RecruitingNot ApplicableNCT07448350

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

Transcutaneous Electrical Nerve Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception

Sponsor

Campus Bio-Medico University

Enrollment

15 participants

Start Date

May 5, 2026

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee Lower Limb Amputation Above Knee

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

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 Criteria6

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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Interventions

OTHERTranscutaneal 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.