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

NCT07448350 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Lower Limb Amputation Above Knee
  • Lower Limb Amputation Below Knee

Interventions

OTHER

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.

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    collaborator OTHER

  • Campus Bio-Medico University

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448350 on ClinicalTrials.gov