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Prosthetic Device

Prosthetic Hand Devices for Upper Extremity Amputation

N/A
Waitlist Available
Led By Marco Santello, Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial compares the performance of two different devices over an 8-week period in people with transradial limb loss.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not typical side effects as seen with medications, users may experience discomfort, skin irritation from prolonged wear of the prosthesis or difficulty adapting to the new device's functionality.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Upper Extremity
Secondary outcome measures
Hand Motor Function
Occupational Performance
Overall Functional Performance
+5 more
Other outcome measures
Prosthesis User Preference

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Initial Assignment: SoftHand ProExperimental Treatment2 Interventions
This arm of the crossover design will begin the trial using the SoftHand Pro.
Group II: Initial Assignment: Ossur i-LimbActive Control2 Interventions
This arm of the crossover design will begin the trial using the i-Limb.

Find a Location

Who is running the clinical trial?

Arizona State UniversityOTHER
278 Previous Clinical Trials
107,101 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,015 Total Patients Enrolled
Hanger Clinic: Prosthetics & OrthoticsOTHER
9 Previous Clinical Trials
359 Total Patients Enrolled

Media Library

Ossur i-Limb (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05328934 — N/A
Congenital Upper Extremity Deformities Research Study Groups: Initial Assignment: SoftHand Pro, Initial Assignment: Ossur i-Limb
Congenital Upper Extremity Deformities Clinical Trial 2023: Ossur i-Limb Highlights & Side Effects. Trial Name: NCT05328934 — N/A
Ossur i-Limb (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05328934 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be a candidate for this research project?

"This medical trial is selecting 36 participants between the ages of 18 and 70 who were born with upper extremity malformations. In addition, these patients must have had unilateral transradial limb loss for more than 6 months prior to evaluation. Further requirements include proficiency in one or multiple myoelectric prosthetic hands (e.g., Sensor Hand Speed and Bebionic), a successful fitting process through tension analysis, and proper operation of their current prosthesis."

Answered by AI

Are participants being accepted for this medical experiment at present?

"The clinicaltrials.gov website states that this medicinal exploration is not presently seeking participants. Initially posted on April 28th, 2022 and last edited May 11th, 2022; the trial has since suspended recruitment of new volunteers although there are currently 28 other studies recruiting patients."

Answered by AI

Does the enrollment criteria for this experiment include adults above a certain age?

"This trial follows a strict set of inclusion criteria, requiring all participants to be over 18 and under 70 years old."

Answered by AI
~19 spots leftby May 2026