Clinical trial NCT05656924: Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Official title: Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabete Type 2
Amputation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Bionic Skins LLC
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-12-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in intra-socket interface pressure between the two groups
timeFrame: Baseline
measure: Difference in step counts between the two groups
timeFrame: 12 months
Secondary outcomes:
measure: Difference in thermal imaging measures of the temperature of the residuum in the two groups
timeFrame: Baseline
measure: Difference in Socket Evaluation Questionnaire (SEQ) scores in the two groups
timeFrame: Baseline
measure: Difference in Prosthesis Evaluation Questionnaire (PEQ) scores in the two groups
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital Boston
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: