Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

Transfemoral Amputation Clinical Trial

— SocketFit  

Official title:

Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989243
• Other study ID #: A3643-R
• Status: Recruiting
• Start date: January 31, 2022
• Est. completion date: January 30, 2026

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Alena Grabowski, PhD BA
• Phone: (720) 435-4270
• Email: Alena.Grabowski[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

Description:

The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The investigators will enroll up to 40 Veterans
• 20 with unilateral transtibial amputation
• 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old
• All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
• Participants will be at or above a K2 MFCL, defined as a person who has 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:

• Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)

Related Conditions & MeSH terms

• Transfemoral Amputation
• Transtibial Amputation

Intervention

Device:
• Conventional prosthetic socket
Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
• Adjustable Quatro socket
Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomechanical Asymmetry	The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. We will compare asymmetry between groups and sockets.	through study completion, an average of 4 years
Primary	Prosthetic Evaluation Questionnaire	The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. We will compare overall and domain-specific scores between groups and sockets.	through study completion, an average of 4 years
Secondary	Socket pistoning	Movement of the residual limb within the socket. We will compared socket pistoning between groups and sockets.	through study completion, an average of 4 years