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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects
Artificial Limb Specialists
Mesa, Arizona, United States
Dankmeyer Prosthetics & Orthotics
Linthicum, Maryland, United States
Optimus Prosthetics
Dayton, Ohio, United States
Ability P&O
Exton, Pennsylvania, United States
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.
Time frame: 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.
Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
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.
Time frame: 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.
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Time frame: 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.
Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot