Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05989243

Conditions

Transtibial Amputation

Transfemoral Amputation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Conventional prosthetic socket

Adjustable Quatro socket

Study Details

Brief 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.

Conditions

Transtibial Amputation

Transfemoral Amputation

Study ID

NCT05989243

Start date

Jan 31, 2022

Status verified date

Apr, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Veterans with a transtibial amputation

20 Veterans with a transtibial amputation, 10 females and 10 males

Veterans with a transfemoral amputation

20 Veterans with a transfemoral amputation, 10 females and 10 males

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 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.

Primary outcome measure

  • Biomechanical Asymmetry [ Time Frame: through study completion, an average of 4 years ]
  • Prosthetic Evaluation Questionnaire [ Time Frame: through study completion, an average of 4 years ]

Central Contacts and Locations

Central contacts

Alena Grabowski, PhD BA

(720) 435-4270Alena.Grabowski@va.gov

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Alena Grabowski, PhD BA

720-435-4270Alena.Grabowski@va.gov

Principal Investigator:

Alena Grabowski, PhD BA

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Biomechanics
  • Kinematics
  • Walking
  • Prostheses

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-23.