The Acute Effect Comparisons of Manual Therapy Or Ankle Motion in Individuals Who Had Achilles Tendon Repair

October 30, 2023 updated by: Fırat Tan, Hacettepe University

The Acute Effect Comparisons of Manual Therapy Application to Ankle Soft Tissues or To Ankle Joint on Ankle Motion, Functional Status, and Passive Mechanical Properties of Muscle in Individuals Who Had Achilles Tendon Repair

Achilles tendon rupture is common among physically active individuals. Limitations, decreases in the level of standing on heel rise, and due to these limitations, failures in functional activities such as returning to sports, walking, running, jumping and performance tests are observed. Manual therapy methods included in rehabilitation programs are an effective option in solving these problems. The aim of the study is to investigate the effects of Compressive Myofascial Release and Ankle joint mobilization on ankle joint movement, functional tests, elasticity and stiffness of the muscle-tendon complex and muscle tone parameters in individuals who underwent Achilles tendon repair.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Achilles tendon rupture is common among physically active individuals. It has been reported that 73% of all Achilles tendon ruptures are sports-related and injuries frequently occur between the ages of 30-49. Conservative or surgical treatments can be applied after Achilles tendon ruptures. After Achilles tendon injuries and repair, decreases in Soleus muscle strength and endurance, changes in lower extremity muscle activation levels, decreases in Gastro-Soleus muscle circumference, increase in Achilles tendon thickness and stiffness, decreases in elasticity, elongations in the Achilles tendon, ankle dorsiflexion range of motion. Limitations, decreases in the level of standing on heel rise, and due to these limitations, failures in functional activities such as returning to sports, walking, running, jumping and performance tests are observed. Manual therapy methods included in rehabilitation programs are an effective option in solving these problems. The aim of the study is to investigate the effects of Compressive Myofascial Release and Ankle joint mobilization on ankle joint movement, functional tests, elasticity and stiffness of the muscle-tendon complex and muscle tone parameters in individuals who underwent Achilles tendon repair. Compressive myofascial release will be applied to a group that has undergone Achilles tendon repair surgery, and ankle mobilization will be applied to another group. Muscle-tendon passive mechanical properties will be evaluated with Myoton-3 before and after the applications. Toe elevation level, ankle joint range of motion and Achilles tendon rest angle will be evaluated before and after the application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • Ankara, Eyalet/Yerleşke, Turkey, 06100

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Being male between the ages of 18-55,

    • Having unilateral Achilles tendon repair performed for at least 6 months,
    • No open wound,
    • No history of fracture accompanying Achilles injury.

Exclusion Criteria:

  • • Presence of a history of repeated Achilles tendon rupture,

    • Having a rupture or tendon injury on the contralateral side,
    • Having a neurological deficit,
    • Having a history of injury in any of the lower extremity joints for the last 1 year,
    • Having a history of surgery other than Achilles tendon repair in any of the lower extremities,
    • Having a history of corticosteroids applied to the Achilles tendon,

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Compressive myofascial release (cmr)
Participants in the CMR group were instructed to lie prone on the treatment table with their feet off the end of the table. The clinician began the treatment by bending the knee to 90° and shaking the muscle belly of the triceps surae group for 30 seconds. Next, the knee was fully extended, and CMR was performed on the medial and lateral sides of the Achilles tendon for 1 minute, followed by the musculotendinous junction for 2 minutes. Treatment consisted of broad strokes applied with the clinician's knuckles to release superficial restrictions, followed by more specific strokes applied with the clinician's thumb to any located restrictions. Strokes were applied at a contact point of 45° to the tissue, with pressure directed from distal to proximal. At the end of the intervention, the clinician shook the belly of the triceps surae complex for 30 seconds. The same examiner (T.S.) applied all CMR treatments.
Other: Compressive Myofascial Release
Compressive myofascial release is manual therapy technics.
Experimental: ankle mobilization
The joint mobilization group received two sets of ankle joint mobilizations. Each set consisted of two-minutes of Grade III anterior-to-posterior talocrural joint mobilizations with a one-minute rest between sets with the patient in a long-sitting position. This mobilization was operationally defined as large-amplitude, one-second rhythmic oscillations from the mid- to end ROM with translation taken to tissue resistance
Other: Ankle mobilisation
ankle mobilization is manual therapy technics.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Passive Mechanical Properties
Time Frame: 2 year
The device measures the stiffness value in Newtons/meter (N/m).The MG measurement site was located at 30% of the length between the popliteal fossa and lateral malleolus, where cross-sectional areas of the gastrocnemius are almost maximum. LG stiffness was measured at one-third of the length between the small head of the fibula and the heel (Masood et al., 2014). stiffness measurements were performed when participants were in a prone position with the knee joint fully extended and the hip in the neutral position.The probe of the Myoton3 was placed perpendicular to the surface of the soft tissue for the stiffness measurement.
2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Achilles tendon resting angle (ATRA)
Time Frame: 2 year
The ATRA test assesses ankle mobility with a goniometer, using one arm along the fibula shaft and the other on the fifth metatarsal head. In the heel-rise test, subjects stand on one foot on a 15-cm high box, measuring the distance between the heel and the step as they raise it as high as possible. This is averaged over three trials.
2 year
Heel rise test
Time Frame: 2 year
During heel-rise test performance subjects stood on one foot on a 15-cmhigh, flat box . Ameasuring tape determined the distance between the plantar surface of the heel and the top of the step as subjects attempted to raise their heel as high as possible and hold this position for 5 seconds. The bony calcaneal prominence where the central Achilles tendon made insertion was palpated to confirm the tape measure placement point. Three test trials were performed, and the average distance was determined.
2 year
WBLT (weight bearing lunge test)
Time Frame: 2 year
Closed kinetic chain ankle dorsiflexion movement magnitude was measured using the WBLT. During WBLT performance, subjects stood barefoot, facing a wall with the test foot parallel to a tape measure placed on the floor. While in this position the opposite foot was placed approximately 1 foot length behind the test foot while maintaining test foot and knee perpendicular alignment with the wall. Subjects performed an anterior lunge with the goal of lightly touching their patella to the wall while keeping their heel firmly planted on the floor. While in this position, the test foot was progressively moved away from the wall in approximately 1-cm intervals, and the test was repeated. This process continued until heel contact could no longer be maintained. At this point, the distance between the distal big toe and the wall was measured.
2 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hande Güney Deniz, Proffessor, Hacettepe University Faculty of Physical Therapy and Rehabilitation

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Achilles2023

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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