Limb Health and Socket Pressure in Response to Powered Ankle Protheses (OPORP)
Primary Purpose
Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROPRIO FOOT® by Ossur
Empower ankle by Ottobock
Sponsored by
About this trial
This is an interventional supportive care trial for Pressure Ulcer, Ankle
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
Sites / Locations
- Indiana University Health Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Proprio Foot
Empower Ankle
Arm Description
microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase
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
Outcomes
Primary Outcome Measures
Effects of use of a powered transtibial prosthesis on socket pressure
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
Secondary Outcome Measures
Change in Skin Perfusion
Changes measured with laser speckle imaging.
Change in transepidermal water loss
Water loss change is measured via the TEWL device- the reduction in the score denotes improvement in water loss
Change in PEQ-13 Score
Change in PEQ-13 score over the course of 4 weeks
Socket Comfort Score
Change in Socket Comfort Score over the course of 4 weeks
Full Information
NCT ID
NCT05112679
First Posted
August 13, 2021
Last Updated
September 29, 2023
Sponsor
Indiana University
Collaborators
University of Notre Dame, United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT05112679
Brief Title
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
Acronym
OPORP
Official Title
Limb Health and Socket Pressure in Response to Powered Ankle Prostheses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
July 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
University of Notre Dame, United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability, Mobility Limitation, Skin Wound, Amputation; Traumatic, Foot, Amputation, Limb Deficiencies
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proprio Foot
Arm Type
Active Comparator
Arm Description
microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase
Arm Title
Empower Ankle
Arm Type
Active Comparator
Arm 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 Type
Device
Intervention Name(s)
PROPRIO FOOT® by Ossur
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Empower ankle by Ottobock
Intervention 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.
Primary Outcome Measure Information:
Title
Effects of use of a powered transtibial prosthesis on socket pressure
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Skin Perfusion
Description
Changes measured with laser speckle imaging.
Time Frame
4 weeks
Title
Change in transepidermal water loss
Description
Water loss change is measured via the TEWL device- the reduction in the score denotes improvement in water loss
Time Frame
4 weeks
Title
Change in PEQ-13 Score
Description
Change in PEQ-13 score over the course of 4 weeks
Time Frame
4 weeks
Title
Socket Comfort Score
Description
Change in Socket Comfort Score over the course of 4 weeks
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sashwati Roy, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46228
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will share deidentified patient data consisting of the patient PEQ and comfort scores and transpepidermal water loss data upon request.
IPD Sharing Time Frame
6 months after completion
IPD Sharing Access Criteria
Email study contact
Learn more about this trial
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
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