Pre-surgery, 2 months, 6 months.
measure: Halasi score
timeFrame: Pre-surgery, 2 months, 6 months.
Other outcomes:
measure: Olerud and Molander ankle score.
timeFrame: Pre-surgery, 2 months, 6 months.
measure: Visual Analogue Scale
timeFrame: Pre-surgery, 2 months, 6 months.
Locations:
city: Granollers
country: Spain
facility: Podologia Avançada
state: Barcelona
city: Barcelona
country: Spain
facility: Clinica Mayral foot center
state: Barcelon
city: Valencia
country: Spain
facility: Clinicas UCV
state: València
Study officials:
affiliation: FundaciónUcv
name: Javier Ferrer-Torregrosa, Dr.
role: STUDY_DIRECTOR
affiliation: FundaciónUcv
name: Juan Vicente-Mampel, Dr.
role: STUDY_DIRECTOR
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