RECRUITING

Reliability and Validity of Continuous Inter-limb Stability

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

To date, there is no valid and reliable measure of continuous inter-limb stability available to healthcare teams treating people with lower limb loss. Determining these characteristics of this parameter for this population is important because superior stability has been linked to increased physical activity and strength in similar populations, making it a potential vital contributor to mobility improvement of Veterans with limb loss. It is also crucial that healthcare providers can easily measure continuous stability in the clinic instead of relying on expensive laboratory equipment. The overall goals of this study are to determine the reliability and validity of continuous inter-limb stability of Veterans with lower limb loss and determine if this parameter can be captured using accessible wearable technology. Consequently, clinicians can improve continuous stability through proper rehabilitation to positively impact the functional mobility and overall quality of life of Veterans with lower limb loss.

Official Title

Reliability and Validity of Continuous Inter-Limb Stability in Veterans With Lower Limb Loss

Quick Facts

Study Start:2025-04-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06987019

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * any individual with unilateral transtibial limb loss
  2. * a well-fitting prosthesis (as determined by a board-certified prosthetist through standardized prosthetic guidelines) for a minimum of one month
  3. * able to achieve a "Level 6 - Modified Independence" score on the Functional Independence Measure (FIM) for 2 mobility items (locomotion and transfers)
  1. * Individuals with active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair ability to participate in biomechanical evaluations
  2. * any comorbidity that results in rapid limb volume changes (i.e., end stage renal disease with dialysis)
  3. * a poorly fitting socket
  4. * cognitive deficit(s) or mental pathology (e.g., dementia, amnesia) that would prevent the participant from understanding and following directions and limit the participant's ability to participate fully in the study
  5. * women who are pregnant or who plan to become pregnant during their participation in study activities
  6. * FIM scores less than Level 6 for locomotion and transfers

Contacts and Locations

Study Contact

Alexis Sidiropoulos, PhD
CONTACT
(212) 686-7500
alexis.sidiropoulos@va.gov
Jason Maikos, PhD
CONTACT
(212) 686-7500
Jason.Maikos@va.gov

Principal Investigator

Alexis Sidiropoulos, PhD
PRINCIPAL_INVESTIGATOR
VA NY Harbor Healthcare System, New York, NY

Study Locations (Sites)

VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Alexis Sidiropoulos, PhD, PRINCIPAL_INVESTIGATOR, VA NY Harbor Healthcare System, New York, NY

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 Date2025-04-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Transtibial amputation
  • Gait evaluation

Additional Relevant MeSH Terms

  • Amputation, Lower Limb