1C70 Feasibility Study
- Conditions
- Amputation
- Interventions
- Device: 1C70Device: Pro-Flex XC
- Registration Number
- NCT05628064
- Lead Sponsor
- Otto Bock Healthcare Products GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pro-Flex XC to 1C70 Pro-Flex XC Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70 1C70 to Pro-Flex XC 1C70 Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC 1C70 to Pro-Flex XC Pro-Flex XC Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC Pro-Flex XC to 1C70 1C70 Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70
- Primary Outcome Measures
Name Time Method Highest pain reported: 1C70 vs everyday foot Baseline measurement vs 2 months after fitting with 1C70 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.
Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot 2 months after fitting with the last study feet 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.
Extent of meeting amputees prosthetic foot needs: 1C70 vs comparator foot 2 months after fitting with the last study feet 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.
Change in patient-perceived mobility (PLUS-M) compared to baseline Baseline measurement vs 2 months after fitting with 1C70 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.
Change in patient-perceived mobility (PLUS-M) compared to the comparator foot 2 months after fitting with each of the study feet 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.
Highest pain reported: 1C70 vs comparator foot 2 months after fitting with each of the study feet 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
John+Bamberg
🇩🇪Hannover, Germany
Zentrum für Healthcare Technology der Privaten Hochschule Göttingen (ZHT PFH)
🇩🇪Göttingen, Germany
Pohlig Heidelberg
🇩🇪Heidelberg, Germany
UKM ProTec
🇩🇪Münster, Germany
Pohlig Nürnberg
🇩🇪Nürnberg, Germany
Pohlig Traunstein
🇩🇪Traunstein, Germany