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SoftHand Comparison Study

NCT05328934 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Upper Extremity Injury
  • Upper Extremity Deformities, Congenital
  • Amputation, Traumatic
  • Amputation, Congenital

Interventions

DEVICE

SoftHand Pro

Performance assessments utilizing the SoftHand Pro over an 8-week period.

DEVICE

Ossur i-Limb

Performance assessments utilizing the i-Limb over an 8-week period.

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER

  • Hanger Clinic: Prosthetics & Orthotics

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Marco Santello, Ph.D. · Arizona State University

  • Kristin D. Zhao, Ph.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328934 on ClinicalTrials.gov