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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Sponsor: Campus Bio-Medico University
Summary
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.
Official title: Transcutaneous Electrical Nerve Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-03-01
Completion Date
2027-12-31
Last Updated
2026-03-04
Healthy Volunteers
No
Interventions
Transcutaneal Electrical Nerve Stimulation
Each patient will undergo two 60-minute sessions per day, except for the evaluation ones which are expected to last approximately 90 minutes, five days per week for a total duration of 4 weeks. 1. Mapping sessions: Four Mapping sessions performed at the beginning of each week. 2. Stimulus Intensity Discrimination sessions: Three Stimulus Intensity Discrimination sessions will be conducted over three consecutive days during the first week. 3. Rehabilitative sessions: Ten rehabilitative sessions aimed at re-educating walking in controlled and repeatable experimental conditions while simultaneously using the device with either technological solutions or proprioceptive exercises will be carried out. 4. Evaluation sessions: Three evaluation sessions will be performed at the beginning (T0), in the middle (T1) and at the end (T2) of the experimental protocol.
Locations (1)
Don Gnocchi Foundation
Rome, Rome, Italy