A Comparative Assessment of Transfemoral Prosthetic Sockets

Not Applicable

Completed

• Conditions: Amputation; Amputation; Traumatic, Leg, Lower

• Registration Number: NCT04038580
• Lead Sponsor: University of Michigan

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?

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-31
• Study Start: 2019-08-15
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Results First Submitted: 2025-07-16
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Results First Posted: 2025-09-29
• Last Update Posted: 2025-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Socket Fit Comfort Score	After at least 3 weeks of prosthetic socket use	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?"
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)	After at least 3 weeks of prosthetic socket use	The PEQ consists of 82 items of which 41 items form nine subscales concerning Prosthesis Utility (UT), Residual Limb Health (RL), Appearance (AP), Sounds (SO), Ambulation (AM), Perceived Response (PR), Frustration (FR), Social Burden (SB), and Well-Being (WB). The remaining 41 items are analyzed as single items. These items are scored on a 100-mm visual analog scale with descriptors at the extremes (e.g. never and all the time). The scales are calculated as averages of the items on a metric from 0 to 100 with higher scores indicating better health.
Activities Specific Balance Confidence Scale	After at least 3 weeks of prosthetic socket use	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.
Mobility as Measured by the 10-meter Walk Test	after at least 4 weeks of prosthetic socket use	The 10-m walk test measures elapsed time over 10 m from a standing start. Participants complete one practice trial and then two test trials. The outcome is the average speed walked during the two trials.
Mobility as Measured by Timed Up and Go (TUG)	after at least 4 weeks of prosthetic socket use	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. The best of three trials was recorded.
Mobility as Measured by Five Times Sit To Stand (FTSTS)	after at least 4 weeks of prosthetic socket use	FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form	After at least 3 weeks of prosthetic socket use	The PLUS-M 12-item short form assess self-reported mobility. The questions are summed and the score is converted to a T-Score (e.g. 50 indicates the population mean with a standard deviation of 10). Values higher than 50 indicate self-reported mobility better than the average person with lower limb amputation, while those less than 50 are below the average.

Secondary Outcome Measures

Name	Time	Method
Prosthetic Wear Time	After at least 3 weeks of prosthetic socket use	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 to Complete the L Test	After 4 weeks of prosthetic socket use	The L test 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. The fastest time out of three trials was recorded.
Steps Per Day Taken at Home	After three weeks of device use	Participants will wear accelerometers to measure their average step count per day over a one week time frame. Data will be collected after at least three weeks of socket use.
Prosthetic Preference	After at least three weeks of prosthetic socket use.	The prosthetic preference questionnaire consisted of a single question which asked which socket the participant preferred on a 100 mm visual analog scale from their prescribed 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 experimental socket.

Trial Locations

Locations (2)

Rosalind Franklin University; 🇺🇸 Chicago, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States