Upper Limb AmputationNCT07876115
Cross-Over Study Evaluating the TASKA GEN2 Myoelectric Hand Prosthesis
A study testing TASKA GEN2 Multi-Grip Myoelectric Hand Prosthesis and Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesis in people with Upper Limb Amputation and Transradial Amputation, run by TASKA Prosthetics at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Amputation, Transradial Amputation, Transhumeral Amputation
- What is being tested?
- TASKA GEN2 Multi-Grip Myoelectric Hand Prosthesis and Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (>18 years).
- Unilateral acquired or congenital transradial or transhumeral amputation or elbow disarticulation.
- Using Michelangelo or I-Limb Ultra prosthesis for >2 months.
- Prosthesis use >6 hours/day.
- Written informed consent.
Who cannot join
- Bilateral upper-limb amputation.
- Shoulder disarticulation.
- Lower-limb amputation.
- Temporary prosthesis.
- Major expected routine activity change.
- Progressive pathology preventing follow-up.
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- Pregnancy.
- Protected/vulnerable adults.
- No health insurance affiliation.
- Unable to understand study instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Multiple facilities
Multiple Locations
Emma Blundell Emma, +64 22 571 1479, emma.blundell@taskaprosthetics.com
About this study
Official title: 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
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.
Read the detailed description
Upper-limb amputation significantly impairs daily activities and quality of life. Multi-grip myoelectric hand prostheses may improve upper-limb function compared with standard prostheses. This study compares the CE-marked TASKA GEN2 prosthesis with marketed comparator prostheses (Michelangelo or I-Limb Ultra) in a randomized cross-over design with two 28-day wearing periods. Patients randomized to receive GEN2 during period 2 will additionally continue using GEN2 for 8 weeks to provide longer-term descriptive data. The primary endpoint is the change in Patient-Specific Functional Scale score at the end of each wearing period compared with baseline.
- Being tested
- TASKA GEN2 Multi-Grip Myoelectric Hand Prosthesis, Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesis
- Keywords
- myoelectric prosthesis, upper limb amputation, TASKA GEN2, prosthetic hand, PSFS, OPUS, QuickDASH, TAPES-R, QUEST, SHAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASKA GEN2 Multi-Grip Myoelectric Hand ProsthesisDevice
Participants use the Taska Gen2 multi-grip myoelectric prosthesis
Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesisDevice
Participants use their usual marketed multi-grip myoelectric hand prosthesis (Michelangelo or I-Limb Ultra) during the relevant 28-day study period.
| Study group | Role | What they receive |
|---|---|---|
| Usual Prosthesis Followed by TASKA GEN2 | Other | 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. Receives: Device: TASKA GEN2 Multi-Grip Myoelectric Hand Prosthesis; Device: Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesis |
| TASKA GEN2 Followed by Usual Prosthesis | Other | Participants use the TASKA GEN2 prosthesis during period 1 followed by their usual marketed multi-grip myoelectric hand prosthesis during period 2. Receives: Device: TASKA GEN2 Multi-Grip Myoelectric Hand Prosthesis; Device: Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of each 28-day wearing period
Secondary outcomes (10)
Socket comfort score
Comfort assessed on an 11-point numeric scale from 0 (most uncomfortable socket imaginable) to 10 (most comfortable socket imaginable)
Measured: End of each 28-day wearing period
Upper limb function using OPUS status
OPUS Upper Extremity Functional Status module assesses the participant's perceived ease in performing activities of daily living with the prosthesis. Item responses generate an OPUS raw score, which will be converted according to the OPUS Scoring Guide to a Rasch measure on a 0-to-100 scale. Higher Rasch scores indicate better perceived upper-limb function.
Measured: : End of each 28-day wearing period
Upper-limb symptoms and disability using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score.
The QuickDASH is an 11-item questionnaire assessing symptoms and functional limitations involving the upper limb. Items are rated from 1 (best) to 5 (worst). The score is transformed to a 0-to-100 scale; higher scores indicate greater disability
Measured: End of each 28-day wearing period
OPUS Health-Related Quality of Life score at the end of each wearing period
The 23-item OPUS Health-Related Quality of Life component assesses health-related quality of life. Item responses generate a raw score ranging from 0 to 92, which will be converted according to the OPUS Scoring Guide to a Rasch measure on a 0-to-100 scale. Higher Rasch scores indicate better health-related quality of life.
Measured: End of each 28-day wearing period
Adjustment to amputation and prosthesis using the Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R).
The 33-item TAPES-R assesses three domains: psychosocial adjustment (15 items, rated 1 to 4; higher scores indicate better adjustment), activity restriction (10 items, rated 0 to 2; higher scores indicate greater limitation), and satisfaction with the prosthesis (8 items, rated 1 to 3; higher scores indicate greater satisfaction). Psychosocial adjustment includes general, social, and adjustment-to-limitation subscales; prosthesis satisfaction includes aesthetic and functional subscales.
Measured: End of each 28-day wearing period.
Satisfaction with the prosthesis using the Evaluation de la Satisfaction envers une Aide Technique (ESAT), French version of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST).
The ESAT/QUEST contains 12 items rated from 1 (not satisfied at all) to 5 (very satisfied): 8 items assess satisfaction with the technology and 4 assess satisfaction with related services. The total score and the two component scores will be calculated. The summed total score ranges from 12 to 60, with higher scores indicating greater satisfaction. Sources of dissatisfaction are also recorded qualitatively.
Measured: End of each 28-day wearing period.
Number of Participants Preferring TASKA GEN2 or Their Usual Myoelectric Hand Prosthesis
At the end of the comparative cross-over phase, participants are asked to indicate which of the two multi-grip myoelectric hand prostheses they prefer: TASKA GEN2 or their usual prosthesis (Michelangelo or I-Limb Ultra).
The number and percentage of participants preferring each prosthesis will be reported. Percentages will be calculated based on the number of participants who completed the preference assessment.
Measured: End of period 2 (after two 28-day wearing periods).
Number of days of prosthesis unavailability.
For each prosthesis wearing period, the number of days during which the allocated prosthesis is unavailable for use is recorded.
Measured: During each 28-day wearing period.
Number and description of adverse events, serious adverse events, and device deficiencies.
Safety is assessed by recording adverse events, serious adverse events, and device deficiencies occurring during study participation. The number and detailed description of events and deficiencies will be reported.
Measured: From enrollment through the participant's final study visit; up to approximately 16 weeks for participants entering the 8-week GEN2 extension
Hand function using the Southampton Hand Assessment Procedure (SHAP) (optional, at centres with SHAP scoring software)
The SHAP is a clinically validated, timed hand-function test comprising 26 tasks (abstract objects and activities of daily living), each classified into one of six prehensile patterns. Task times are normalised to generate a SHAP Index of Function and a Functionality Profile. A score of 100 corresponds to normal hand function; lower scores indicate greater impairment, and scores above 100 are possible
Measured: End of each 28-day wearing period]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start13 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TASKA Prosthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle LOIRET, Principal investigator, IRR NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876115
- Sponsor's protocol ID
- 2024-A02363-44
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No