AmputationNCT06874582
Evaluation of Individuals with Partial or Finger Amputation After Silicone Prosthesis Use
A study testing silicone hand or finger prosthesis and silicone foot and foot toe prosthesis in people with Amputation and Quality of Life, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aimed to evaluate the psychosocial adaptation, functional capacity, and quality of life of individuals who underwent partial hand or foot amputations after using silicone hand and foot prostheses. Materials and Methods: The study included 32 patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Amputation, Quality of Life, Psychosocial Adaptation
- What is being tested?
- silicone hand or finger prosthesis and silicone foot and foot toe prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 13 May 2022
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hand and foot amputation.
- Aged between 18 and 60 years
- Active employee
- Able to walk, co-operate, move actively with hands
- Who have been using prosthesis for at least 1 year and have good stump-socket compatibility,
- Literate individuals were determined on a voluntary basis.
Who cannot join
- Multiple amputations
- Severe neurological or traumatic findings
- Individuals with severe deformity or posture disorder that may lead to loss of gait, balance or function.
- With limitation of movement in the upper extremities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Istanbul
About this study
Official title: EVALUATION of QUALITY of LIFE, PSYCHOSOCIAL ADAPTATION, and FUNCTIONALITY in SILICONE PROSTHESIS USERS
Objective: This study aimed to evaluate the psychosocial adaptation, functional capacity, and quality of life of individuals who underwent partial hand or foot amputations after using silicone hand and foot prostheses.
Materials and Methods: The study included 32 patients. Demographic and clinical characteristics of the participants were recorded. Participants were divided into two groups as silicone hand or foot prosthesis users. The Visual Analog Scale (VAS) was used to assess pain levels before and after prosthesis use, the Trinity Amputation and Prosthesis Experience Scales (TAPES) were applied to evaluate functional capacity, and the Nottingham Health Profile (NHP) was used to assess quality of life.
- Being tested
- silicone hand or finger prosthesis, silicone foot and foot toe prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone hand or finger prosthesisDevice
To the best of the author's knowledge, no previous studies have evaluated and compared customised finger and partial silicone prostheses in both extremities. This feature distinguishes the present study from other studies.
silicone foot and foot toe prosthesisDevice
To the best of the author's knowledge, no previous studies have evaluated and compared customised finger and partial silicone prostheses in both extremities. This feature distinguishes the present study from other studies.
| Study group | Role | What they receive |
|---|---|---|
| silicone hand or finger prosthesis users | Active comparator | The first arm of our study consisted of participants with partial or finger amputation and silicone hand-finger prosthesis. Receives: Device: silicone hand or finger prosthesis |
| silicone foot or toe prostheses users | Active comparator | The second arm of our study consisted of participants with partial or finger amputation and silicone foot-foot toe prosthesis. Receives: Device: silicone foot and foot toe prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nottingham Health Profile (NHP)
The NHP questionnaire consists of two sections with "Yes-No" responses. The first section includes dimensions such as energy levels, pain, emotional reactions, sleep, social isolation, and physical abilities, while the second section addresses the impact of poor health on daily life, covering areas such as employment, household activities, social life, relationships, sexual life, hobbies, and vacations. The first section's total score ranges from 0-600, with higher scores indicating lower activity. The second section ranges from 0-7, with higher scores indicating lower activity.
Measured: through study completion, an average of 1 year
Trinity Amputation and Prosthesis Experience Scales (TAPES)
The TAPES questionnaire evaluates psychosocial adaptation, functionality, and prosthesis satisfaction. It comprises two main sections with nine subscales. The psychosocial subscales include general adaptation, social adaptation, and restriction adaptation, with each rated on a five-point scale (1: Strongly Disagree to 5: Strongly Agree). Scores range from 5 to 25, with higher scores indicating better adaptation.
Measured: through study completion, an average of 1 year
Visual Analog Scale(VAS)
The VAS was used to measure pain in the stump before and after silicone prosthesis use. They were asked to draw their pain level on a 10 cm scale between 0-10 points as 0=no pain, 10 unbearable pain
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start15 Oct 2021
- Primary completion12 Apr 2022
- Study completion13 May 2022
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA ATILGAN, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874582
- Sponsor's protocol ID
- E-10840098-772.02-5247
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION of QUALITY of LIFE, PSYCHOSOCIAL ADAPTATION, and FUNCTIONALITY in SILICONE PROSTHESIS USERS
- ClinicalTrials.gov ID
- NCT06874582
- Acronym / sponsor ID
- E-10840098-772.02-5247
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 13 Mar 2025 (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.
Objective: This study aimed to evaluate the psychosocial adaptation, functional capacity, and quality of life of individuals who underwent partial hand or foot amputations after using silicone hand and foot prostheses.
Materials and Methods: The study included 32 patients. Demographic and clinical characteristics of the participants were recorded. Participants were divided into two groups as silicone hand or foot prosthesis users. The Visual Analog Scale (VAS) was used to assess pain levels before and after prosthesis use, the Trinity Amputation and Prosthesis Experience Scales (TAPES) were applied to evaluate functional capacity, and the Nottingham Health Profile (NHP) was used to assess quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silicone hand or finger prosthesis users | Active comparator | Device: silicone hand or finger prosthesisThe first arm of our study consisted of participants with partial or finger amputation and silicone hand-finger prosthesis. |
| silicone foot or toe prostheses users | Active comparator | Device: silicone foot and foot toe prosthesisThe second arm of our study consisted of participants with partial or finger amputation and silicone foot-foot toe prosthesis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Hand and foot amputation.
- Aged between 18 and 60 years
- Active employee
- Able to walk, co-operate, move actively with hands
- Who have been using prosthesis for at least 1 year and have good stump-socket compatibility,
Key exclusion criteria (4 listed)
- Multiple amputations
- Severe neurological or traumatic findings
- Individuals with severe deformity or posture disorder that may lead to loss of gait, balance or function.
- With limitation of movement in the upper extremities
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 |
|---|---|---|
| silicone hand or finger prosthesisTo the best of the author's knowledge, no previous studies have evaluated and compared customised finger and partial silicone prostheses in both extremities. This feature distinguishes the present study from other studies. | Device | silicone hand or finger prosthesis users |
| silicone foot and foot toe prosthesisTo the best of the author's knowledge, no previous studies have evaluated and compared customised finger and partial silicone prostheses in both extremities. This feature distinguishes the present study from other studies. | Device | silicone foot or toe prostheses users |
Primary outcome
Nottingham Health Profile (NHP)
Time frame: through study completion, an average of 1 year
The NHP questionnaire consists of two sections with "Yes-No" responses. The first section includes dimensions such as energy levels, pain, emotional reactions, sleep, social isolation, and physical abilities, while the second section addresses the impact of poor health on daily life, covering areas such as employment, household activities, social life, relationships, sexual life, hobbies, and vacations. The first section's total score ranges from 0-600, with higher scores indicating lower activity. The second section ranges from 0-7, with higher scores indicating lower activity.
Trinity Amputation and Prosthesis Experience Scales (TAPES)
Time frame: through study completion, an average of 1 year
The TAPES questionnaire evaluates psychosocial adaptation, functionality, and prosthesis satisfaction. It comprises two main sections with nine subscales. The psychosocial subscales include general adaptation, social adaptation, and restriction adaptation, with each rated on a five-point scale (1: Strongly Disagree to 5: Strongly Agree). Scores range from 5 to 25, with higher scores indicating better adaptation.
Visual Analog Scale(VAS)
Time frame: through study completion, an average of 1 year
The VAS was used to measure pain in the stump before and after silicone prosthesis use. They were asked to draw their pain level on a 10 cm scale between 0-10 points as 0=no pain, 10 unbearable pain
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 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing silicone hand or finger prosthesis and silicone foot and foot toe prosthesis in people with Amputation and Quality of Life, 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 6 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: finished, as of the sponsor's last update on 13 Mar 2025. 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?
Nottingham Health Profile (NHP) (time frame: through study completion, an average of 1 year). The study lists 3 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 13 Mar 2025.