Achilles Tendon RuptureNCT06112288
The Acute Effect Comparisons of Manual Therapy Or Ankle Motion in Individuals Who Had Achilles Tendon Repair
A study testing Compressive Myofascial Release and Ankle mobilisation in people with Achilles Tendon Rupture and Functional Performance, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Achilles Tendon Rupture, Functional Performance
- What is being tested?
- Compressive Myofascial Release and Ankle mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fırat Tan
Ankara, Eyalet/Yerleşke, 06100
Fırat Tan, +905462105071, firattan01@icloud.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Achilles Tendon Rupture, Functional Performance
- Being tested
- Compressive Myofascial Release, Ankle mobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressive Myofascial ReleaseOther
Compressive myofascial release is manual therapy technics.
Ankle mobilisationOther
ankle mobilization is manual therapy technics.
| Study group | Role | What they receive |
|---|---|---|
| Compressive myofascial release (cmr) | Experimental | 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. Receives: Other: Compressive Myofascial Release |
| ankle mobilization | Experimental | 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 Receives: Other: Ankle mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive Mechanical Properties
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.
Measured: 2 year
Secondary outcomes (3)
Achilles tendon resting angle (ATRA)
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.
Measured: 2 year
Heel rise test
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.
Measured: 2 year
WBLT (weight bearing lunge test)
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start26 Apr 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fırat Tan, Hacettepe University
- Investigators
- Hande Güney Deniz, Proffessor, Study director, Hacettepe University Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112288
- Sponsor's protocol ID
- Achilles2023
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06112288
- Acronym / sponsor ID
- Achilles2023
- Conditions
- Achilles Tendon Rupture, Functional Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compressive myofascial release (cmr) | Experimental | Other: Compressive Myofascial ReleaseParticipants 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. |
| ankle mobilization | Experimental | Other: Ankle mobilisationThe 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Being male between the ages of 18-55,
Key exclusion criteria (6 listed)
- • Presence of a history of repeated Achilles tendon rupture,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compressive Myofascial ReleaseCompressive myofascial release is manual therapy technics. | Other | Compressive myofascial release (cmr) |
| Ankle mobilisationankle mobilization is manual therapy technics. | Other | ankle mobilization |
Primary outcome
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.
3 secondary outcomes
Achilles tendon resting angle (ATRA)
Time frame: 2 year
Heel rise test
Time frame: 2 year
WBLT (weight bearing lunge test)
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hande Güney Deniz, Proffessor study director
Hacettepe University Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compressive Myofascial Release and Ankle mobilisation in people with Achilles Tendon Rupture and Functional Performance, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fırat Tan, MSc (+905462105071, fztfirattan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive Mechanical Properties (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.