Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Limb Amputation Below Knee (Injury)
- Sponsor
- Otto Bock Healthcare Products GmbH
- Enrollment
- 26
- Locations
- 4
- Primary Endpoint
- Patient-perceived Mobility (PLUS-M)™
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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
- 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)
- Patient Perceived Balance Confidence (ABC)(baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot)
- Functional Satisfaction With Prosthesis (TAPES-FUN)(baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot)