Trials / Active Not Recruiting
Active Not RecruitingNCT05328934
SoftHand Comparison Study
Toward Use of the Synergy-based SoftHand Pro for Activities of Daily Living by Persons With Transradial Limb Loss: A Multi-site Clinical Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study will measure improvements in outcomes obtained from laboratory testing of the SHP and i-Limb from baseline to after 8 weeks of daily use. A secondary analysis will incorporate the subjects' existing prosthetic hands. Finally, surveys and usage data collected through the SHP and i-Limb firmware during daily use will complement data the aforementioned outcomes to explore factors that may be related to differences in grasping and manipulation performance.
Conditions
- Upper Extremity Injury
- Upper Extremity Deformities, Congenital
- Amputation, Traumatic
- Amputation, Congenital
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-04-28
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2022-04-14
- Last updated
- 2025-10-14
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05328934. Inclusion in this directory is not an endorsement.