AmputeesNCT04155762
Effects of Pin and Vacuum Assisted Suspension Systems
A study testing Pin Suspension System (a prosthetic suspension system) and Vacuum-Assisted Suspension System (a prosthetic suspension system) in people with Amputees and Prosthesis User, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study was performed to determine the presence of any difference between Pin Suspension (PS) and Active Vacuum Suspension (AVS) on walking capacity, functional mobility, weight bearing in the prosthetic side, prosthetic satisfaction and body image were evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputees, Prosthesis User, Artificial Limbs
- What is being tested?
- Pin Suspension System (a prosthetic suspension system) and Vacuum-Assisted Suspension System (a prosthetic suspension system)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2015to 1 Feb 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being able to walk without the use of any assistive device,
- Having normal range of motion in the hip and knee at the amputated side.
Who cannot join
- Having any disadvantage about prosthetic device usage in terms of stump length, shape and edema,
- Having movement limitation,
- Having any discomfort or health problem (cardiopulmonary, neurological or orthopedic problems) that may affect gait other than amputation,
- Having multiple extremity loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effects of Pin and Vacuum Assisted Suspension Systems in Transtibial Amputees
This study was performed to determine the presence of any difference between Pin Suspension (PS) and Active Vacuum Suspension (AVS) on walking capacity, functional mobility, weight bearing in the prosthetic side, prosthetic satisfaction and body image were evaluated. Nine patients who don't have an obstacle to both socket applications in terms of stump height, type and edema were evaluated in this study. Both suspension systems were administered to the patients included in the study. First, amputees have used PS for 3 months following alignment of the prosthesis and training period. Then again they used AVS for 3 months following alignment of the prosthesis and training period. For each system, after adapting prosthesis 'LASAR posture' was used to evaluate weight bearing on the prosthetic side, '6 Minute Walk Test' for walking capacity, 'Time Up and Go' test for functional mobility, 'Prosthetic Satisfaction Index' for prosthetic satisfaction and 'Amputee Body Image Scale' for body. There were statistically significant difference between PS and AVS in terms of prosthetic side weight bearing percentage, walking capacity, functional mobility and prosthetic satisfaction (p<0.05), in favor of AVS. There were not statistically significant difference between the body image scores (p>0.05). From the view of function and prosthetic satisfaction, AVS was found to be more effective in transtibial amputees. It is believed that our study will be a guide to the future studies including higher number of amputees, different amputation levels and different suspension systems.
- Conditions
- Amputees, Prosthesis User, Artificial Limbs
- Being tested
- Pin Suspension System (a prosthetic suspension system), Vacuum-Assisted Suspension System (a prosthetic suspension system)
- Keywords
- Amputees, Artificial Limbs, Prosthetic designs, Rehabilitation of prostheses users, Prosthetic suspension systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pin Suspension System (a prosthetic suspension system)Other
Participants used the PSS for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period.
Vacuum-Assisted Suspension System (a prosthetic suspension system)Other
After PSS, participants employed the VASS for three months after a similar training period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Both suspension systems were applied consecutively to the participants. Initially, participants used the Pin Suspension System (PSS) for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period. They then employed the Vacuum-Assisted Suspension System (VASS) for three months after a similar training period. Receives: Other: Pin Suspension System (a prosthetic suspension system); Other: Vacuum-Assisted Suspension System (a prosthetic suspension system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-bearing on the prosthetic side
The percentage of total body weight borne on the amputated limb will be recorded.
Measured: 3 minutes
Walking capacity
"Six Minutes Walk Test" will be used to assess walking capacity. Participants will walk for 6 minutes between two points which are 24 meters apart. The total meters walked during those 6 minutes will be recorded.
Measured: 6 minutes
Functional mobility
"The Timed Up and Go Test" will be used to assess functional mobility. The test starts from the seated position on the chair. With the onset of time, the participant leaves the chair, walks for 3 meters, turns 180 degrees, returns to the starting point, and sits in the chair back. The test is finished when the participant is returned to the initial position and the total time is recorded in seconds.
Measured: 1 minute
Prosthetic satisfaction
"Satisfaction with Prosthesis Questionnaire" (SAT-PRO) is a self-administered questionnaire for determining the participants' satisfaction with the use of the prosthesis. It consists of 15 items. For each item, participants mark the number that best describes their satisfaction with current prosthesis (3: totally agree, 2: rather agree, 1: rather disagree, 0: totally disagree). The items 6, 12 and 14 are scored in reverse. In total, lower scores indicate higher satisfaction; the maximum score that can be taken in the questionnaire is 45 points which means 100% satisfaction and 0 points means 0% satisfaction.
The Turkish version of the SAT-PRO is a valid and reliable test that can be used to evaluate the prosthetic satisfaction of people with lower extremity amputation.
Measured: 5 minutes
Body image perception
"The Amputee Body Image Scale" (ABIS) is a self-administered questionnaire for determining how an amputee perceives and feels about his/her body experience. It consists of 20 items. The items 3, 12 and 16 are scored in reverse. The total score varies from 20 to 100; lower scores indicate better body image.
The Turkish version of the ABIS was found to be valid and reliable.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Feb 2015
- Primary completion1 Feb 2017
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Senay Cerezci Duygu, Baskent University
- Investigators
- Fatih Erbahceci, Prof, Study chair, Hacettepe UniversityBahar Kulunkoglu, Assoc Prof, Principal investigator, Ankara Yildirim Beyazıt UniversitySenay Cerezci Duygu, MsC, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155762
- Sponsor's protocol ID
- GO 15/123
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Pin and Vacuum Assisted Suspension Systems in Transtibial Amputees
- ClinicalTrials.gov ID
- NCT04155762
- Acronym / sponsor ID
- GO 15/123
- Conditions
- Amputees, Prosthesis User, Artificial Limbs
- Keywords
- Amputees, Artificial Limbs, Prosthetic designs, Rehabilitation of prostheses users, Prosthetic suspension systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 7 Nov 2019 (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 was performed to determine the presence of any difference between Pin Suspension (PS) and Active Vacuum Suspension (AVS) on walking capacity, functional mobility, weight bearing in the prosthetic side, prosthetic satisfaction and body image were evaluated. Nine patients who don't have an obstacle to both socket applications in terms of stump height, type and edema were evaluated in this study. Both suspension systems were administered to the patients included in the study. First, amputees have used PS for 3 months following alignment of the prosthesis and training period. Then again they used AVS for 3 months following alignment of the prosthesis and training period. For each system, after adapting prosthesis 'LASAR posture' was used to evaluate weight bearing on the prosthetic side, '6 Minute Walk Test' for walking capacity, 'Time Up and Go' test for functional mobility, 'Prosthetic Satisfaction Index' for prosthetic satisfaction and 'Amputee Body Image Scale' for body. There were statistically significant difference between PS and AVS in terms of prosthetic side weight bearing percentage, walking capacity, functional mobility and prosthetic satisfaction (p<0.05), in favor of AVS. There were not statistically significant difference between the body image scores (p>0.05). From the view of function and prosthetic satisfaction, AVS was found to be more effective in transtibial amputees. It is believed that our study will be a guide to the future studies including higher number of amputees, different amputation levels and different suspension systems.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Pin Suspension System (a prosthetic suspension system), Other: Vacuum-Assisted Suspension System (a prosthetic suspension system)Both suspension systems were applied consecutively to the participants. Initially, participants used the Pin Suspension System (PSS) for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period. They then employed the Vacuum-Assisted Suspension System (VASS) for three months after a similar training period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being able to walk without the use of any assistive device,
- Having normal range of motion in the hip and knee at the amputated side.
Key exclusion criteria (4 listed)
- Having any disadvantage about prosthetic device usage in terms of stump length, shape and edema,
- Having movement limitation,
- Having any discomfort or health problem (cardiopulmonary, neurological or orthopedic problems) that may affect gait other than amputation,
- Having multiple extremity loss.
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 |
|---|---|---|
| Pin Suspension System (a prosthetic suspension system)Participants used the PSS for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period. | Other | Intervention |
| Vacuum-Assisted Suspension System (a prosthetic suspension system)After PSS, participants employed the VASS for three months after a similar training period. | Other | Intervention |
Primary outcome
Weight-bearing on the prosthetic side
Time frame: 3 minutes
The percentage of total body weight borne on the amputated limb will be recorded.
Walking capacity
Time frame: 6 minutes
"Six Minutes Walk Test" will be used to assess walking capacity. Participants will walk for 6 minutes between two points which are 24 meters apart. The total meters walked during those 6 minutes will be recorded.
Functional mobility
Time frame: 1 minute
"The Timed Up and Go Test" will be used to assess functional mobility. The test starts from the seated position on the chair. With the onset of time, the participant leaves the chair, walks for 3 meters, turns 180 degrees, returns to the starting point, and sits in the chair back. The test is finished when the participant is returned to the initial position and the total time is recorded in seconds.
Prosthetic satisfaction
Time frame: 5 minutes
"Satisfaction with Prosthesis Questionnaire" (SAT-PRO) is a self-administered questionnaire for determining the participants' satisfaction with the use of the prosthesis. It consists of 15 items. For each item, participants mark the number that best describes their satisfaction with current prosthesis (3: totally agree, 2: rather agree, 1: rather disagree, 0: totally disagree). The items 6, 12 and 14 are scored in reverse. In total, lower scores indicate higher satisfaction; the maximum score that can be taken in the questionnaire is 45 points which means 100% satisfaction and 0 points means 0% satisfaction. The Turkish version of the SAT-PRO is a valid and reliable test that can be used to evaluate the prosthetic satisfaction of people with lower extremity amputation.
Body image perception
Time frame: 5 minutes
"The Amputee Body Image Scale" (ABIS) is a self-administered questionnaire for determining how an amputee perceives and feels about his/her body experience. It consists of 20 items. The items 3, 12 and 16 are scored in reverse. The total score varies from 20 to 100; lower scores indicate better body image. The Turkish version of the ABIS was found to be valid and reliable.
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 Nov 2019.
- 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.
Fatih Erbahceci, Prof study chair
Hacettepe University
Bahar Kulunkoglu, Assoc Prof principal investigator
Ankara Yildirim Beyazıt University
Senay Cerezci Duygu, MsC study director
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pin Suspension System (a prosthetic suspension system) and Vacuum-Assisted Suspension System (a prosthetic suspension system) in people with Amputees and Prosthesis User, run by Baskent 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 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 12 Nov 2019. 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?
Weight-bearing on the prosthetic side (time frame: 3 minutes). The study lists 5 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 12 Nov 2019.