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NCT Number: NCT05989243

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

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.

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Key information

Conditions

Transtibial Amputation Transfemoral Amputation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location status: Recruiting

Location contact

Alena Grabowski, PhD BA

CONTACT

[email protected]

720-435-4270

Alena Grabowski, PhD BA

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Conventional prosthetic socket

Device

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

Device

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.

Primary outcomes

  1. Biomechanical Asymmetry

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

    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.

  2. Prosthetic Evaluation Questionnaire

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

    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.

Secondary outcomes

  1. Socket pistoning

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alena Grabowski, PhD BA

CONTACT

[email protected]

(720) 435-4270

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: SocketFit

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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