1C70 Feasibility Study

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05628064
• Other study ID #: D000002112
• Secondary ID: CIV-22-08-040306
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Otto Bock Healthcare Products GmbH
• Contact: Pawel Maciejasz, PhD
• Phone: +4915158264176
• Email: pawel.maciejasz[@]ottobock.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• 1C70
Investigational energy storage and return prosthetic foot with using novel elastic elements.
• Pro-Flex XC
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects.

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Otto Bock Healthcare Products GmbH	Ottobock SE & Co. KGaA

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs everyday foot	Perception of balance confidence as measured by the Activities-specific Balance Confidence (ABC) Scale. The questionnaire provides a score that ranges from 0 to 100%. Higher scores indicate greater balance confidence.	Baseline measurement vs 2 months after fitting with 1C70
Other	Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs comparator foot	Perception of balance confidence as measured by the Activities-specific Balance Confidence (ABC) Scale. The questionnaire provides a score that ranges from 0 to 100%. Higher scores indicate greater balance confidence.	2 months after fitting with each of the study feet
Other	Quality of life as measured by the EQ-5D-5L: 1C70 vs everyday foot	Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. These weights, sometimes referred to as 'utilities', are often used to compute QALYs for use in health economic analyses. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.	Baseline measurement vs 2 months after fitting with 1C70
Other	Quality of life as measured by the EQ-5D-5L: 1C70 vs comparator foot	Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. These weights, sometimes referred to as 'utilities', are often used to compute QALYs for use in health economic analyses. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.	2 months after fitting with each of the study feet
Other	Pain interference: 1C70 vs everyday foot	Perception of pain interference on the usual activities as measured by a single question with a 0 ("Does not interfere") to 10 ("Completely interferes") scale.	Baseline measurement vs 2 months after fitting with 1C70
Other	Pain interference: 1C70 vs comparator foot	Perception of pain interference on the usual activities as measured by a single question with a 0 ("Does not interfere") to 10 ("Completely interferes") scale.	2 months after fitting with each of the study feet
Other	Foot preference overall and for use in several specific activities	Foot preference overall and for use in several specific activities as measured by a questionnaire from the publication of Morgan et al. (Morgan et al. 2018)	2 months after fitting with the last study feet
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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