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

Not Applicable

Completed

• Conditions: Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Knee
• Interventions: Device: Revo-M; Device: Taleo; Device: Proflex XC

• Registration Number: NCT04239222
• Lead Sponsor: Otto Bock Healthcare Products GmbH

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.

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2020-03-10
• Primary Completion: 2022-03-11
• Study Completion: 2022-03-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Proflex XC to Revo-M	Revo-M	Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M
Taleo to Revo-M	Taleo	Transfemoral amputees randomized to start with Taleo and cross over to Revo-M
Revo-M to Proflex XC	Revo-M	Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC
Revo-M to Proflex XC	Proflex XC	Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC
Proflex XC to Revo-M	Proflex XC	Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M
Taleo to Revo-M	Revo-M	Transfemoral amputees randomized to start with Taleo and cross over to Revo-M
Revo-M to Taleo	Revo-M	Transfemoral amputees randomized to start with Revo-M and cross over to Taleo
Revo-M to Taleo	Taleo	Transfemoral amputees randomized to start with Revo-M and cross over to Taleo

Primary Outcome Measures

Name	Time	Method
Patient-perceived Mobility (PLUS-M)™	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.
Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)	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 Outcome Measures

Name	Time	Method
Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test	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.
Patient Perceived Balance Confidence (ABC)	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.
Functional Satisfaction With Prosthesis (TAPES-FUN)	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.

Trial Locations

Locations (4)

Dankmeyer Prosthetics & Orthotics; 🇺🇸 Linthicum, Maryland, United States

Artificial Limb Specialists; 🇺🇸 Mesa, Arizona, United States

Optimus Prosthetics; 🇺🇸 Dayton, Ohio, United States

Ability P&O; 🇺🇸 Exton, Pennsylvania, United States