Clinical trial NCT04239222: Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
Official title: Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation Below Knee (Injury)
Lower Limb Amputation Above Knee (Injury)
Lower Limb Amputation Knee
Keywords: Prosthetic foot, lower limb amputation
Lead sponsor: Otto Bock Healthcare Products GmbH
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over controlled trial
Primary purpose: TREATMENT

Brief summary: A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.

Detailed description: The purpose of the Revo-M Study is to characterize differences in performance and patient reported outcomes between the Revo investigational prosthetic foot and a comparative prosthetic foot (Taleo or Proflex XC) when compared to the control foot which is the subject's currently used energy storage and return (ESR) prosthetic foot. The data obtained from this study may also serve to determine the long-term performance of Revo.

Eligibility criteria: Inclusion Criteria:

1. Person is 18 years or older.
2. Currently uses an energy storage and return foot.
3. Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
4. For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
5. Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
6. Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).
7. Prosthetic foot size is 24 to 27 centimeters.
8. Socket Comfort Score of at least 7
9. Ability to read and understand English
10. A person is able and willing to give consent

Exclusion Criteria:

1. Current prosthetic foot is too old or worn out as assessed by the CPO.
2. TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
3. Patient is pregnant or planning to become pregnant.
4. Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
5. Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.).
6. Ulceration or skin breakdown of the residual limb.
7. Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.

Primary outcomes:
measure: Patient-perceived Mobility (PLUS-M)™
timeFrame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
measure: Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)
timeFrame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Secondary outcomes:
measure: Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test
timeFrame: 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
measure: Patient Perceived Balance Confidence (ABC)
timeFrame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
measure: Functional Satisfaction With Prosthesis (TAPES-FUN)
timeFrame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Artificial Limb Specialists
state: Arizona
city: Linthicum
country: United States
facility: Dankmeyer Prosthetics & Orthotics
state: Maryland
city: Dayton
country: United States
facility: Optimus Prosthetics
state: Ohio
city: Exton
country: United States
facility: Ability P&O
state: Pennsylvania
Study officials:
References:
citation: Gallagher P, Franchignoni F, Giordano A, MacLachlan M. Trinity amputation and prosthesis experience scales: a psychometric assessment using classical test theory and rasch analysis. Am J Phys Med Rehabil. 2010 Jun;89(6):487-96. doi: 10.1097/PHM.0b013e3181dd8cf1.
citation: Hafner BJ, Morgan SJ, Askew RL, Salem R. Psychometric evaluation of self-report outcome measures for prosthetic applications. J Rehabil Res Dev. 2016;53(6):797-812. doi: 10.1682/JRRD.2015.12.0228.