Transtibial patient for Lower Limb Amputation Below Knee (Injury)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NC State University, Raleigh, NC
Lower Limb Amputation Below Knee (Injury)
Apply ENABLE sensing pad - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limbs accurately. One of the reasons is that there lack of accurate approaches to evaluate the pressure distribution on the residual limb accurately and effectively. To overcome this issue, the research team will develop an innovative sensing system, which permits the prosthetists to track the pressure distribution on the residual limb visually. The capability of the new sensing system will be demonstrated on lower limb amputees.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lower Limb Amputation Below Knee (Injury)

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: The outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials.

Hour 4
Discomfort chart
The outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials.
Pressure distribution on the residual limb

Trial Safety

Safety Progress

1 of 3

Other trials for Lower Limb Amputation Below Knee (Injury)

Trial Design

1 Treatment Group

Transtibial patient
1 of 1
Experimental Treatment

3 Total Participants · 1 Treatment Group

Primary Treatment: Transtibial patient · No Placebo Group · N/A

Transtibial patientExperimental Group · 2 Interventions: Apply ENABLE sensing pad, Insert small pads at pressure tolerant locations · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: the outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials.

Trial Background

Prof. Ming Liu, Research Assistant Professor
Principal Investigator
North Carolina State University
Closest Location: NC State University · Raleigh, NC
N/AFirst Recorded Clinical Trial
1 TrialsResearching Lower Limb Amputation Below Knee (Injury)
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The fibula length on the residual limb must be greater than half of the fibula on the unaffected side.
You have used the socket for at least 6 months without a significant skin issue or major modification.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.