An interventional study of 1C70 and Pro-Flex XC in Amputation, sponsored by Otto Bock Healthcare Products GmbH. Completed at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Otto Bock Healthcare Products GmbH · Not applicable, Interventional, and Treatment
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.
Otto Bock Healthcare Products GmbH is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC
Device: 1C70 · Device: Pro-Flex XC
Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70
Device: 1C70 · Device: Pro-Flex XC
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects.
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
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: 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.
Time frame: 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.
Time frame: 2 months after fitting with each of the study feet
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.
Time frame: Baseline measurement vs 2 months after fitting with 1C70
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.
Time frame: 2 months after fitting with each of the study feet
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.
Time frame: Baseline measurement vs 2 months after fitting with 1C70
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.
Time frame: 2 months after fitting with each of the study feet
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.
Time frame: Baseline measurement vs 2 months after fitting with 1C70
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.
Time frame: 2 months after fitting with each of the study feet
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)
Time frame: 2 months after fitting with the last study feet
Plan to share: No — There is no plan to share IPD.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Otto Bock Healthcare Products GmbH