RECRUITING

Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention

Quick Facts

Study Start:2023-12-20
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05656924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral transtibial amputation within the past 4-16 months
  2. * Etiology secondary to complications of Diabetes Mellitus (DM) type II
  3. * Current use of a prosthesis, with at least 2 months prior use
  4. * K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)
  5. * Own a smartphone
  1. * Amputation due to cancer or macrotrauma or acute hemorrhage
  2. * Bilateral amputation
  3. * Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia)
  4. * Severe residual limb pain that limits function preventing participation in an exercise-based program
  5. * Medical conditions that would interfere with subject's participation in regular sustained exercise
  6. * 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)
  7. * Current pregnancy

Contacts and Locations

Study Contact

Paolo Bonato, PhD
CONTACT
617-952-6319
pbonato@mgh.harvard.edu

Principal Investigator

Paolo Bonato, PhD
PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital

Study Locations (Sites)

Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

  • Paolo Bonato, PhD, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-12-20
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabete Type 2
  • Amputation