Prosthetic Hand Devices for Upper Extremity Amputation

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Sensory, motor medications

Disqualifiers: Recent amputation, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of two different prosthetic hands, the SoftHand Pro and the Ossur i-Limb, for individuals who have lost one arm below the elbow. The study aims to determine which device better assists users in performing everyday tasks over an 8-week period. It is suitable for those who have experienced limb loss for more than 6 months, currently use a myoelectric prosthetic hand, and are comfortable with their device. As an unphased trial, it offers participants the chance to contribute to advancements in prosthetic technology and improve future options for others.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that might affect sensory or motor functions, so you may need to stop taking such medications.

What prior data suggests that these prosthetic hand devices are safe for people with transradial limb loss?

Research shows that the SoftHand Pro is generally well-received. A study involving individuals with upper-limb amputations found it to be safe and effective, with users experiencing improved function without major issues.

The Ossur i-Limb is already well-known in prosthetics. Its strong, motorized fingers and rotating thumb assist many users in daily activities. The i-Limb has a long history of use, with its safety well-proven.

Both prosthetic hands have been used safely in various situations, and users have generally responded positively to them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these prosthetic hand devices because they offer unique approaches to improving functionality and user experience for individuals with upper extremity amputations. The Ossur i-Limb stands out with its advanced multi-articulating finger technology, allowing for more natural hand movements and grip patterns compared to traditional prostheses. Meanwhile, the SoftHand Pro focuses on a softer, more adaptable design that closely mimics the natural flexibility and dexterity of a human hand, potentially making it more comfortable and intuitive for users. These innovations could significantly enhance the quality of life for amputees by providing more realistic and versatile hand functions.

What evidence suggests that these prosthetic hand devices are effective for upper extremity amputation?

This trial will compare two prosthetic hand devices for individuals with upper-limb amputation. Research has shown that the SoftHand Pro, used by participants in one arm of this trial, holds promise for people with upper-limb amputation. Studies indicate it is easy to use and provides accurate, responsive control for everyday tasks. Participants in those studies reported positive experiences, noting improvements in their ability to use and handle objects.

In contrast, the Ossur i-Limb, used by participants in another arm of this trial, is recognized for its advanced technology that allows multiple movements. It helps restore hand functions and enhances users' quality of life. This prosthetic has been tested for effective performance and durability, thanks to its strong titanium construction. Both devices have shown potential in helping people regain hand function and control. ^{4 6 7 8 9}

Who Is on the Research Team?

Marco Santello, Ph.D.

Principal Investigator

Arizona State University

Kristin D. Zhao, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with a stable transradial limb loss who have been using myoelectric prosthetic hands like the Sensor Hand Speed and Bebionic. They should be able to use their current prosthesis effectively. People with limited motion, sensory/motor function issues due to medication, less than 6 months since amputation, or certain neurological conditions are excluded.

Inclusion Criteria

The individual is a user of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic

I can use my prosthesis well, know its parts, and it fits me properly.

I lost one of my arms at the wrist or above, over 6 months ago.

Exclusion Criteria

I have a history of nerve issues in my neck, shoulder, or multiple nerves.

Inability to follow study instructions

I have difficulty moving my joints fully.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SoftHand Pro or Ossur i-Limb for daily activities over an 8-week period

8 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ossur i-Limb
• SoftHand Pro

Trial Overview The study compares two advanced prosthetic hands: SoftHand Pro (SHP) and Ossur i-Limb over an eight-week period in people with arm loss below the elbow. It aims to assess which device performs better in daily tasks.

How Is the Trial Designed?

Group I: Initial Assignment: SoftHand Pro Experimental Treatment 2 Interventions

This arm of the crossover design will begin the trial using the SoftHand Pro.

Group II: Initial Assignment: Ossur i-Limb Active Control 2 Interventions

This arm of the crossover design will begin the trial using the i-Limb.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Hanger Clinic: Prosthetics & Orthotics

Collaborator

Trials

11

Recruited

520+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06452472

Observational Study of People with Complete Hand ... Amputation of upper limb. Observational Study. I-LIMB. multi-grip myoelectric hand prosthesis. function. Plan for Individual Participant Data (IPD). Plan to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11610161/

A performance evaluation of commercially available and ... The Össur i-Limb Quantum (shown in Fig. 2) [16–18] is a CPCA prosthetic hand. Built with titanium digits, the i-Limb Quantum weighs 658 g, has a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12034578/

Functional evaluation of a real-time EMG controlled ... The functional evaluation reveals that ENRICH has the potential to restore functionality to hand amputees, improving their quality of life. Keywords: prosthetic ...

4. ossur.com ossur.com/en-us/prosthetics/upper-limb-training/i-limb

Introduction to i-Limb | Össur Academy Touch Solutions The i-Limb is a multi-articulating myoelectric hand for individuals with upper limb absence at or proximal to the wrist.

5. nature.com nature.com/articles/s41467-025-56352-5

A lightweight prosthetic hand with 19-DOF dexterity and ... Wearable prosthetic hands are deemed the ultimate solution to recover lost hand functions. Despite the development over the past century, ...

6. ossur.com ossur.com/en-us/prosthetics/arms/i-limb-ultra

i-Limb® Ultra It offers an electrically rotating thumb with manual override and has titanium strengthened fingers, which increase the carry load by 50%. Find a Practitioner.

7. ossur.com ossur.com/en-us/prosthetics/arms/i-limb-quantum

i-Limb® Quantum Bionic Hand. Ossur.com The i-Limb Quantum has titanium digits, 50% increased carry load, 30% more grip force, 30% speed boost, gesture control, 5 motorized fingers, and powered thumb.

8. spshangerstore.com spshangerstore.com/i-limb-access-hand-package-1.html

i-LIMB Access Hand Package - Hanger Store Homepage Individually motorized digits with compliant grip and stall-out ability · Manually rotatable thumb that can be positioned between lateral and oppositional mode ...

9. ossur.com ossur.com/en-us/prosthetics/information/information-for-upper-limb-users

Information for Individuals with Upper Limb Difference This section is designed to give you the information you need to understand what upper limb prosthetic solutions are available.