1C70 Feasibility Study

Not Applicable

Completed

• Conditions: Amputation

• Registration Number: NCT05628064
• Lead Sponsor: Otto Bock Healthcare Products GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study Start: 2022-11-24
• Study First Posted: 2022-11-28
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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.

Trial Locations

Locations (6)

Zentrum für Healthcare Technology der Privaten Hochschule Göttingen (ZHT PFH); 🇩🇪 Göttingen, Germany

John+Bamberg; 🇩🇪 Hannover, Germany

Pohlig Heidelberg; 🇩🇪 Heidelberg, Germany

UKM ProTec; 🇩🇪 Münster, Germany

Pohlig Nürnberg; 🇩🇪 Nürnberg, Germany

Pohlig Traunstein; 🇩🇪 Traunstein, Germany