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New bionic hand tested against current standard in daily living tasks

NCT ID NCT05328934

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new prosthetic hand, the SoftHand Pro, helps people with below-elbow limb loss perform daily activities better than a commonly used hand, the i-Limb. Thirty-six adults who already use a myoelectric hand took part over 8 weeks. Researchers measured how well they did tasks like picking up objects and using tools.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Apr 2022

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis); 2. the individual had unilateral transradial limb loss more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable; 3. the individual is a proficient owner of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic. Exclusion Criteria: 1. individuals who have had transradial amputation for less than 6 months; 2. individuals who have been fit and trained to use a prosthesis but chose not to use one; 3. individuals who use the i-Limb Quantum myoelectric prosthesis; 4. symptomatic brachial plexopathy, cervical radiculopathy or polyneuropathy (observed); 5. orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed); 6. visual problems that would interfere with the grasping; 7. co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) revealed in medical history; 8. limited range of motion as assessed through range of motion testing; 9. inability to follow study instructions; 10. use of medications that might affect sensory and/or motor functions.

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Conditions

The condition(s) this trial relates to.

amniotic band syndrome Amputation, Congenital Amputation, Traumatic Arm Injuries congenital deformities of limbs congenital limb malformation Upper Extremity Deformities, Congenital

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation, congenital Amputation, traumatic Upper extremity deformities, congenital Upper extremity injury

Contacts and locations

Locations

  • Arizona State University

    Tempe, Arizona, 85281-9709, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.