Prosthetic Hand Devices for Upper Extremity Amputation

Recruiting at 1 trial location

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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.

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 data supports the effectiveness of the treatment Ossur i-Limb, SoftHand Pro for upper extremity amputation?

Research on the SoftHand Pro shows it is a promising prosthetic hand that is easy to use and learn, with users showing significant improvement in performing daily activities like buttoning a shirt and using a cell phone after training. It also highlights the potential of soft robotics and customization to improve user satisfaction by addressing common concerns like weight and cost. ^{1 2 3 4 5}

Is the SoftHand Pro prosthetic hand safe for humans?

The SoftHand Pro prosthetic hand has been evaluated in clinical settings and found to be easy to use and functional, with no significant safety concerns reported during testing with participants who have limb loss. ^{1 2 4 6 7}

How does the treatment with SoftHand Pro differ from other prosthetic hand treatments for upper extremity amputation?

The SoftHand Pro is unique because it uses a single motor and an underactuated design, making it lightweight and cost-effective while maintaining functionality. It combines soft robotics and hand postural synergies, allowing for easy use and adaptability, which can improve user satisfaction compared to traditional prosthetic hands. ^{1 2 8 9 10}

Research Team

Marco Santello, Ph.D.

Principal Investigator

Arizona State University

Kristin D. Zhao, Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The SoftHand Pro: Functional evaluation of a novel, flexible, and robust myoelectric prosthesis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A survey on what Australians with upper limb difference want in a prosthesis: justification for using soft robotics and additive manufacturing for customized prosthetic hands. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

3D-printed custom-designed prostheses for partial hand amputation: Mechanical challenges still exist. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

User-relevant factors determining prosthesis choice in persons with major unilateral upper limb defects: A meta-synthesis of qualitative literature and focus group results. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Staying in Touch: Toward the Restoration of Sensory Feedback in Hand Prostheses Using Peripheral Neural Stimulation. [2017]

6. England pubmed.ncbi.nlm.nih.gov

SoftHand at the CYBATHLON: a user's experience. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The design and development of a gloveless endoskeletal prosthetic hand. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Grasp Performance of a Soft Synergy-Based Prosthetic Hand: A Pilot Study. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The "Federica" Hand. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The SSSA-MyHand: A Dexterous Lightweight Myoelectric Hand Prosthesis. [2018]