Amputation, TraumaticNCT04262297
Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users
An observational study of Amputation, Traumatic, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Amputation, Traumatic
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 May 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Prosthesis users with transtibial amputation and their age-, sex- and dominancy-matched (1:1) able-bodied controls to provide an amputation-independent reference were included.
Who may be able to join
- Unilateral transtibial amputation on the right side
- Using the prosthesis for more than 1 year
- Able to use the prosthesis without pain and discomfort
- Able to walk without a walking aid
Who cannot join
- Presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.)
- Ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.)
- Taking medication that is known to affect balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Ultrasonographic Rectus Femoris Thickness Measurement and Functionality in Unilateral Transtibial Amputated Prosthesis Users
Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. Therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process. Muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy X-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases. The first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests. The second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial amputation.
Read the detailed description
Bilateral rectus femoris muscle thickness was measured by two independent examiners using an ultrasound. Bilateral knee extension strength was measured via handheld dynamometer (Jamar, Bolingbrook, IL, USA). Functional strength and walking were assessed by Step-up-over (SUO) and Walk-across (WA) tests of NeuroCom Balance Master® device (NeuroCom International, Clackamas, OR, USA).
- Conditions
- Amputation, Traumatic
- Keywords
- Amputees, Quadriceps MuscleMuscle Strength, Muscle Strength
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis users | Prosthesis users with transtibial amputation | |
| Able-bodied Controls | Prosthesis users' age-, sex- and dominancy-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic cross-sectional area of rectus femoris measurement
Images were obtained at the bulkiest area of muscle at mid-thigh (midway between the anterior superior iliac spine and the upper pole of the patella) while the participant lay in the supine position with lower limbs are extended and relaxed. The probe was held axially with a light touch in order not to cause any difference in the muscle volume. The rectus femoris cross-sectional area of both limbs (CSA-RF) (mm2) was calculated.
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Knee extension strength measurement via handheld dynamometer
The dynamometer was located 5 cm above the intermalleolar line to measure bilateral knee extension strength. All participants were tested while lying supine position with a support behind the knees to achieve approximately 30° of flexion. For the amputated-limb, the prosthesis was used in place.
Measured: through study completion, an average of 6 months
Step-up-over Test
All participants were asked to stand still behind the box placed on the pressure platform and to move immediately after seeing the sign on the computer screen. The movement was defined as three phases: first stepping onto the box with one limb, second carrying the body over the box, and third landing with the other limb on the opposite side of the box. The average lift-up index (%), movement time (s), and the impact index for both limbs calculated after three repetitions.
Measured: through study completion, an average of 6 months
Walk-across Test
All participants were asked to stand still and to walk as fast as possible along with the pressure platform after seeing the sign on the computer screen. The average step width (cm), step length (cm), and speed (cm/s) were calculated after three repetitions.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 May 2019
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.
- More trials run by Marmara 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen Gencer Atalay, Marmara University
- Investigators
- Kardelen Gencer Atalay, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262297
- Sponsor's protocol ID
- 09.2018.025
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 10 Feb 2020
- 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 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Ultrasonographic Rectus Femoris Thickness Measurement and Functionality in Unilateral Transtibial Amputated Prosthesis Users
- ClinicalTrials.gov ID
- NCT04262297
- Acronym / sponsor ID
- 09.2018.025
- Conditions
- Amputation, Traumatic
- Keywords
- Amputees, Quadriceps MuscleMuscle Strength, Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 10 Feb 2020 (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.
Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. Therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process. Muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy X-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases. The first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests. The second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial amputation.
Detailed description
Bilateral rectus femoris muscle thickness was measured by two independent examiners using an ultrasound. Bilateral knee extension strength was measured via handheld dynamometer (Jamar, Bolingbrook, IL, USA). Functional strength and walking were assessed by Step-up-over (SUO) and Walk-across (WA) tests of NeuroCom Balance Master® device (NeuroCom International, Clackamas, OR, USA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosthesis users | – | –Prosthesis users with transtibial amputation |
| Able-bodied Controls | – | –Prosthesis users' age-, sex- and dominancy-matched healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prosthesis users with transtibial amputation and their age-, sex- and dominancy-matched (1:1) able-bodied controls to provide an amputation-independent reference were included.
Key inclusion criteria (4 listed)
- Unilateral transtibial amputation on the right side
- Using the prosthesis for more than 1 year
- Able to use the prosthesis without pain and discomfort
- Able to walk without a walking aid
Key exclusion criteria (3 listed)
- Presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.)
- Ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.)
- Taking medication that is known to affect balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasonographic cross-sectional area of rectus femoris measurement
Time frame: through study completion, an average of 6 months
Images were obtained at the bulkiest area of muscle at mid-thigh (midway between the anterior superior iliac spine and the upper pole of the patella) while the participant lay in the supine position with lower limbs are extended and relaxed. The probe was held axially with a light touch in order not to cause any difference in the muscle volume. The rectus femoris cross-sectional area of both limbs (CSA-RF) (mm2) was calculated.
3 secondary outcomes
Knee extension strength measurement via handheld dynamometer
Time frame: through study completion, an average of 6 months
Step-up-over Test
Time frame: through study completion, an average of 6 months
Walk-across Test
Time frame: through study completion, an average of 6 months
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 10 Feb 2020.
- 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.
Kardelen Gencer Atalay principal investigator
Marmara 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 Amputation, Traumatic, run by Marmara 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 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: finished, as of the sponsor's last update on 10 Feb 2020. 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?
Ultrasonographic cross-sectional area of rectus femoris measurement (time frame: through study completion, an average of 6 months). 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 10 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.