Using digital prosthetic technology and exercise for dysvascular amputees
Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention
This study is testing a new digital prosthetic for people who have lost a leg below the knee due to diabetes, along with an exercise program, to see if it helps them feel better and stay active.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05656924 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a new digital prosthetic interface technology designed for individuals who have undergone unilateral transtibial amputation due to complications from type 2 diabetes. Participants will be randomized to receive either the digital prosthetic technology or a traditional socket and liner system. The study will also implement an exercise program supported by mobile health technology to enhance adherence and improve health outcomes. The effectiveness of this combined approach will be assessed through various clinical measures over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals with unilateral transtibial amputation due to type 2 diabetes, who have been using a prosthesis for at least two months and own a smartphone.
Not a fit: Patients with bilateral amputations or those whose amputation was due to cancer or trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes and quality of life for dysvascular amputees.
How similar studies have performed: Other studies have shown promise in using technology-based interventions for improving outcomes in amputees, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Spaulding Rehabilitation Hospital Boston — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Paolo Bonato, PhD — Spaulding Rehabilitation Hospital
- Study coordinator: Paolo Bonato, PhD
- Email: pbonato@mgh.harvard.edu
- Phone: 617-952-6319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.