Clinical trial NCT05628064: 1C70 Feasibility Study
Official title: Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New 1C70 Energy Storage and Return Prosthetic Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: amputation
transtibial
prosthetic foot
Lead sponsor: Otto Bock Healthcare Products GmbH
Sponsor class: INDUSTRY
Collaborators: name: Ottobock SE & Co. KGaA
First posted: 2022-11-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over controlled trial
Primary purpose: TREATMENT

Brief summary: The objective of this study is to characterize the extent 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot
timeFrame: 2 months after fitting with the last study feet
measure: Extent of meeting amputees prosthetic foot needs: 1C70 vs comparator foot
timeFrame: 2 months after fitting with the last study feet
measure: Change in patient-perceived mobility (PLUS-M) compared to baseline
timeFrame: Baseline measurement vs 2 months after fitting with 1C70
measure: Change in patient-perceived mobility (PLUS-M) compared to the comparator foot
timeFrame: 2 months after fitting with each of the study feet
measure: Highest pain reported: 1C70 vs everyday foot
timeFrame: Baseline measurement vs 2 months after fitting with 1C70
measure: Highest pain reported: 1C70 vs comparator foot
timeFrame: 2 months after fitting with each of the study feet
Secondary outcomes:
Other outcomes:
measure: Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs everyday foot
timeFrame: Baseline measurement vs 2 months after fitting with 1C70
measure: Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs comparator foot
timeFrame: 2 months after fitting with each of the study feet
measure: Quality of life as measured by the EQ-5D-5L: 1C70 vs everyday foot
timeFrame: Baseline measurement vs 2 months after fitting with 1C70
measure: Quality of life as measured by the EQ-5D-5L: 1C70 vs comparator foot
timeFrame: 2 months after fitting with each of the study feet
measure: Pain interference: 1C70 vs everyday foot
timeFrame: Baseline measurement vs 2 months after fitting with 1C70
measure: Pain interference: 1C70 vs comparator foot
timeFrame: 2 months after fitting with each of the study feet
measure: Foot preference overall and for use in several specific activities
timeFrame: 2 months after fitting with the last study feet
Locations:
city: Göttingen
country: Germany
facility: Zentrum für Healthcare Technology der Privaten Hochschule Göttingen (ZHT PFH)
city: Hannover
country: Germany
facility: John+Bamberg
city: Heidelberg
country: Germany
facility: Pohlig Heidelberg
city: Münster
country: Germany
facility: UKM ProTec
city: Nürnberg
country: Germany
facility: Pohlig Nürnberg
city: Traunstein
country: Germany
facility: Pohlig Traunstein
Study officials:
References:
citation: Morgan SJ, McDonald CL, Halsne EG, Cheever SM, Salem R, Kramer PA, Hafner BJ. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial. PLoS One. 2018 Feb 7;13(2):e0189652. doi: 10.1371/journal.pone.0189652. eCollection 2018.