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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception

RecruitingNAAges 18 Years - 80 YearsAllCampus Bio-Medico University
NCT07448350 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the study is to evaluate the changes induced by a course of Transcutaneous Electrical Nerve Stimulation (TENS) treatment on the perception of phantom limb pain. In particular, we want to evaluate the changes induced by a course of TENS treatment on posture, balance, and gait. For each patient, the study will consist of a total of 20 sessions (4 mapping sessions, 3 Stimulus Intensity Discrimination sessions, 10 rehabilitation treatments, and 3 evaluation sessions). One session will be carried out each day. Each session will last 60 minutes, except for the evaluation sessions, which are expected to last approximately 90 minutes. For the patient, the study ends with the last evaluation, voluntary withdrawal from the study, or the patient's death.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 80 years; * unilateral TTA or TFA at least two months prior the study; * stable clinical conditions; * skin integrity; * absence of cognitive deficits; * able to walk using the prosthesis; * no previous experience with TENS. Exclusion Criteria: * Bilateral amputation; * open wounds or sores on the residual limb; * cognitive deficits; * pregnancy; * presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps); * refusal to sign the informed consent.
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What it tests

  • Transcutaneal Electrical Nerve Stimulation
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Where

1 site
Don Gnocchi Foundation
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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