ParaplegiaNCT05483764
Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients.
An observational study of Paraplegia, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Investigators aim to measure the ankle talar cartilage and achilles tendon thicknesses ultrasonographically in paraplegic patients and compare them with the normal population. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Paraplegia
- What is being tested?
- Ultrasonographic evaluations
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 30 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The control group will be composed of healthy individuals who are compatible with the patient group in terms of age, gender and weight.
Who may be able to join
- Patients who are paraplegic after traumatic spinal cord injury (ASIA A-D)
- Healthy volunteers older than 18 years for control patients.
Who cannot join
- Patients who had a previous trauma-related operation on the ankle.
- Patients who had fixed contracture or severe spasticity on the ankle.
- Patients who had lower-limb length difference of more than 2 cm.
Trial locations and contacts
1 site in 1 country.
About this study
Investigators aim to measure the ankle talar cartilage and achilles tendon thicknesses ultrasonographically in paraplegic patients and compare them with the normal population.
Read the detailed description
Paraplegia is a clinical condition that expresses the loss of motor and sensory function in the lower extremities after spinal cord injury. A specialized and intensive rehabilitation program is needed in these patient groups who develop immobilization. In healthy individuals, there is a certain biomechanics of the lower extremity. In paraplegic patients, this biomechanics changes due to weakness in the lower extremities. These biomechanical changes can cause different loads and effects on the lower extremity joints, muscles, tendons, and articular cartilages of paraplegic patients. Among the rehabilitation goals of paraplegic patients, it is to stand up and walk the patient with or without support, with or without a device. During this rehabilitation, the position and function of the ankle is important. In this process, the talar condylar cartilage and achilles tendon forming the ankle joint can be exposed to different loads.
Ultrasonography is frequently used in physical therapy practice because it does not contain any radiation, has no side effects to the patient, facilitates dynamic and real-time evaluation of joint and muscle conditions and functions, and provides guidance during interventional procedure planning. In this study, investigators aim to ultrasonographically measure ankle talar cartilage and Achilles tendon thicknesses in paraplegic patients with long-term immobilization and compare them with the normal population.
Our study will be organized as a observational study. It is planned to include 20 paraplegia patients and 20 healthy volunteers in the study.
Demographic data of the patients and healthy volunteers will be recorded. Paraplegia patients will be evaluated in terms of Barthel Index, Modified Ashworth Scale, American Spinal Injury Association (ASIA) scale, Walking Index for Spinal Cord Injury Scale (WISCII-2).
- Conditions
- Paraplegia
- Being tested
- Ultrasonographic evaluations
- Medical subject headings
- Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic evaluationsDevice
Ultrasonographic evaluations of the talar cartilage will be performed with an 8 MHz linear probe (B-K Medical Ultrasound Scanner Class I Type B) by the same physiatrist according to the European Musculoskeletal Ultrasound Study Group (EURO-MUSCULUS).
Ultrasonographic evaluations of the Achilles tendon will be performed by the same physiatrist with an 8 MHz linear probe (B-K Medical Ultrasound Scanner Class I Type B) according to the European Musculoskeletal Ultrasound Study Group (EURO-MUSCULUS).
| Study group | Role | What they receive |
|---|---|---|
| Paraplegia | Not described Receives: Device: Ultrasonographic evaluations | |
| Control | Not described Receives: Device: Ultrasonographic evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle talar cartilage thicknesses
Patients will lie on the examination table supine with their knees flexed to 90 degrees and ankles in a flat-footed position. The probe was placed mid-longitudinally over the ankle joint to assess the cartilage of the talar dome. The articular cartilage will be displayed as an anechoic line between bony cortex and adipose tissue. Cartilage thickness will be measured by drawing a straight line from the bone-cartilage interface to the cartilage-fatty tissue interface at the midpoint of the talar dome. The thickness of the hyaline cartilage will be measured in centimeters (cm).
Measured: 1 day
Achilles tendon thicknesses
Ultrasound (US) evaluation will be performed with patients in the prone position on examination table with their feet in 90 degrees of flexion. Achilles tendon of the each patient and healthy volunteer will be scanned.
Antero-posterior achilles thickness will be measured on the same mid-longitudinally scan at two different levels: at the insertion of the achilles tendon deeper edge into the calcaneal bone and 3 cm more proximal. The thickness of the achilles tendon will be measured in centimeters (cm).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Aug 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaplegiaStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483764
- Sponsor's protocol ID
- AIBU-FTR-SK-03
- Status last verified
- Feb 2025
- First submitted
- 28 Jul 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients.
- ClinicalTrials.gov ID
- NCT05483764
- Acronym / sponsor ID
- AIBU-FTR-SK-03
- Conditions
- Paraplegia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 2 Aug 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.
Investigators aim to measure the ankle talar cartilage and achilles tendon thicknesses ultrasonographically in paraplegic patients and compare them with the normal population.
Detailed description
Paraplegia is a clinical condition that expresses the loss of motor and sensory function in the lower extremities after spinal cord injury. A specialized and intensive rehabilitation program is needed in these patient groups who develop immobilization. In healthy individuals, there is a certain biomechanics of the lower extremity. In paraplegic patients, this biomechanics changes due to weakness in the lower extremities. These biomechanical changes can cause different loads and effects on the lower extremity joints, muscles, tendons, and articular cartilages of paraplegic patients. Among the rehabilitation goals of paraplegic patients, it is to stand up and walk the patient with or without support, with or without a device. During this rehabilitation, the position and function of the ankle is important. In this process, the talar condylar cartilage and achilles tendon forming the ankle joint can be exposed to different loads.
Ultrasonography is frequently used in physical therapy practice because it does not contain any radiation, has no side effects to the patient, facilitates dynamic and real-time evaluation of joint and muscle conditions and functions, and provides guidance during interventional procedure planning. In this study, investigators aim to ultrasonographically measure ankle talar cartilage and Achilles tendon thicknesses in paraplegic patients with long-term immobilization and compare them with the normal population.
Our study will be organized as a observational study. It is planned to include 20 paraplegia patients and 20 healthy volunteers in the study.
Demographic data of the patients and healthy volunteers will be recorded. Paraplegia patients will be evaluated in terms of Barthel Index, Modified Ashworth Scale, American Spinal Injury Association (ASIA) scale, Walking Index for Spinal Cord Injury Scale (WISCII-2).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paraplegia | – | Device: Ultrasonographic evaluations |
| Control | – | Device: Ultrasonographic evaluations |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The control group will be composed of healthy individuals who are compatible with the patient group in terms of age, gender and weight.
Key inclusion criteria (2 listed)
- Patients who are paraplegic after traumatic spinal cord injury (ASIA A-D)
- Healthy volunteers older than 18 years for control patients.
Key exclusion criteria (3 listed)
- Patients who had a previous trauma-related operation on the ankle.
- Patients who had fixed contracture or severe spasticity on the ankle.
- Patients who had lower-limb length difference of more than 2 cm.
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 |
|---|---|---|
| Ultrasonographic evaluationsUltrasonographic evaluations of the talar cartilage will be performed with an 8 MHz linear probe (B-K Medical Ultrasound Scanner Class I Type B) by the same physiatrist according to the European Musculoskeletal Ultrasound Study Group (EURO-MUSCULUS). Ultrasonographic evaluations of the Achilles tendon will be performed by the same physiatrist with an 8 MHz linear probe (B-K Medical Ultrasound Scanner Class I Type B) according to the European Musculoskeletal Ultrasound Study Group (EURO-MUSCULUS). | Device | Control, Paraplegia |
Primary outcome
Ankle talar cartilage thicknesses
Time frame: 1 day
Patients will lie on the examination table supine with their knees flexed to 90 degrees and ankles in a flat-footed position. The probe was placed mid-longitudinally over the ankle joint to assess the cartilage of the talar dome. The articular cartilage will be displayed as an anechoic line between bony cortex and adipose tissue. Cartilage thickness will be measured by drawing a straight line from the bone-cartilage interface to the cartilage-fatty tissue interface at the midpoint of the talar dome. The thickness of the hyaline cartilage will be measured in centimeters (cm).
Achilles tendon thicknesses
Time frame: 1 day
Ultrasound (US) evaluation will be performed with patients in the prone position on examination table with their feet in 90 degrees of flexion. Achilles tendon of the each patient and healthy volunteer will be scanned. Antero-posterior achilles thickness will be measured on the same mid-longitudinally scan at two different levels: at the insertion of the achilles tendon deeper edge into the calcaneal bone and 3 cm more proximal. The thickness of the achilles tendon will be measured in centimeters (cm).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Related trials for Paraplegia
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Active, not recruiting
Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
RecruitingPhase 2/3
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Spinal Cord Injury, Traumatic Spinal Cord Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Paraplegia, run by Abant Izzet Baysal 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Ankle talar cartilage thicknesses (time frame: 1 day). The study lists 2 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 26 Feb 2025.