- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155762
Effects of Pin and Vacuum Assisted Suspension Systems
A Comparison of the Effects of Pin and Vacuum Assisted Suspension Systems in Transtibial Amputees
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06790
- Başkent University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
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Participants used the PSS for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period.
After PSS, participants employed the VASS for three months after a similar training period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight-bearing on the prosthetic side
Time Frame: 3 minutes
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The percentage of total body weight borne on the amputated limb will be recorded.
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3 minutes
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Walking capacity
Time Frame: 6 minutes
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"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.
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6 minutes
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Functional mobility
Time Frame: 1 minute
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"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.
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1 minute
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Prosthetic satisfaction
Time Frame: 5 minutes
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"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. |
5 minutes
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Body image perception
Time Frame: 5 minutes
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"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. |
5 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bahar Kulunkoglu, Assoc Prof, Yildirim Beyazit University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GO 15/123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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