Recruiting

Prosthetic Smart Socket

Sponsor:

University of South Florida

Code:

NCT03199222

Conditions

Complications of the Amputated Limb

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Prosthetic smart socket technology with patient prompting

Study Details

Brief summary:

A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces

Conditions

Complications of the Amputated Limb

Study ID

NCT03199222

Start date

Mar 29, 2018

Status verified date

Mar, 2019

Completion date

Jul, 2019

Anticipated

Primary completion date

May, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Unilateral transtibial amputation
2. Unilateral revision or reconstruction of transtibial amputation
3. Candidate for intermediate stage (i.e. preparatory) socket fitting
4. Male or female, of any ethnicity
5. 18-60 yrs of age (i.e. active military age)
6. 100-275 lbs.

Exclusion Criteria:

1. Body weight <100 or >275 lbs
2. Does not speak English or Spanish
3. Any other level of amputation than unilateral TTA

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Arm 1: Smart socket technology w/patient prompting

The prosthetic user WILL receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). Investigators will have access to the Smart Socket Technology database.

no intervention: Arm 2: Clinical protocol. No patient prompting

The prosthetic user WILL NOT receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). However, investigators will have access to the Smart Socket Technology database.

Interventions

Prosthetic smart socket technology with patient prompting

The smart socket technology will send feedback to the user's smartphone with suggestions including the removal or application of prosthetic socks over the residual limb or other volume management strategies to improve fit and comfort.

Primary outcome measure

  • Intermediate stage prosthetic complications [ Time Frame: Will be tracked for 120 days. ]
  • Limb volume activity of the residual limb [ Time Frame: Will be tracked for 120 days ]
  • Intermediate stage prosthetic complications (clinical documentation) [ Time Frame: Will be tracked for 120 days ]
  • Intermediate stage prosthetic complications (clinical documentation) [ Time Frame: Will be tracked for 120 days ]

Central Contacts and Locations

Central contacts

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

M. Jason Highsmith, DPT, CP

813-974-3806mhighsmi@health.usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Mar 20, 2019

Last verified

Mar, 2019

Keywords

  • amputation
  • transtibial
  • socket
  • pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2019-03-20.