Amputation, TraumaticNCT05827744
The Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles
An observational study of Amputation, Traumatic, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Amputation, Traumatic
- What is being tested?
- Isokinetic evaluations and Ultrasonographic evaluations
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Dec 2023
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 27 patients with unilateral transfemoral amputation
Who may be able to join
- Aged between 18-65
- The time elapsed after amputation > 6 months
- Using prosthesis for at least 3 months
- Being able to walk without an assistive device
Who cannot join
- Bilateral lower extremity amputation
- Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
Merve Örücü Atar
About this study
Official title: The Evaluation of the Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles in Patients With Unilateral Traumatic Transfemoral Amputation
The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.
Read the detailed description
The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.
This study will be useful in understanding whether ultrasonography is an appropriate imaging method in the follow-up of changes in functional strength in the hip girdle in patients with unilateral traumatic transfemoral amputation.
- Conditions
- Amputation, Traumatic
- Being tested
- Isokinetic evaluations, Ultrasonographic evaluations
- Keywords
- amputation, hip flexors, hip extensors
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic evaluationsOther
Peak torque and total amount of work of hip flexors and extensors will be determined by the Cybex 6000 model computer-aided isokinetic system.
Ultrasonographic evaluationsOther
Ultrasonographic evaluations will be performed with a 5-12 MHz linear probe (Logic e portable; GE Healthcare, China). The thicknesses of the hip flexor (psoas major) and extensor (gluteus maximus) muscles will be measured while the patient is in the prone position, in accordance with the literature.
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking test (6MWT)
Functional performance will be assessed by 6MWT (in meter). Patients will be instructed to walk quickly, safely, and as much distance as possible over a rectangular path.
Measured: through study completion, an average of one month
10-meter walking test
The short-distance over-ground gait speed will be assessed using a 10-Meter Walk Test. Participants will be asked to walk at normal pace on a 10-meter walkway.
Measured: through study completion, an average of one month
Timed up and go test
Timed up and go test will be used for quantifying functional mobility balance. Participants will be instructed to sit in a comfortable position on a 45-65 cm high steady chair with a backrest and armrest, with both arms resting on their thighs, and then quickly stand up and move towards and around a fixed cone 3 m away, return, and sit again.
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 May 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Merve Örücü Atar, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827744
- Sponsor's protocol ID
- 36
- Status last verified
- Oct 2023
- First submitted
- 12 Apr 2023
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles in Patients With Unilateral Traumatic Transfemoral Amputation
- ClinicalTrials.gov ID
- NCT05827744
- Acronym / sponsor ID
- 36
- Conditions
- Amputation, Traumatic
- Keywords
- amputation, hip flexors, hip extensors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 25 Apr 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.
The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.
Detailed description
The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.
This study will be useful in understanding whether ultrasonography is an appropriate imaging method in the follow-up of changes in functional strength in the hip girdle in patients with unilateral traumatic transfemoral amputation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 27 patients with unilateral transfemoral amputation
Key inclusion criteria (4 listed)
- Aged between 18-65
- The time elapsed after amputation > 6 months
- Using prosthesis for at least 3 months
- Being able to walk without an assistive device
Key exclusion criteria (2 listed)
- Bilateral lower extremity amputation
- Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
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 |
|---|---|---|
| Isokinetic evaluationsPeak torque and total amount of work of hip flexors and extensors will be determined by the Cybex 6000 model computer-aided isokinetic system. | Other | – |
| Ultrasonographic evaluationsUltrasonographic evaluations will be performed with a 5-12 MHz linear probe (Logic e portable; GE Healthcare, China). The thicknesses of the hip flexor (psoas major) and extensor (gluteus maximus) muscles will be measured while the patient is in the prone position, in accordance with the literature. | Other | – |
Primary outcome
6-minute walking test (6MWT)
Time frame: through study completion, an average of one month
Functional performance will be assessed by 6MWT (in meter). Patients will be instructed to walk quickly, safely, and as much distance as possible over a rectangular path.
10-meter walking test
Time frame: through study completion, an average of one month
The short-distance over-ground gait speed will be assessed using a 10-Meter Walk Test. Participants will be asked to walk at normal pace on a 10-meter walkway.
Timed up and go test
Time frame: through study completion, an average of one month
Timed up and go test will be used for quantifying functional mobility balance. Participants will be instructed to sit in a comfortable position on a 45-65 cm high steady chair with a backrest and armrest, with both arms resting on their thighs, and then quickly stand up and move towards and around a fixed cone 3 m away, return, and sit again.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
Merve Örücü Atar principal investigator
assistant professor
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 Amputation, Traumatic, run by Gaziler Physical Medicine and Rehabilitation Education and Research 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 4 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 23 Oct 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 Merve Örücü Atar, MD (03122912443, drmerveorucu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking test (6MWT) (time frame: through study completion, an average of one month). 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 23 Oct 2023.