TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCampus Bio-Medico University
About this trial
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 criteria
Qualifiers
Age between 18 and 80 years;
unilateral TTA or TFA at least two months prior the study;
stable clinical conditions;
skin integrity;
Disqualifiers
Bilateral amputation;
open wounds or sores on the residual limb;
cognitive deficits;
pregnancy;
Trial design
Treatments tested in this trial
- Transcutaneal Electrical Nerve Stimulation
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Campus Bio-Medico University
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborator
Source ClinicalTrials.gov