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

VA Office of Research and Development40 enrolled

Overview

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.

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

Conditions

Transtibial Amputation Transfemoral Amputation

Interventions

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 socketDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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. The investigators will compare asymmetry between groups and sockets.

Time frame: 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. The investigators will compare overall and domain-specific scores between groups and sockets.

Time frame: through study completion, an average of 4 years

Secondary Outcomes

Socket pistoning

Movement of the residual limb within the socket. The investigators will compared socket pistoning between groups and sockets.

Time frame: through study completion, an average of 4 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts