Skip to main content
OpenTrials
Completed

NCT Number: NCT04239222

Feasibility Study to Evaluate 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Knee Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Artificial Limb Specialists, Mesa, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Current prosthetic foot is too old or worn out as assessed by the CPO.
  • TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
  • Patient is pregnant or planning to become pregnant.
  • Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
  • 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.).
  • Ulceration or skin breakdown of the residual limb.
  • Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.

Treatment and study plan

Revo-M

Device

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Taleo

Device

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects

Proflex XC

Device

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Primary outcomes

  1. Patient-perceived Mobility (PLUS-M)™

    Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

    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.

  2. Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)

    Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

    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.

Secondary outcomes

  1. Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test

    Time frame: 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

    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. Patient Perceived Balance Confidence (ABC)

    Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

    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.

  3. Functional Satisfaction With Prosthesis (TAPES-FUN)

    Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

    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.

Sponsors and collaborators

Lead sponsor

Otto Bock Healthcare Products GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.