Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Purpose
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.
Conditions
- Diabete Type 2
- Amputation
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- Amputation due to cancer or macrotrauma or acute hemorrhage - Bilateral amputation - Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia) - Severe residual limb pain that limits function preventing participation in an exercise-based program - Medical conditions that would interfere with subject's participation in regular sustained exercise - Anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device used to scan the residuum) - Current pregnancy
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Study participants will be randomized to one of two groups: group 1 will use the digital prosthetic interface technology developed by Bionic Skins and group 2 will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
Boston, Massachusetts 02129
More Details
- Status
- Recruiting
- Sponsor
- Spaulding Rehabilitation Hospital
Detailed Description
The study will test the hypothesis that the use of a digital approach to the design and implementation of socket and liner technology (herein referred to as "digital prosthetic interface technology") leads to better health of the residuum (compared to traditional socket and liner technology). This hypothesis will be tested by recruiting a group of dysvascular amputees (herein meant to refer to individuals who lost a lower limb secondary diabetes mellitus type II) and by randomizing them to either receiving a digital prosthetic interface technology or a traditional socket and liner system. Furthermore, the study will assess if the digital prosthetic interface technology improves adherence to an exercise program and results in better clinical outcomes. To test this hypothesis, an exercise intervention will be deployed by relying on coaching and mobile health technology to encourage adherence to a walking program targeting dysvascular transtibial amputees. This exercise intervention is an extension of pilot work that demonstrated the suitability of mobile health technology to implement an exercise-based intervention program in dysvascular amputees.