Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot

Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Knee
• Intervention / Treatment: Device: Revo-M; Device: Proflex XC; Device: Taleo

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Artificial Limb Specialists
  • Maryland
    • Linthicum, Maryland, United States, 21090
      • Dankmeyer Prosthetics & Orthotics
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Optimus Prosthetics
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Ability P&O

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revo-M to Proflex XC; Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC	Device: Revo-M; Investigational energy storage and return prosthetic foot with using novel elastic elements.; Device: Proflex XC; Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects
Experimental: Proflex XC to Revo-M; Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M	Device: Revo-M; Investigational energy storage and return prosthetic foot with using novel elastic elements.; Device: Proflex XC; Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects
Experimental: Revo-M to Taleo; Transfemoral amputees randomized to start with Revo-M and cross over to Taleo	Device: Revo-M; Investigational energy storage and return prosthetic foot with using novel elastic elements.; Device: Taleo; Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
Experimental: Taleo to Revo-M; Transfemoral amputees randomized to start with Taleo and cross over to Revo-M	Device: Revo-M; Investigational energy storage and return prosthetic foot with using novel elastic elements.; Device: Taleo; Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-perceived Mobility (PLUS-M)™	Perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility. The T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample. A T-score greater than 57 indicates that the mobility is above the 75th percentile.	baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)	Activity restrictions as measured by the Revised Trinity Amputation and Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR). The TAPES-AR subscale has 10 items on a three-point scale and the average score ranges from 0 to 2. A higher score indicates greater activity restriction.	baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test	The percentage of subjects showing an improvement compared to baseline walking endurance as measured by the distance walked in the six minute walk test OR a decrease in the rating of perceived exertion (RPE) as measured by Borg CR100 while wearing the Revo-M. A clinically-significant improvement in the 6MWT is defined as a change in distance of greater than 45 meters. A clinically-significant improvement in the RPE is defined as a change greater than 10 points. The Borg CR100 scale has a minimum of 0 and a maximum of 100. Greater scores indicate higher perceived exertion.	2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Patient Perceived Balance Confidence (ABC)	Perception of balance confidence as measured by the extended Activities-specific Balance Confidence (ABC) Scale. The questionnaire provides a score that ranges from 0 to 100%. Higher scores indicate greater balance confidence.	baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Functional Satisfaction With Prosthesis (TAPES-FUN)	To characterize the level of functional satisfaction as measured by the TAPES Functional Satisfaction (TAPES-FUN) subscale while wearing a given prosthetic foot. There are 5 items scaled from 1 to 5. The subscale provides a total score that ranges from 5 to 25. Higher scores indicate greater functional satisfaction.	baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Collaborators and Investigators

• Sponsor: Otto Bock Healthcare Products GmbH

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Prosthetic foot, lower limb amputation
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: OB111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No