Clinical trial NCT04038580: A Comparative Assessment of Transfemoral Prosthetic Sockets
Official title: A Comparative Assessment of Conventional and Adjustable Transfemoral Prosthetic Sockets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Amputation; Traumatic, Leg, Lower
Keywords: Socket
Transfemoral
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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?

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

Primary outcomes:
measure: Change in Comfort between laminated and adjustable sockets using the Socket Fit Comfort Score
timeFrame: Baseline and 3 weeks post-intervention
measure: Change in Comfort between laminated and adjustable prosthesis using the Socket Fit Comfort Score
timeFrame: baseline and 3 weeks post-intervention
measure: Change in Satisfaction and Quality of life between laminated and adjustable sockets using the Prosthetic Evaluation Questionnaire (PEQ)
timeFrame: Baseline and 3 weeks post-intervention
measure: Change in Prosthetic Satisfaction between laminated and adjustable sockets using the Prosthetic Socket Preference Questionnaire
timeFrame: Baseline and 3 weeks post-intervention
measure: Change in Confidence in different activities between laminated and adjustable sockets using the Activities Specific Balance Confidence Scale (ABC Scale)
timeFrame: Baseline and 3 weeks post-intervention
measure: Change in mobility as measured by the 10-meter walk test
timeFrame: day 1 and 3 weeks post-intervention
measure: Change in mobility as measured by Timed Up and Go (TUG)
timeFrame: baseline and 3 weeks post-intervention
measure: Change in mobility as measured by Five Times Sit To Stand (FTSTS)
timeFrame: baseline and 3 weeks post-intervention
measure: Change in mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item short form
timeFrame: Baseline and 3 weeks post-intervention
measure: Change in mobility as measured by the L-Test
timeFrame: Baseline and 3 weeks post-intervention
measure: Change in Prosthetic Wear Time between laminated and adjustable sockets
timeFrame: Baseline and 3 weeks post-intervention
measure: Change in physical activity levels at home between laminated and adjustable sockets
timeFrame: Baseline and 3 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rosalind Franklin University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: