Back to resultsA Comparative Assessment of Transfemoral Prosthetic Sockets
Primary Purpose
Amputation, Amputation; Traumatic, Leg, Lower
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laminated Socket
Quatro
Infinite Socket
CJ Socket
Sponsored by
About this trial
This is an interventional basic science trial for Amputation focused on measuring Socket, Transfemoral
Eligibility Criteria
Inclusion Criteria:
- Unilateral lower-limb amputation
- Six months of independent ambulation
- Own and regularly wear a prosthesis with socket
- Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"
Exclusion Criteria:
- Pathology or injury of the intact limb
- Medication that affects their ability to walk
- Neurologic or cardiovascular disease
- Significant vision problems
- Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication
Sites / Locations
- Rosalind Franklin University
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Prescribed Laminated Socket
Adjustable Sockets
Arm Description
In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks.
In this condition, participants will be fitted with 3 different adjustable transfemoral sockets by a certified prosthetist. The order in which the sockets are fitted are randomized and the participant will spend approximately 4 weeks in each socket.
Outcomes
Primary Outcome Measures
Change in Comfort between laminated and adjustable sockets using the Socket Fit Comfort Score
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Change in Comfort between laminated and adjustable prosthesis using the Socket Fit Comfort Score
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Change in Satisfaction and Quality of life between laminated and adjustable sockets using the Prosthetic Evaluation Questionnaire (PEQ)
The PEQ consists of 82 questions that describe the function of a lower-limb prosthesis and assess prosthesis-related quality of life. The questionnaire is divided into ten functional scales, addressing four major domains: prosthetic function, mobility, psychosocial experience, and well-being.
Change in Prosthetic Satisfaction between laminated and adjustable sockets using the Prosthetic Socket Preference Questionnaire
This asks which device they prefer on a 100 mm visual analog scale from their prescribed laminated socket to the test socket. A score of 0 would be 100% preference for their prescribed socket while 100 mm represents 100% preference for the socket tested in that condition.
Change in Confidence in different activities between laminated and adjustable sockets using the Activities Specific Balance Confidence Scale (ABC Scale)
The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation.
Change in mobility as measured by the 10-meter walk test
The 10-m walk test measures elapsed time over 10 m from a standing start (Datta et al. 1996). This measure uses customary walking speed as a measure of walking ability/capacity and has shown content and metric reliability and validity (Deathe et al. 2009).
Change in mobility as measured by Timed Up and Go (TUG)
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down.
Change in mobility as measured by Five Times Sit To Stand (FTSTS)
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Change in mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item short form
The full PLUS-M survey has 44 items and there are two short-forms (12 and 7 items each). Here we will use the 12-item short form as it has shown excellent agreement with the 44-item score and good construct validity (Hafner et al. 2017). Additionally, normative data for 1019 people with lower limb amputation is available at (http://www.plus-m.org) to aid in interpretation of the findings.
Change in mobility as measured by the L-Test
The L-test (Deathe and Miller 2005) is a modified version of the TUG which incorporates two transfers and four turns of which at least one would be to the opposite side (Fig 6). We will complete both tasks as the TUG has ceiling effects in fit individuals and the L-Test can be too difficult for some amputees
Change in Prosthetic Wear Time between laminated and adjustable sockets
Participants will be given sensors to monitor how many times participants don and doff the prosthesis during the day. This sensor will be attached to each socket after the 3rd week of accommodation. This sensor will be worn for 1 week.
Change in physical activity levels at home between laminated and adjustable sockets
Participants will wear accelerometers to measure physical activity and step count. Participants will wear these monitors for 1 week.
Secondary Outcome Measures
Full Information
NCT ID
NCT04038580
First Posted
July 23, 2019
Last Updated
September 12, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04038580
Brief Title
A Comparative Assessment of Transfemoral Prosthetic Sockets
Official Title
A Comparative Assessment of Conventional and Adjustable Transfemoral Prosthetic Sockets
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
Detailed Description
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. The investigators will explore a range of outcomes that have been found to be important for prostheses users and specifically assess the claims made by device manufacturers. Thirty adults with a transfemoral amputation will participate in four test sessions; one with their clinically prescribed, laminated socket, and three with different adjustable sockets. This data will be used to test the following aims: 1) does socket design impact socket comfort and prosthetic satisfaction? 2) does socket design impact of prosthetic socket on patient mobility and confidence, 3) how does prosthetic socket design influences prosthetic use in the home?, and 4) Are individual characteristics associated with benefits of specific socket designs?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Amputation; Traumatic, Leg, Lower
Keywords
Socket, Transfemoral
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prescribed Laminated Socket
Arm Type
Sham Comparator
Arm Description
In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks.
Arm Title
Adjustable Sockets
Arm Type
Experimental
Arm Description
In this condition, participants will be fitted with 3 different adjustable transfemoral sockets by a certified prosthetist. The order in which the sockets are fitted are randomized and the participant will spend approximately 4 weeks in each socket.
Intervention Type
Device
Intervention Name(s)
Laminated Socket
Intervention Description
This is the currently prescribed socket the participant normally wears.
Intervention Type
Device
Intervention Name(s)
Quatro
Intervention Description
The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
Intervention Type
Device
Intervention Name(s)
Infinite Socket
Intervention Description
The Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
Intervention Type
Device
Intervention Name(s)
CJ Socket
Intervention Description
The CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
Primary Outcome Measure Information:
Title
Change in Comfort between laminated and adjustable sockets using the Socket Fit Comfort Score
Description
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Time Frame
Baseline and 3 weeks post-intervention
Title
Change in Comfort between laminated and adjustable prosthesis using the Socket Fit Comfort Score
Description
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Time Frame
baseline and 3 weeks post-intervention
Title
Change in Satisfaction and Quality of life between laminated and adjustable sockets using the Prosthetic Evaluation Questionnaire (PEQ)
Description
The PEQ consists of 82 questions that describe the function of a lower-limb prosthesis and assess prosthesis-related quality of life. The questionnaire is divided into ten functional scales, addressing four major domains: prosthetic function, mobility, psychosocial experience, and well-being.
Time Frame
Baseline and 3 weeks post-intervention
Title
Change in Prosthetic Satisfaction between laminated and adjustable sockets using the Prosthetic Socket Preference Questionnaire
Description
This asks which device they prefer on a 100 mm visual analog scale from their prescribed laminated socket to the test socket. A score of 0 would be 100% preference for their prescribed socket while 100 mm represents 100% preference for the socket tested in that condition.
Time Frame
Baseline and 3 weeks post-intervention
Title
Change in Confidence in different activities between laminated and adjustable sockets using the Activities Specific Balance Confidence Scale (ABC Scale)
Description
The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation.
Time Frame
Baseline and 3 weeks post-intervention
Title
Change in mobility as measured by the 10-meter walk test
Description
The 10-m walk test measures elapsed time over 10 m from a standing start (Datta et al. 1996). This measure uses customary walking speed as a measure of walking ability/capacity and has shown content and metric reliability and validity (Deathe et al. 2009).
Time Frame
day 1 and 3 weeks post-intervention
Title
Change in mobility as measured by Timed Up and Go (TUG)
Description
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down.
Time Frame
baseline and 3 weeks post-intervention
Title
Change in mobility as measured by Five Times Sit To Stand (FTSTS)
Description
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Time Frame
baseline and 3 weeks post-intervention
Title
Change in mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item short form
Description
The full PLUS-M survey has 44 items and there are two short-forms (12 and 7 items each). Here we will use the 12-item short form as it has shown excellent agreement with the 44-item score and good construct validity (Hafner et al. 2017). Additionally, normative data for 1019 people with lower limb amputation is available at (http://www.plus-m.org) to aid in interpretation of the findings.
Time Frame
Baseline and 3 weeks post-intervention
Title
Change in mobility as measured by the L-Test
Description
The L-test (Deathe and Miller 2005) is a modified version of the TUG which incorporates two transfers and four turns of which at least one would be to the opposite side (Fig 6). We will complete both tasks as the TUG has ceiling effects in fit individuals and the L-Test can be too difficult for some amputees
Time Frame
Baseline and 3 weeks post-intervention
Title
Change in Prosthetic Wear Time between laminated and adjustable sockets
Description
Participants will be given sensors to monitor how many times participants don and doff the prosthesis during the day. This sensor will be attached to each socket after the 3rd week of accommodation. This sensor will be worn for 1 week.
Time Frame
Baseline and 3 weeks post-intervention
Title
Change in physical activity levels at home between laminated and adjustable sockets
Description
Participants will wear accelerometers to measure physical activity and step count. Participants will wear these monitors for 1 week.
Time Frame
Baseline and 3 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral lower-limb amputation
Six months of independent ambulation
Own and regularly wear a prosthesis with socket
Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"
Exclusion Criteria:
Pathology or injury of the intact limb
Medication that affects their ability to walk
Neurologic or cardiovascular disease
Significant vision problems
Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication
Facility Information:
Facility Name
Rosalind Franklin University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be deidentified for publication.
Learn more about this trial
A Comparative Assessment of Transfemoral Prosthetic Sockets
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