TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Recruiting now · Not applicable
Conditions studied: Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
In brief
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.
Key facts
- Study ID
- NCT07448350
- Run by
- Campus Bio-Medico University
- People needed
- 15
- Starts
- 2026-05-05
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Don Gnocchi Foundation — Rome, Rome, Italy (enrolling)
Full record on ClinicalTrials.gov
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