AmputationNCT04276467
Development of the ICF Based Amputee Mobility Scale
An observational study of Amputation, run by Hacettepe University.
Trial summary
Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2021
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Lower Limb Amputee
Who may be able to join
- Unilateral and traumatic lower limb loss
- Prosthesis use for at least 6 months
Who cannot join
- Not speaking or understanding Turkish
- Not having cognitive skills to perform the tests
About this study
Official title: Development and Validation of the International Classification of Functioning Disability and Health (ICF) Based Amputee Mobility Scale
Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated.
- Conditions
- Amputation
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Minute Walk Test
Measured: 3 March 2021
Amputee Mobility Predictor
Measured: 3 March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
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 only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Ekinci, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276467
- Sponsor's protocol ID
- GO 19/773
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the International Classification of Functioning Disability and Health (ICF) Based Amputee Mobility Scale
- ClinicalTrials.gov ID
- NCT04276467
- Acronym / sponsor ID
- GO 19/773
- Conditions
- Amputation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 19 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.
Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Lower Limb Amputee
Key inclusion criteria (2 listed)
- Unilateral and traumatic lower limb loss
- Prosthesis use for at least 6 months
Key exclusion criteria (2 listed)
- Not speaking or understanding Turkish
- Not having cognitive skills to perform the tests
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
2 Minute Walk Test
Time frame: 3 March 2021
Amputee Mobility Predictor
Time frame: 3 March 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by Hacettepe University.
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 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 19 Feb 2020. 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?
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?
2 Minute Walk Test (time frame: 3 March 2021). The study lists 2 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 19 Feb 2020.