A Comparative Assessment of Transfemoral Prosthetic Sockets

A Comparative Assessment of Conventional and Adjustable Transfemoral Prosthetic Sockets

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

Study Overview

• Status: Active, not recruiting
• Conditions: Amputation; Amputation; Traumatic, Leg, Lower
• Intervention / Treatment: Device: Laminated Socket; Device: Quatro; Device: Infinite Socket; Device: CJ Socket

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deanna Gates; Phone Number: 734-647-5514; Email: gatesd@umich.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60064
      • Rosalind Franklin University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Prescribed Laminated Socket; In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks.	Device: Laminated Socket; This is the currently prescribed socket the participant normally wears.
Experimental: Adjustable Sockets; 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; The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.; Device: Infinite Socket; 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.; Device: CJ Socket; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?"	Baseline and 3 weeks post-intervention
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?"	baseline and 3 weeks post-intervention
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.	Baseline and 3 weeks post-intervention
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.	Baseline and 3 weeks post-intervention
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.	Baseline and 3 weeks post-intervention
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).	day 1 and 3 weeks post-intervention
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.	baseline and 3 weeks post-intervention
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.	baseline and 3 weeks post-intervention
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.	Baseline and 3 weeks post-intervention
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	Baseline and 3 weeks post-intervention
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.	Baseline and 3 weeks post-intervention
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.	Baseline and 3 weeks post-intervention

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Transfemoral; Socket
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: HUM00140733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will be deidentified for publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes