1C70 Feasibility Study

NCT05628064 | Completed

• 2 other identifiers: D000002112CIV-22-08-040306
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 6

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.

Conditions

Amputation

Keywords

amputation; transtibial; prosthetic foot

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Other Outcomes (7)

• Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs everyday foot

  Baseline measurement vs 2 months after fitting with 1C70

• Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs comparator foot

  2 months after fitting with each of the study feet

• Quality of life as measured by the EQ-5D-5L: 1C70 vs everyday foot

  Baseline measurement vs 2 months after fitting with 1C70

Study Arms (2)

1C70 to Pro-Flex XC

EXPERIMENTAL

Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC

Device: 1C70; Device: Pro-Flex XC

Pro-Flex XC to 1C70

EXPERIMENTAL

Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70

Device: 1C70; Device: Pro-Flex XC

Interventions

1C70 DEVICE

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

1C70 to Pro-Flex XC; Pro-Flex XC to 1C70

Pro-Flex XC DEVICE

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

1C70 to Pro-Flex XC; Pro-Flex XC to 1C70

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: lead
• Ottobock SE & Co. KGaA: collaborator

Study Sites (6)

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

Göttingen, Germany

Location

John+Bamberg

Hanover, Germany

Location

Pohlig Heidelberg

Heidelberg, Germany

Location

UKM ProTec

Münster, Germany

Location

Pohlig Nürnberg

Nuremberg, Germany

Location

Pohlig Traunstein

Traunstein, Germany

Location

Related Publications (2)

• 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.

  PMID: 29414988 BACKGROUND

• Maciejasz P, Budny T, Sauer M, Umari M, Korber J, Ernst J, Altenburg B, Hahn A, Braatz F. User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial. Prosthet Orthot Int. 2025 Dec 1;49(6):645-653. doi: 10.1097/PXR.0000000000000415. Epub 2024 Dec 4.

  PMID: 39630588 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized cross-over controlled trial

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: November 24, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 28, 2023
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)