AmputationNCT05597696
Sitting Balance in Lower Limb Amputees
An observational study of Amputation and Traumatic Amputation of Lower Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Traumatic Amputation of Lower Extremity
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Jul 2023
- How long will I take part?
- 1 Day
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.
Who may be able to join
- Unilateral transfemoral amputation
- Using their prosthesis for at least 6 months
Who cannot join
- congenital amputee
- Bilateral lower extremity amputation
- Central or peripheral vestibular disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation
Ankara, Samanpazarı, 06100
About this study
Official title: Evaluation of Sitting Balance in Lower Limb Amputees: a Case Control Study
The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.
Read the detailed description
Postural stability is important for amputees to perform daily life activities and participate in social activities. The aim of this study is to compare the sitting and standing stability of transfemoral individuals with healthy individuals with similar demographic characteristics. A force platform was used to measure the postural stability of individuals. The sitting limits of stability of the participants were recorded in cm. Amputees between the ages of 18-50, using their prosthesis for at least 6 months, and healthy individuals with similar demographic characteristics were included in the study. Congenital amputees, individuals with bilateral lower extremity amputations, and individuals with central or peripheral vestibular disorders were excluded. Our study will reveal the importance of sitting stability limits in the evaluation and treatment of amputees.
- Keywords
- Limits of stability, Sitting balance, Standing balance
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 |
|---|---|---|
| 1) Experimental Group: Transfemoral Amputee | Balance assessment in sitting | |
| 2) Control Group: Healthy Subjects | Balance assessment in sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of stability
Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements in sitting. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 May 2022
- Primary completion31 Dec 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Karakaş, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597696
- Sponsor's protocol ID
- GO 22-385
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sitting Balance in Lower Limb Amputees: a Case Control Study
- ClinicalTrials.gov ID
- NCT05597696
- Acronym / sponsor ID
- GO 22-385
- Keywords
- Limits of stability, Sitting balance, Standing balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 28 Oct 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.
The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.
Detailed description
Postural stability is important for amputees to perform daily life activities and participate in social activities. The aim of this study is to compare the sitting and standing stability of transfemoral individuals with healthy individuals with similar demographic characteristics. A force platform was used to measure the postural stability of individuals. The sitting limits of stability of the participants were recorded in cm. Amputees between the ages of 18-50, using their prosthesis for at least 6 months, and healthy individuals with similar demographic characteristics were included in the study. Congenital amputees, individuals with bilateral lower extremity amputations, and individuals with central or peripheral vestibular disorders were excluded. Our study will reveal the importance of sitting stability limits in the evaluation and treatment of amputees.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) Experimental Group: Transfemoral Amputee | – | –Balance assessment in sitting |
| 2) Control Group: Healthy Subjects | – | –Balance assessment in sitting |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.
Key inclusion criteria (2 listed)
- Unilateral transfemoral amputation
- Using their prosthesis for at least 6 months
Key exclusion criteria (3 listed)
- congenital amputee
- Bilateral lower extremity amputation
- Central or peripheral vestibular disorders
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
Limits of stability
Time frame: 15 minutes
Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements in sitting. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance.
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 12 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.
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 Amputation and Traumatic Amputation of Lower Extremity, run by Hacettepe 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: finished, as of the sponsor's last update on 12 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?
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?
Limits of stability (time frame: 15 minutes). 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 12 Oct 2023; AzTrials last refreshed its copy on 31 Oct 2026.