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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Transtibial Amputation; Transfemoral Amputation
• Intervention / Treatment: Device: Conventional prosthetic socket; Device: Adjustable Quatro socket

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Alena Grabowski, PhD BA; Phone Number: (720) 435-4270; Email: Alena.Grabowski@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Alena Grabowski, PhD BA; Phone Number: (720) 435-4270; Email: Alena.Grabowski@va.gov
      • Contact: Alena Grabowski, PhD BA; Phone Number: 720-435-4270; Email: Alena.Grabowski@va.gov
      • Principal Investigator: Alena Grabowski, PhD BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral transfemoral amputation

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Veterans with a transtibial amputation; 20 Veterans with a transtibial amputation, 10 females and 10 males	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.; Device: 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.
Veterans with a transfemoral amputation; 20 Veterans with a transfemoral amputation, 10 females and 10 males	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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Alena Grabowski, PhD BA, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Biomechanics; Walking; Kinematics; Prostheses
• Other Study ID Numbers: A3643-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No