- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112288
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
20
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
- Name: Fırat Tan, MSc
- Phone Number: +905462105071
- Email: fztfirattan@gmail.com
Study Contact Backup
- Name: Fırat Tan
- Phone Number: +905462105071
- Email: fztfirattan@gmail.com
Study Locations
-
-
Eyalet/Yerleşke
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Ankara, Eyalet/Yerleşke, Turkey, 06100
- Recruiting
- Fırat Tan
-
Contact:
- Fırat Tan
- Phone Number: +905462105071
- Email: firattan01@icloud.com
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
ankle mobilization is manual therapy technics.
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
April 26, 2023
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
September 29, 2023
First Submitted That Met QC Criteria
October 30, 2023
First Posted (Actual)
November 1, 2023
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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