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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Don Gnocchi Foundation
RECRUITING
Rome
Time Frame
Start Date: 2026-05-05
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 15
Treatments
Experimental: TENS Group
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione Don Carlo Gnocchi Onlus
Leads: Campus Bio-Medico University

This content was sourced from clinicaltrials.gov