## Protocol Section
### Identification Module
**NCT ID:** NCT05112679

**Acronym:** OPORP

**Brief Title:** Limb Health and Socket Pressure in Response to Powered Ankle Protheses

**Official Title:** Limb Health and Socket Pressure in Response to Powered Ankle Prostheses

#### Organization Study ID Info
**ID:** 12350
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2023-07-19

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-03

**Type:** ACTUAL

**Last Update Submit Date:** 2023-09-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-19

**Type:** ACTUAL

#### Start Date
**Date:** 2021-11-15

**Type:** ACTUAL

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2021-11-09
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-13
**Study First Submit QC Date:** 2021-11-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Notre Dame

**Class:** FED

**Name:** United States Department of Defense

#### Lead Sponsor

**Class:** OTHER

**Name:** Indiana University

#### Responsible Party

**Investigator Affiliation:** Indiana University

**Investigator Full Name:** Dr. Sashwati Roy

**Investigator Title:** Professor of Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Pressure Ulcer, Ankle

- Prosthesis User

- Prosthesis Durability

- Mobility Limitation

- Skin Wound

- Amputation; Traumatic, Foot

- Amputation

- Limb Deficiencies

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase

**Intervention Names:**

- Device: PROPRIO FOOT® by Ossur

**Label:** Proprio Foot

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Device: Empower ankle by Ottobock

**Label:** Empower Ankle

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Proprio Foot

**Description:** Active prostheses like the PROPRIO FOOT® offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, perhaps enhancing RTD for military personnel. The investigators will examine factors of socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit. The testing will consist of walking on a treadmill and the use of a 3D motion capture camera to track movement and angles of the participant's upper and lower extremities. Ascending and descending on stairs and ramps with the device will be completed. Participants will also have laser speckle imaging to measure blood flow to skin and transepidermal water loss measurement to check skin health.

**Name:** PROPRIO FOOT® by Ossur

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Empower Ankle

**Description:** Active prostheses -such as the Empower ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, perhaps enhancing RTD for military personnel. The investigators will examine factors of socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit. The testing will consist of walking on a treadmill and the use of a 3D motion capture camera to track movement and angles of the participant's upper and lower extremities. Ascending and descending on stairs and ramps with the device will be completed. Participants will also have laser speckle imaging to measure blood flow to skin and trans epidermal water loss measurement to check skin health.

**Name:** Empower ankle by Ottobock

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** effects of a powered transtibial prosthesis on the socket pressure for level-ground walking, stair ascent/descent, and ramp ascent/descent in comparison to a microprocessor-controlled prosthesis and a passive prosthesis

**Measure:** Effects of use of a powered transtibial prosthesis on socket pressure

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Description:** Changes measured with laser speckle imaging.

**Measure:** Change in Skin Perfusion

**Time Frame:** 4 weeks

**Description:** Water loss change is measured via the TEWL device- the reduction in the score denotes improvement in water loss

**Measure:** Change in transepidermal water loss

**Time Frame:** 4 weeks

**Description:** Change in PEQ-13 score over the course of 4 weeks

**Measure:** Change in PEQ-13 Score

**Time Frame:** 4 weeks

**Description:** Change in Socket Comfort Score over the course of 4 weeks

**Measure:** Socket Comfort Score

**Time Frame:** 4 weeks

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Indianapolis

**Country:** United States

**Facility:** Indiana University Health Methodist Hospital

**State:** Indiana

**Zip:** 46228

#### Overall Officials

**Official 1:**

**Affiliation:** Indiana University

**Name:** Sashwati Roy, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Email study contact

**Description:** The investigators will share deidentified patient data consisting of the patient PEQ and comfort scores and transpepidermal water loss data upon request.

**Info Types:**

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** 6 months after completion

## Document Section

### Large Document Module

#### Large Docs

- Date: 2022-10-25

- Filename: ICF_000.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 253196

- Type Abbrev: ICF

- Upload Date: 2023-08-29T13:43

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M6870

- Name: Pressure Ulcer

- Relevance: HIGH

- As Found: Pressure Ulcer

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M26689

- Name: Mobility Limitation

- Relevance: HIGH

- As Found: Mobility Limitation

- ID: M14338

- Name: Prosthesis Failure

- Relevance: HIGH

- As Found: Prosthesis Durability

- ID: M4009

- Name: Amputation, Traumatic

- Relevance: HIGH

- As Found: Amputation; Traumatic

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003668

- Term: Pressure Ulcer

- ID: D000051346

- Term: Mobility Limitation

- ID: D000011475

- Term: Prosthesis Failure

- ID: D000000673

- Term: Amputation, Traumatic

### Misc Info Module

- Version Holder: 2024-05-24
