Prospective Multicentre Randomized Cross-Over Study Evaluating Specific Function of Upper-Limb Amputee Patients Using the Multi-Grip Myoelectric Hand Prosthesis GEN2 Versus Other Multi-Grip Myoelectric Hand Prostheses
Sponsor study identifier
interventional
20
1 country
1
Study Start
June 13, 2025
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This prospective multicentre randomized cross-over post-market clinical follow-up study compares the TASKA GEN2 multi-grip myoelectric hand prosthesis with marketed comparator prostheses in adults with upper-limb amputation. The study evaluates specific function using the Patient-Specific Functional Scale together with upper-limb function, comfort, quality of life, satisfaction and safety outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2025
Actual (reported)October 4, 2026
Actual (reported)October 15, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Patient-Specific Functional Scale (PSFS).
The Patient-Specific Functional Scale (PSFS) assesses the participant's ability to perform three individually selected daily activities. Each activity is rated from 0 (unable to perform the activity) to 10 (able to perform the activity without restriction). The overall PSFS score is calculated as the mean of the three activity scores, ranging from 0 to 10, with higher scores indicating better functional ability. The outcome is the change in the overall PSFS score from baseline to the end of each 28-day prosthesis wearing period (end-of-period score minus baseline score). The change ranges from -10 to +10, with positive values indicating improvement.
End of each 28-day wearing period
Socket comfort score
End of each 28-day wearing period
Participants use their usual marketed multi-grip myoelectric hand prosthesis during period 1 followed by the TASKA GEN2 prosthesis during period 2 and the optional 8-week extension.
Participants use the TASKA GEN2 prosthesis during period 1 followed by their usual marketed multi-grip myoelectric hand prosthesis during period 2.
Participants use the Taska Gen2 multi-grip myoelectric prosthesis
Participants use their usual marketed multi-grip myoelectric hand prosthesis (Michelangelo or I-Limb Ultra) during the relevant 28-day study period.
Multiple facilities
Multiple Locations, France
Isabelle LOIRET
IRR NANCY
First Submitted
October 4, 2026
First Posted
October 15, 2026
Study Start
June 13, 2025
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Upper limb function using OPUS status
: End of each 28-day wearing period
Upper-limb symptoms and disability using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score.
End of each 28-day wearing period
OPUS Health-Related Quality of Life score at the end of each wearing period
End of each 28-day wearing period
Adjustment to amputation and prosthesis using the Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R).
End of each 28-day wearing period.
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Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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