Amputation, TraumaticNCT05435326
The Relationship of Stump Length With Muscle Strength in Patients With Traumatic Unilateral Transfemoral Amputation
An observational study of Amputation, Traumatic, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
Trial summary
Amputation is the loss or removal of a body part such as an arm or leg. It is the last option in trauma treatment and irreversible procedure. Amputation rehabilitation begins in the pre-amputation period. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Amputation, Traumatic
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 18 Jul 2022to 15 Sep 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-65 who underwent traumatic amputation at least 6 months ago will participate in the study.
Who may be able to join
- Age between 18-65 years
- Time after amputation ≥ 6 months
- Unilateral transfemoral traumatic amputation
Who cannot join
- Bilateral transfemoral amputation
- Unilateral non-traumatic transfemoral amputation
- Presence of neurological, auditory, or vision-related disease that may affect balance and proprioception
- Presence of cardiovascular or pulmonary disease that will affect muscle strength
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Relationship of Stump Length With Muscle Strength, Balance, and Proprioception in Patients With Traumatic Unilateral Transfemoral Amputation
Amputation is the loss or removal of a body part such as an arm or leg. It is the last option in trauma treatment and irreversible procedure. Amputation rehabilitation begins in the pre-amputation period. The goal of rehabilitation after an amputation is to help the patient return to the highest level of function and independence possible, while improving the overall quality of life. Many factors can affect the success of lower limb amputation rehabilitation, and stump length is one of them. A sufficient stump length provides a large contact surface and increases the stability of the socket unit.
Read the detailed description
Amputation is the loss or removal of a body part such as an arm or leg. It is the last option in trauma treatment and irreversible procedure. Amputation rehabilitation begins in the pre-amputation period. The goal of rehabilitation after an amputation is to help the patient return to the highest level of function and independence possible, while improving the overall quality of life. Many factors can affect the success of lower limb amputation rehabilitation, and stump length is one of them. A sufficient stump length provides a large contact surface and increases the stability of the socket unit.
People with unilateral transfemoral amputation have lost their knee and ankle joint.
This causes a loss of proprioceptive feedback from the ankle joint, knee joint and related muscles. Muscle weakness, muscle atrophy and balance problems are common in amputee patients.
There is not enough data to reveal the relationship between stump length and muscle strength, balance, and proprioception. The aim of this study to evaluate the relationship of stump length with muscle strength, balance, and proprioception in patients with traumatic unilateral transfemoral amputation.
- Conditions
- Amputation, Traumatic
- Keywords
- amputation, stump length, muscle strength, balance, proprioception
- Medical subject headings
- Amputation, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
The isokinetic muscle strength of the hip extensors and flexors
The isokinetic muscle strength of the hip extensors and flexors will be measured with the computer -assisted isokinetic system (CYBEX). The tests were performed at the angular velocities of 60° and 120°/s, while measuring flexion and extension of the amputated side.
Measured: through study completion, an average of one month
Secondary outcomes (2)
The Berg Balance Scale (BBS)
The balance will be evaluated using the Berg Balance Scale (BBS). The BBS is a clinical test commonly used to assess the patients' static and dynamic balance performance. Berg Balance Scale consist of 14 items. A participant's performance on each task is graded using a 5-point ordinal scale ranging from 0 to 4. Total score of scale is 0-56 points. The higher the scores show the better the balance ability of the patients.
Measured: through study completion, an average of one month
Proprioception assessment
The computer-assisted isokinetic system (CYBEX) will be also used to evaluate the lower extremity proprioceptive sense of patients. The average proprioceptive errors at 15-45° and 30-60° were assessed. Patients will be taught the initial 15° and the targeted 45° hip flexion angles by keeping hip in these angles for 10 seconds. Afterwards, patients will be asked to move from the initial 15° to the target 45° while their eyes are closed. The average proprioceptive errors which are deviations from target angles will be noted. The same procedure will be done for initial 30° and target 60° angles.
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 posted28 Jun 2022
- Study start18 Jul 2022 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 16 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
- Gizem Kılınç Kamacı, MD, Principal investigator, Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435326
- Sponsor's protocol ID
- 28
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kilinc Kamaci G, Orucu Atar M, Ozcan F, Demir Y, Aydemir K. Relationship of stump length with muscle strength, proprioception, and balance in patients with traumatic unilateral transfemoral amputation. Prosthet Orthot Int. 2024 Dec 18;49(3):268-273. doi: 10.1097/PXR.0000000000000385.
PubMed 39692742
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Stump Length With Muscle Strength, Balance, and Proprioception in Patients With Traumatic Unilateral Transfemoral Amputation
- ClinicalTrials.gov ID
- NCT05435326
- Acronym / sponsor ID
- 28
- Conditions
- Amputation, Traumatic
- Keywords
- amputation, stump length, muscle strength, balance, proprioception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 18 Jul 2022 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 28 Jun 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.
Amputation is the loss or removal of a body part such as an arm or leg. It is the last option in trauma treatment and irreversible procedure. Amputation rehabilitation begins in the pre-amputation period. The goal of rehabilitation after an amputation is to help the patient return to the highest level of function and independence possible, while improving the overall quality of life. Many factors can affect the success of lower limb amputation rehabilitation, and stump length is one of them. A sufficient stump length provides a large contact surface and increases the stability of the socket unit.
Detailed description
Amputation is the loss or removal of a body part such as an arm or leg. It is the last option in trauma treatment and irreversible procedure. Amputation rehabilitation begins in the pre-amputation period. The goal of rehabilitation after an amputation is to help the patient return to the highest level of function and independence possible, while improving the overall quality of life. Many factors can affect the success of lower limb amputation rehabilitation, and stump length is one of them. A sufficient stump length provides a large contact surface and increases the stability of the socket unit.
People with unilateral transfemoral amputation have lost their knee and ankle joint.
This causes a loss of proprioceptive feedback from the ankle joint, knee joint and related muscles. Muscle weakness, muscle atrophy and balance problems are common in amputee patients.
There is not enough data to reveal the relationship between stump length and muscle strength, balance, and proprioception. The aim of this study to evaluate the relationship of stump length with muscle strength, balance, and proprioception in patients with traumatic unilateral 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
- Patients between the ages of 18-65 who underwent traumatic amputation at least 6 months ago will participate in the study.
Key inclusion criteria (3 listed)
- Age between 18-65 years
- Time after amputation ≥ 6 months
- Unilateral transfemoral traumatic amputation
Key exclusion criteria (4 listed)
- Bilateral transfemoral amputation
- Unilateral non-traumatic transfemoral amputation
- Presence of neurological, auditory, or vision-related disease that may affect balance and proprioception
- Presence of cardiovascular or pulmonary disease that will affect muscle strength
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
The isokinetic muscle strength of the hip extensors and flexors
Time frame: through study completion, an average of one month
The isokinetic muscle strength of the hip extensors and flexors will be measured with the computer -assisted isokinetic system (CYBEX). The tests were performed at the angular velocities of 60° and 120°/s, while measuring flexion and extension of the amputated side.
2 secondary outcomes
The Berg Balance Scale (BBS)
Time frame: through study completion, an average of one month
Proprioception assessment
Time frame: through study completion, an average of one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 39692742Kilinc Kamaci G, Orucu Atar M, Ozcan F, Demir Y, Aydemir K. Relationship of stump length with muscle strength, proprioception, and balance in patients with traumatic unilateral transfemoral amputation. Prosthet Orthot Int. 2024 Dec 18;49(3):268-273. doi: 10.1097/PXR.0000000000000385.
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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.
Gizem Kılınç Kamacı, MD principal investigator
Specialist
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.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Gizem Kılınç Kamacı, MD (03122912413, kilinc_gizem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The isokinetic muscle strength of the hip extensors and flexors (time frame: through study completion, an average of one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435326, which also lists 1 linked publication.
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 28 Jun 2022.