Transtibial Amputation - UnilateralNCT06599060
Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
An observational study of Transtibial Amputation - Unilateral, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transtibial Amputation - Unilateral
- What is being tested?
- Trinity Amputation and Prosthesis Experience Scale
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2020to 15 May 2021
- How long will I take part?
- 1 Year
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Information on patients who had undergone unilateral transtibial prosthesis placement in previous years was obtained from the patient records of the Nesa Prosthetics Orthotics Production and Application Center.
Who may be able to join
- between 18-75
- unilateral below knee amputation
- volunteer to participate
- have been using a transtibial prosthesis for at least one year
- can read and understand Turkish.
Who cannot join
- muscle strength and sensory loss in the intact extremity that may affect ambulation
- upper limb amputees
- congenital amputees
- bilateral amputees
- mentally disabled
- with neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years. The Prosthesis Satisfaction Questionnaire (PSQ) and Trinity Amputation and Prosthesis Experience Scale (TAPES) were used to measure prosthesis satisfaction. Data analyses were performed using SPSS for Windows version 24.0 program. No significant data were found when the SATPRO scale scores were compared with general information. The TAPES activity restriction scale scores were lower in women than in men (p\<0.05). When the causes of amputation were compared, the mean scores of the TAPES activity restriction, TAPES athletic restriction, and TAPES social restriction subscales were higher in amputees with vascular causes than in those with traumatic and other causes (p\<0.05). Satisfaction with TAPES prosthesis weight was lower in vascular amputees than in traumatic and other amputees (P \<0.05). The TAPES restriction compliance score was higher in the vascular amputee group than in the traumatic and other cause groups (p\<0.05). There was no difference in the TAPES and SATPRO scores according to the different types of prostheses used by the amputees (p\>0.05). Researchers believe that the cause of amputation and cosmetic limitations affect prosthesis satisfaction and are also important for prosthesis adaptation and socialization for users.
- Conditions
- Transtibial Amputation - Unilateral
- Being tested
- Trinity Amputation and Prosthesis Experience Scale
- Keywords
- transtibial amputees, prosthesis satisfaction, prosthesis experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trinity Amputation and Prosthesis Experience ScaleOther
Also called Satisfaction with Prosthesis Questionnaire
Participants were administered a questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Trinity Amputation and Prosthetic Experience Scales (TAPES)
It will be used to evaluate the prosthetic experience.
Measured: 0-1 years
Secondary outcomes (1)
Satisfaction with the Prosthesis (SATPRO) Questionnaire
It will be used to assess denture satisfaction.
Measured: 0-1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Dec 2020
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial Amputation - UnilateralStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Cohort
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande YAZICI, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599060
- Sponsor's protocol ID
- YaziciH
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
- ClinicalTrials.gov ID
- NCT06599060
- Acronym / sponsor ID
- YaziciH
- Conditions
- Transtibial Amputation - Unilateral
- Keywords
- transtibial amputees, prosthesis satisfaction, prosthesis experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 19 Sep 2024 (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.
This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years. The Prosthesis Satisfaction Questionnaire (PSQ) and Trinity Amputation and Prosthesis Experience Scale (TAPES) were used to measure prosthesis satisfaction. Data analyses were performed using SPSS for Windows version 24.0 program. No significant data were found when the SATPRO scale scores were compared with general information. The TAPES activity restriction scale scores were lower in women than in men (p\<0.05). When the causes of amputation were compared, the mean scores of the TAPES activity restriction, TAPES athletic restriction, and TAPES social restriction subscales were higher in amputees with vascular causes than in those with traumatic and other causes (p\<0.05). Satisfaction with TAPES prosthesis weight was lower in vascular amputees than in traumatic and other amputees (P \<0.05). The TAPES restriction compliance score was higher in the vascular amputee group than in the traumatic and other cause groups (p\<0.05). There was no difference in the TAPES and SATPRO scores according to the different types of prostheses used by the amputees (p\>0.05). Researchers believe that the cause of amputation and cosmetic limitations affect prosthesis satisfaction and are also important for prosthesis adaptation and socialization for users.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Information on patients who had undergone unilateral transtibial prosthesis placement in previous years was obtained from the patient records of the Nesa Prosthetics Orthotics Production and Application Center.
Key inclusion criteria (5 listed)
- between 18-75
- unilateral below knee amputation
- volunteer to participate
- have been using a transtibial prosthesis for at least one year
- can read and understand Turkish.
Key exclusion criteria (6 listed)
- muscle strength and sensory loss in the intact extremity that may affect ambulation
- upper limb amputees
- congenital amputees
- bilateral amputees
- mentally disabled
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 |
|---|---|---|
| Trinity Amputation and Prosthesis Experience ScaleAlso: Satisfaction with Prosthesis QuestionnaireParticipants were administered a questionnaire. | Other | – |
Primary outcome
Trinity Amputation and Prosthetic Experience Scales (TAPES)
Time frame: 0-1 years
It will be used to evaluate the prosthetic experience.
1 secondary outcome
Satisfaction with the Prosthesis (SATPRO) Questionnaire
Time frame: 0-1 years
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 19 Sep 2024.
- Related InfoLink provided by the sponsor.
- 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.
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 Transtibial Amputation - Unilateral, run by Medipol 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 5 inclusion and 6 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 19 Sep 2024. 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?
Trinity Amputation and Prosthetic Experience Scales (TAPES) (time frame: 0-1 years). 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 Sep 2024.