1C70 Feasibility Study

Otto Bock Healthcare Products GmbH22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amputation

Interventions

1C70DEVICE

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Pro-Flex XCDEVICE

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Zentrum für Healthcare Technology der Privaten Hochschule Göttingen (ZHT PFH)

Göttingen, Germany

John+Bamberg

Hanover, Germany

Pohlig Heidelberg

Heidelberg, Germany

UKM ProTec

Münster, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline measurement vs 2 months after fitting with 1C70

Change in patient-perceived mobility (PLUS-M) compared to the comparator foot

Time frame: 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.

Data from ClinicalTrials.gov

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