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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee

Intervention / Treatment
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* Device: Revo-M
* Device: Taleo
* Device: Proflex XC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized cross-over controlled trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-perceived mobility (PLUS-M) compared to baseline | The change from baseline 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. | 2 months after fitting with Revo-M | 
| Change in patient-perceived activity restrictions (TAPES-AR) compared to baseline | The change from baseline level of activity restrictions as measured by the Trinity Amputation and Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR). The TAPES-AR questionnaire provides a score ranging from 0 to 2. A high score is indicative of activity restriction. | 2 months after fitting with Revo-M | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects showing improvement in walking endurance or perceived exertion in the 6-minute Walk Test | The proportion of subjects showing an improvement in 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 Revo-M | 
| Change in patient perceived balance (ABC) compared to baseline | The change from baseline 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. | 2 months after fitting with Revo-M | 
| Change in functional satisfaction with prosthesis (TAPES-FUN) compared to baseline | To characterize the level of functional satisfaction as measured by the TAPES Functional Satisfaction (TAPES-FUN) subscale while wearing the Revo-M compared to the everyday feet. The subscale provides a score that ranges from 5 to 15. Higher scores indicate greater functional satisfaction. | 2 months after fitting with Revo-M | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthetic foot, lower limb amputation