SarcopeniaNCT04042818
Reliability of Rehabilitative Ultrasound for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
An observational study of Sarcopenia and Stroke, Complication, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia, Stroke, Complication, Quadriceps Muscle Atrophy
- What is being tested?
- Rehabilitative Ultrasound
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Poststroke patients
Who may be able to join
- Poststroke patients (>6 months)
Who cannot join
- < 6 months after stroke
- Multiple stroke
Trial locations and contacts
1 site in 1 country.
Zeynel Karakullukçuoğlu, M.D. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Taksim Training and Research Hospital
Istanbul, 34255
Mehmet Akif Guler, 5054930098, makifguler89@gmail.com
About this study
Official title: Reliability of Rehabilitative Ultrasound Imaging for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
The purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients.
Read the detailed description
Poststroke patients often suffer from muscle atrophy in quadriceps muscle. Quadriceps muscle is essential for independent standing or ambulation after stroke. Quadriceps muscle consists of four different muscles: rectus femoris, vastus intermedius, vastus lateralis and medialis. The present study search for reliability for rectus femoris and vastus intermedius muscle thickness and cross-sectional area using rehabilitative ultrasound imagining. Longitudinal and transverse ultrasound imagining of the muscle thickness will be performed on both rectus femoris and vastus intermedius muscles for both extremities. The procedures will be repeated by two experts at two separate times (7-10 days). For sarcopenia measurement grip strength and DEXA measurements of the patients will be calculated. Totally 68 patients will be included in the study.
- Conditions
- Sarcopenia, Stroke, Complication, Quadriceps Muscle Atrophy, Hemiplegia, Ultrasonography, Hand Strength
- Being tested
- Rehabilitative Ultrasound
- Keywords
- Sarcopenia, Stroke, Quadriceps Muscle Atrophy, Hemiplegia, Ultrasonography, Hand Strength
- Medical subject headings
- Sarcopenia, Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitative UltrasoundDiagnostic test
Ultrasound imagining
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of Rectus Femoris Muscle
Longitudinal and Transverse thickness of rectus femoris muscle
Measured: One week
Thickness of vastus intermedius muscle
Longitudinal and Transverse thickness of vastus intermedius muscle
Measured: One week
Cross-sectional area of Rectus Femoris Muscle
Cross-sectional area of Rectus Femoris Muscle
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
- Investigators
- Ebru Y Yalçınkaya, M.D., Study director, Gaziosmanpasa Taksim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042818
- Sponsor's protocol ID
- GaziosmanpasaTREH7
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2019
- Last updated
- 2 Aug 2019
- 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 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Rehabilitative Ultrasound Imaging for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
- ClinicalTrials.gov ID
- NCT04042818
- Acronym / sponsor ID
- GaziosmanpasaTREH7
- Conditions
- Sarcopenia, Stroke, Complication, Quadriceps Muscle Atrophy, Hemiplegia, Ultrasonography, Hand Strength
- Keywords
- Sarcopenia, Stroke, Quadriceps Muscle Atrophy, Hemiplegia, Ultrasonography, Hand Strength
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 2 Aug 2019 (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 purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients.
Detailed description
Poststroke patients often suffer from muscle atrophy in quadriceps muscle. Quadriceps muscle is essential for independent standing or ambulation after stroke. Quadriceps muscle consists of four different muscles: rectus femoris, vastus intermedius, vastus lateralis and medialis. The present study search for reliability for rectus femoris and vastus intermedius muscle thickness and cross-sectional area using rehabilitative ultrasound imagining. Longitudinal and transverse ultrasound imagining of the muscle thickness will be performed on both rectus femoris and vastus intermedius muscles for both extremities. The procedures will be repeated by two experts at two separate times (7-10 days). For sarcopenia measurement grip strength and DEXA measurements of the patients will be calculated. Totally 68 patients will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Poststroke patients
Key inclusion criteria (1 listed)
- Poststroke patients (>6 months)
Key exclusion criteria (2 listed)
- < 6 months after stroke
- Multiple stroke
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 |
|---|---|---|
| Rehabilitative UltrasoundUltrasound imagining | Diagnostic test | – |
Primary outcome
Thickness of Rectus Femoris Muscle
Time frame: One week
Longitudinal and Transverse thickness of rectus femoris muscle
Thickness of vastus intermedius muscle
Time frame: One week
Longitudinal and Transverse thickness of vastus intermedius muscle
Cross-sectional area of Rectus Femoris Muscle
Time frame: One week
Cross-sectional area of Rectus Femoris Muscle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- 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.
Zeynel Karakullukçuoğlu, M.D. contact
Ebru Y Yalçınkaya, M.D. study director
Gaziosmanpasa Taksim Training and Research Hospital
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 Sarcopenia and Stroke, Complication, run by Gaziosmanpasa Research and Education Hospital 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 1 inclusion and 2 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 2 Aug 2019. 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 Mehmet A Guler, M.D. (+905054930098, makifguler89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of Rectus Femoris Muscle (time frame: One week). 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 2 Aug 2019.