Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Unilateral transtibial amputation within the past 4-16 months
• Etiology secondary to complications of Diabetes Mellitus (DM) type II
• Current use of a prosthesis, with at least 2 months prior use
• K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)
• Own a smartphone
Locations
United States
Massachusetts
Spaulding Rehabilitation Hospital Boston
RECRUITING
Boston
Contact Information
Primary
Paolo Bonato, PhD
pbonato@mgh.harvard.edu
617-952-6319
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 38
Treatments
Experimental: digital prosthetic interface technology group
Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.
No_intervention: traditional socket and liner technology group
Study participants randomized to this group will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).
Related Therapeutic Areas
Sponsors
Leads: Spaulding Rehabilitation Hospital
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bionic Skins LLC