Limb Health and Socket Pressure in Response to Powered Ankle Protheses

NCT ID: NCT05112679

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2023-07-19

Brief Summary

this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.

Detailed Description

Some estimates suggest that by 2050, as many as 3.6 million people in the United States will be living with limb loss, and at least 60% of them will have had at least a foot removed For military personnel, combat-related amputations remain one of the most common major disabling war-related injuries from modern armed conflict. Technological advancements in active prosthetic devices for individuals with transtibial amputation offer the potential for superior function in key areas that could lead to higher rates of RTD and improved quality of life. Currently intended primarily for individuals with a K-level of 3 or 4, active transtibial prostheses that provide controlled plantar/dorsiflexion in either swing (microprocessor-controlled prostheses) or late stance (prostheses with powered propulsion) are likely to become the gold standard in the future as technology continues to improve Indeed, users of these types of prostheses have higher mobility than those using any of the other four categories of prosthetic ankle-foot mechanisms for unlimited community ambulators. Note that a major insurer has recently declared microprocessor-controlled ankle-foot prostheses medically necessary for members whose functional level is 3 or above.The PROPRIO FOOT® by Ossur, is a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. This added ankle control of these devices reduces the risk of falls by increasing toe clearance supports more natural standing posture on slopes and improves stair and slope ascent/descent capability by adapting to the change in terrain. On stairs, the PROPRIO FOOT® has been shown to improve affected leg knee kinematics (increased knee flexion) and kinetics (increased knee moment) instance. These improvements also contributed to higher interlimb symmetry reduced energetic cost of slope ascent and higher Amputee Mobility Predictor with a Prosthesis (AMPPRO) scores . Although the ankle of the PROPRIO FOOT® can be controlled in swing, the device does not have adequate power to provide an active propulsion instance. The Empower ankle by Ottobock is a powered prosthesis that provides active propulsion in late stance to mimic the positive work performed by the ankle plantar flexors in push-off. The Empower has been shown to improve affected leg kinematics (increased ankle range of motion and reduced knee flexion) on smooth flat ground ramp ascent and gravel]. In terms of kinetics, the Empower likewise results in increased ankle power on level ground stairs and ramps . Active prostheses like the PROPRIO FOOT® and Empower ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, perhaps enhancing RTD for military personnel. As with all prosthetic components, though, these active devices are of little use if they induce pain and/or injury at the residual limb to the degree that the user will simply not wear them. The investigators will examine how optimal fit of lower limb prostheses can impact individuals comfort and/or reduce irritation.

Conditions

Pressure Ulcer, Ankle; Prosthesis User; Prosthesis Durability; Mobility Limitation; Skin Wound; Amputation; Traumatic, Foot; Amputation; Limb Deficiencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Proprio Foot

each participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio

Group Type: EXPERIMENTAL

PROPRIO FOOT® by Ossur & Empower ankle by Ottobock

Intervention Type: DEVICE

PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.

Empower foot

ach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio

Group Type: EXPERIMENTAL

PROPRIO FOOT® by Ossur & Empower ankle by Ottobock

Intervention Type: DEVICE

PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.

Interventions

PROPRIO FOOT® by Ossur & Empower ankle by Ottobock

PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages 18 and above
• Weight ≤ 280 lb
• Ambulate at a K3 level or higher-level determined from patient EHR
• At least 3 months post-amputation per physician discretion
• Residual limb length greater than 4.5 inches
• Use of a passive prosthesis
• Unilateral transtibial amputees
• Must be able to ambulate without any assistive devices
• Subjects must be able to follow directions and give informed consent on their own

Exclusion Criteria

• Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb
• Other amputees
• Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
• Women who are pregnant or who plan to become pregnant in the near future
• Individuals diagnosed with renal failure
• Participants unwilling to wear a cloth face covering for the duration of each visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Notre Dame

OTHER

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sashwati Roy

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sashwati Roy, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

12350

Identifier Type: -

Identifier Source: org_study_id