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Search / Trial NCT05126485

Biofeedback Retention in Individuals With AKA

Launched by SAN JOSE STATE UNIVERSITY · Nov 8, 2021

Trial Information

Current as of June 28, 2025

Recruiting

Keywords

Biofeedback Amputation Gait Osteoarthritis

ClinConnect Summary

This clinical trial is exploring the use of biofeedback to help individuals with above-knee amputations improve their walking patterns. Biofeedback is a technique that uses wearable sensors to track the movements of patients in real-time. When patients walk, the system gives them feedback through gentle vibrations on their skin, letting them know when they reach the right movements. The goal is to see if this method can help patients learn to walk more effectively and whether those improvements last even after the training is done.

To be eligible for the study, participants must have had a leg amputation between the knee and hip at least a year ago and have experience walking with their current prosthetic leg for at least three months. They should be able to walk for at least 25 minutes with little rest and be classified as community ambulators (K2 and K3 levels). Participants can expect to undergo a single session of biofeedback training, where researchers will measure their walking ability before, during, and after the training. This research may lead to new ways for patients to continue their rehabilitation at home, making it easier for them to access care and improve their mobility.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Unilateral limb amputation occurring between the knee and hip joints
  • Minimum of one-year post-amputation and should have at least three-months experience walking with their current prosthetic system.
  • Classified as K2 and K3-level community ambulators will be included in the study.
  • Able to walk a minimum of 25 minutes with minimal rest. For participants with vascular-related amputations, a doctor's note clearing them to participate in the study will be required.
  • Able to understand and speak English.
  • Exclusion Criteria:
  • Previous spinal cord injury, stroke, or traumatic brain injury.
  • Major upper-limb loss, defined as an amputation occurring proximal to the wrist.
  • Previous or current injury affecting the function of their intact limb (e.g. pelvic injury, osteoarthritis, etc.)
  • Significant hip contracture exceeding 15°
  • Body-mass-index exceeding 35

About San Jose State University

San Jose State University (SJSU) is a leading public research institution located in the heart of Silicon Valley, dedicated to advancing knowledge and innovation in various fields, including health and medicine. With a strong commitment to fostering academic excellence and community engagement, SJSU conducts clinical trials that aim to contribute to the understanding of health-related issues and develop effective interventions. The university's collaborative approach brings together interdisciplinary teams of researchers, healthcare professionals, and students, ensuring rigorous methodology and ethical standards in all clinical research endeavors. Through these trials, SJSU seeks to translate research findings into practical solutions that enhance patient care and promote public health.

Locations

San Francisco, California, United States

Palo Alto, California, United States

San Francisco, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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