NCT05989243

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2022Mar 2027

Study Start

First participant enrolled

January 31, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

5.2 years

First QC Date

August 2, 2023

Last Update Submit

April 20, 2026

Conditions

Transtibial AmputationTransfemoral Amputation

Keywords

BiomechanicsKinematicsWalkingProstheses

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    through study completion, an average of 4 years

Secondary Outcomes (1)

  • Socket pistoning

    through study completion, an average of 4 years

Study Arms (2)

Veterans with a transtibial amputation

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

Device: Conventional prosthetic socketDevice: Adjustable Quatro socket

Veterans with a transfemoral amputation

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

Device: Conventional prosthetic socketDevice: Adjustable Quatro socket

Interventions

Conventional prosthetic socketDEVICE

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.

Veterans with a transfemoral amputationVeterans with a transtibial amputation
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.

Veterans with a transfemoral amputationVeterans with a transtibial amputation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • The investigators will enroll up to 40 Veterans
  • with unilateral transtibial amputation
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

Study Officials

  • Alena Grabowski, PhD BA

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alena Grabowski, PhD BA

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

January 31, 2022

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)