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New treatment option for Lower Limb Amputation Above Knee
Official title TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
ClinicalTrials.gov ID: NCT07448350
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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;
You likely can't join 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.