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Limb Health and Socket Pressure in Response to Powered Ankle Protheses

Limb Health and Socket Pressure in Response to Powered Ankle Prostheses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05112679
Acronym
OPORP
Enrollment
6
Registered
2021-11-09
Start date
2021-11-15
Completion date
2023-07-19
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEPROPRIO 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.

Sponsors

University of Notre Dame
CollaboratorOTHER
United States Department of Defense
CollaboratorFED
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Powered Transtibial Prosthesis on Socket Pressure4 weekseffects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis

Secondary

MeasureTime frameDescription
Change in Skin Perfusion4 weeksChanges measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome.
Transepidermal Water Loss (TEWL)4 weeksWater loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.

Countries

United States

Participant flow

Participants by arm

ArmCount
Proprio Foot, Then Empower Ankle
Participants started with the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. After four weeks of use, participants crossed over to use the Empower ankle by Ottobock, an active powered ankle prosthesis, for an additional four weeks.
3
Empower Ankle, Then Proprio Foot
Participants started with the Empower ankle by Ottobock, an active powered ankle prosthesis. After four weeks of use, participants crossed over to use the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for an additional four weeks.
3
Total6

Baseline characteristics

CharacteristicProprio Foot, Then Empower AnkleEmpower Ankle, Then Proprio FootTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
3 Participants3 Participants6 Participants
participants completed the study visits3 Participants3 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants3 Participants5 Participants
Region of Enrollment
United States
3 Participants3 Participants6 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
3 Participants3 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 6
other
Total, other adverse events
0 / 60 / 6
serious
Total, serious adverse events
0 / 60 / 6

Outcome results

Primary

Powered Transtibial Prosthesis on Socket Pressure

effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis

Time frame: 4 weeks

Population: accurate in-socket pressure data could be only collected from 3 subjects

ArmMeasureValue (MEAN)Dispersion
Proprio FootPowered Transtibial Prosthesis on Socket Pressure0.58 kPa/kgStandard Deviation 0.01
Empower AnklePowered Transtibial Prosthesis on Socket Pressure0.25 kPa/kgStandard Deviation 0.03
Comparison: All participants were randomized to both groups in a cross over design, if a participant started with proprio after 4 weeks of use they will cross over to Empower ankle or vice versa. the data reflect comparison of the groups.p-value: 0.009Wilcoxon (Mann-Whitney)
Secondary

Change in Skin Perfusion

Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome.

Time frame: 4 weeks

Population: accurate data only from n=4 participants were obtained in Empower foot.

ArmMeasureValue (MEAN)Dispersion
Proprio FootChange in Skin Perfusion1.1 Perfusion Units (PU)Standard Deviation 0.75
Empower AnkleChange in Skin Perfusion0.8 Perfusion Units (PU)Standard Deviation 0.7
Secondary

Transepidermal Water Loss (TEWL)

Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
Proprio FootTransepidermal Water Loss (TEWL)2.0 g/m^2 x hStandard Deviation 0.61
Empower AnkleTransepidermal Water Loss (TEWL)0.8 g/m^2 x hStandard Deviation 0.21

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026