A Comparative Assessment of Transfemoral Prosthetic Sockets

NCT04038580 | Completed Results FDA Device

• 1 other identifier: HUM00140733
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

Conditions

Amputation; Amputation; Traumatic, Leg, Lower

Keywords

Socket; Transfemoral

Outcome Measures

Primary Outcomes (7)

• 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?"

  After at least 3 weeks of prosthetic socket use

• Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)

  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.

  After at least 3 weeks of prosthetic socket use

• Activities Specific Balance Confidence 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.

  After at least 3 weeks of prosthetic socket use

• Mobility as Measured by the 10-meter Walk Test

  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.

  after at least 4 weeks of prosthetic socket use

• 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. The best of three trials was recorded.

  after at least 4 weeks of prosthetic socket use

• Mobility as Measured by Five Times Sit To Stand (FTSTS)

  FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.

  after at least 4 weeks of prosthetic socket use

• Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form

  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.

  After at least 3 weeks of prosthetic socket use

Secondary Outcomes (4)

• Prosthetic Wear Time

  After at least 3 weeks of prosthetic socket use

• Time to Complete the L Test

  After 4 weeks of prosthetic socket use

• Steps Per Day Taken at Home

  After three weeks of device use

• Prosthetic Preference

  After at least three weeks of prosthetic socket use.

Study Arms (2)

Prescribed Laminated Socket

SHAM COMPARATOR

In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks.

Device: Laminated Socket

Adjustable Sockets

EXPERIMENTAL

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.

Device: Quatro; Device: Infinite Socket; Device: CJ Socket

Interventions

Laminated Socket DEVICE

This is the currently prescribed socket the participant normally wears.

Prescribed Laminated Socket

Quatro DEVICE

The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Adjustable Sockets

Infinite Socket DEVICE

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.

Adjustable Sockets

CJ Socket DEVICE

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.

Adjustable Sockets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

Rosalind Franklin University

Chicago, Illinois, 60064, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Dr. Deanna Gates
• Organization: University of Michigan

gatesd@umich.edu

7346472698

Study Officials

• Deanna H Gates, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 31, 2019
• Study Start: August 15, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)