DiabetesNCT05452551
Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties
An observational study of Diabetes and Diabetes Mellitus, run by İlke KARA, PT at 1 site in Turkey (Türkiye).
Trial summary
The study aims to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Plantar Fascia
- What is being tested?
- Myotonometric measurement
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2021to 1 Jun 2022
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults between 18-35 years old diagnosed with Type 2 Diabetes
Who may be able to join
- Age ≥ 18 years
- Body mass index < 30 kilogram/meter square
- Willing to participate in the study
- Diagnosed with Type 2 Diabetes
- HbA1c level ≥ 6.5% mmol/mol
- Fasting plasma glucose ≥126 mg/dl
- Random plasma glucose ≥ 200 mg/d
Who cannot join
- History of lower extremity injuries
- Ulceration localized on plantar fascia
- Age ≥ 65 years
- Any use of medication that will affect muscle tone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties in Individuals With Diabetes
The study aims to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.
Read the detailed description
Therefore, changes occur in standing weight-bearing points, loading zones, and gait biomechanics. The thickened plantar fascia increases the risk of developing diabetic foot with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in individuals with diabetes than in healthy individuals. The myotonometer studies showed that chronic diabetes history increases dynamic stiffness, which is one of the mechanical properties of the plantar fascia, and that as the severity of the disease increases, fascial stiffness also increases. The aim of the study is to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Plantar Fascia
- Being tested
- Myotonometric measurement
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myotonometric measurementOther
MyotonPRO is a non-invasive myotonometer used to evaluate the viscoelastic properties of soft tissues. Data collection will be carried out by three researchers experienced in the use of myotonometer. Before the evaluations, participant and repeated measurement information for both researchers will be recorded on the device. All assessments will be made bilaterally. The first researcher will perform two measurements 30 minutes apart from the measurement point standardized with MyotonPRO to evaluate the plantar mechanical properties. Then, the second researcher will take two measurements with MyotonPRO from the same point with 30 minutes intervals. One day later, the first researcher will measure again from the same reference point once.
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Tone (Hz)
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant. The oscillation frequency (Hz) represents the resting muscle tone.
Measured: Day 1
Stiffness (N/m)
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.
Measured: Day 1
Logarithmic decrement
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start6 Jul 2021
- Primary completion1 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- İlke KARA, PT
- Sponsor type
- University, hospital or other
- Collaborators
- Bitlis Eren University, Medipol University
- Responsible party
- Sponsor-investigator, İlke KARA, PT, Dokuz Eylul University
- Investigators
- Tülay Çevik Saldıran, PhD, Study director, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452551
- Sponsor's protocol ID
- BEU-IK-02
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2022
- Last updated
- 7 Apr 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties in Individuals With Diabetes
- ClinicalTrials.gov ID
- NCT05452551
- Acronym / sponsor ID
- BEU-IK-02
- Conditions
- Diabetes, Diabetes Mellitus, Plantar Fascia
- Keywords
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- İlke KARA, PTUniversity, hospital or other
- Collaborators
- Bitlis Eren University, Medipol University
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Jul 2022 (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.
The study aims to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.
Detailed description
Therefore, changes occur in standing weight-bearing points, loading zones, and gait biomechanics. The thickened plantar fascia increases the risk of developing diabetic foot with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in individuals with diabetes than in healthy individuals. The myotonometer studies showed that chronic diabetes history increases dynamic stiffness, which is one of the mechanical properties of the plantar fascia, and that as the severity of the disease increases, fascial stiffness also increases. The aim of the study is to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between 18-35 years old diagnosed with Type 2 Diabetes
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Body mass index < 30 kilogram/meter square
- Willing to participate in the study
- Diagnosed with Type 2 Diabetes
- HbA1c level ≥ 6.5% mmol/mol
Key exclusion criteria (4 listed)
- History of lower extremity injuries
- Ulceration localized on plantar fascia
- Age ≥ 65 years
- Any use of medication that will affect muscle tone
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 |
|---|---|---|
| Myotonometric measurementMyotonPRO is a non-invasive myotonometer used to evaluate the viscoelastic properties of soft tissues. Data collection will be carried out by three researchers experienced in the use of myotonometer. Before the evaluations, participant and repeated measurement information for both researchers will be recorded on the device. All assessments will be made bilaterally. The first researcher will perform two measurements 30 minutes apart from the measurement point standardized with MyotonPRO to evaluate the plantar mechanical properties. Then, the second researcher will take two measurements with MyotonPRO from the same point with 30 minutes intervals. One day later, the first researcher will measure again from the same reference point once. | Other | – |
Primary outcome
Muscle Tone (Hz)
Time frame: Day 1
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant. The oscillation frequency (Hz) represents the resting muscle tone.
Stiffness (N/m)
Time frame: Day 1
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.
Logarithmic decrement
Time frame: Day 1
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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.
Tülay Çevik Saldıran, PhD study director
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, run by İlke KARA, PT 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 7 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Tone (Hz) (time frame: Day 1). The study lists 3 primary outcomes in all. 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 7 Apr 2023.