E-Socket, Diagnostic Monitoring

Not Applicable

Not yet recruiting

• Conditions: Trans-Tibial Amputation
• Interventions: Other: E-Socket Monitoring

• Registration Number: NCT06432335
• Lead Sponsor: University of Washington

Brief Summary

The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).

Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.

Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-29
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Study Start: 2025-07-01
• Primary Completion: 2029-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Prosthesis Users:

Aims 1 and 2

• Over 18 years of age
• Unilateral or bilateral trans-tibial amputation at least 12 months prior
• Have a limb of length 9 cm or greater
• Are capable of at least 5 minutes of continuous walking
• Regularly use a definitive prosthesis
• Do not regularly use assistive devices (e.g., cane, walker) for ambulation
• Do not have open wounds on their residual limb at the time of enrollment

Aim 2

-Regularly visit their prosthetist at least twice a year,

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Exclusion Criteria

Prosthesis Users:

Aims 1 and 2

• Reduced skin sensation
• Presence of skin breakdown
• Regular use of an assistive device
• Persons with trans-femoral amputation

Aim 1 Only

-Vacuum suspension users

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E-Socket Monitoring	E-Socket Monitoring	-

Primary Outcome Measures

Name	Time	Method
Anterior-Distal Limb Motion	12 months	Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.