1C70 Feasibility Study

Study Overview
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Brief Summary
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The objective of this study is to characterize the extend of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.

Official Title
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Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New 1C70 Energy Storage and Return Prosthetic Foot

Conditions
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Amputation

Intervention / Treatment
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* Device: 1C70
* Device: Pro-Flex XC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Person is at least 18 years old. Person is a unilateral transtibial amputee with stabilized residual limb. Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL) . Person has at least 6 months experience in walking with a prosthesis. Person is using an energy storage and return (ESR) foot as their primary everyday foot Person has a foot size between 22 and 30. Person weights with a prosthesis between 50 and 125 kg (foot size 26 - 30), or between 45 and 100 kg (foot size 22 - 25). Person wears a prosthesis daily and ≥ 8 hours/day. Person is able to walk at least 500 m without having to make a break. Person is willing and able to independently provide informed consent. Person is willing to comply with study procedures. Exclusion Criteria: Person is pregnant. Person is using a hydraulic foot as their primary everyday foot. Person is using a sport foot (e.g., Fillauer AllPro, Ottobock Challenger, Össur Flex-Foot Cheetah) as their primary everyday foot. Person is using an ESR foot with an integrated vacuum pump (e.g., Ottobock 1C62 Triton Harmony). Person has conditions that would prevent participation and pose increased risk (e.g., unstable cardiovascular conditions that preclude physical activity such as walking). Person falls ≥ once a week due to the reasons that are not related to prosthesis (e.g., problems with vestibular system). Person is not available for study visits during planned study duration. Person is participating in another study or intends to participate in another study during this study´s duration. Person cannot personally provide their consent.

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: 1C70 to Pro-Flex XC<br>Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC | Device: 1C70<br>* Investigational energy storage and return prosthetic foot with using novel elastic elements.<br>Device: Pro-Flex XC<br>* Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects.<br>|
| Experimental: Pro-Flex XC to 1C70<br>Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70 | Device: 1C70<br>* Investigational energy storage and return prosthetic foot with using novel elastic elements.<br>Device: Pro-Flex XC<br>* Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot | The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for everyday foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs. | 2 months after fitting with the last study feet | 
| Extent of meeting amputees prosthetic foot needs: 1C70 vs comparator foot | The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for comparator foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs. | 2 months after fitting with the last study feet | 
| 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. | Baseline measurement vs 2 months after fitting with 1C70 | 
| Change in patient-perceived mobility (PLUS-M) compared to the comparator foot | 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 each of the study feet | 
| Highest pain reported: 1C70 vs everyday foot | The level of pain as a highest pain during preceding 7 days reported on a 0 (No pain at all) to 10 (the most intense pain imaginable) scale for the following origins: residual limb, sound limb, back, shoulder & neck area, phantom limb pain, while wearing the 1C70 foot compared to the everyday foot. | Baseline measurement vs 2 months after fitting with 1C70 | 
| Highest pain reported: 1C70 vs comparator foot | The level of pain as a highest pain during preceding 7 days reported on a 0 (No pain at all) to 10 (the most intense pain imaginable) scale for the following origins: residual limb, sound limb, back, shoulder & neck area, phantom limb pain, while wearing the 1C70 foot compared to the coparator foot. | 2 months after fitting with each of the study feet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputation, transtibial, prosthetic foot