Using TENS to restore localized limb sensations and improve phantom limb perception after above- or below-knee amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with unilateral transtibial or transfemoral amputation receive a four-week, clinic-based program combining TENS and conventional rehabilitation delivered five days per week. Sessions include repeated sensory mapping to locate optimal electrode positions over the tibial or sciatic nerve, stimulus intensity discrimination training, and rehabilitation treatments, with evaluation sessions spaced through the course. Most sessions last about 60 minutes and evaluation sessions about 90 minutes, and all enrolled participants receive the same intervention (no randomization). The aim is to track changes in phantom limb perception, posture, balance, and gait following the TENS-enhanced rehabilitation program.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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's running

• Don Gnocchi Foundation
  Rome, Rome, Italy Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Suralis vibrotactile system for phantom limb pain after lower-limb amputation

  This pilot will test whether wearing the Suralis vibration feedback system during walking reduces phantom limb pain in people with a unilateral lower-limb amputation.

  Recruiting Median · Wiesbaden, Hesse · NCT07324109

• Taleo Adjust prosthetic foot with adjustable heel height

  This trial will test whether the Taleo Adjust prosthetic foot with a hydraulic ankle helps adults with above- or below-knee amputations wear different shoes or go barefoot and improve appearance and participation.

  Recruiting at 5 sites Otto Bock France SNC · Concarneau and 4 other locations · NCT07214493

• Access Socket: a flexible prosthetic socket for transtibial amputation

  This trial tests whether the Access Socket, a hybrid flexible socket, improves comfort and function for adults with transtibial amputations compared with standard rigid sockets.

  Recruiting at 5 sites Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Clamart and 4 other locations · NCT07592325

• Amputation stump microenvironment in people having a non-traumatic above-knee amputation

  This project will test whether microdialysis and tissue sampling can map the local biological environment in people having non-traumatic above-knee amputations.

  Recruiting University of Aarhus · Aarhus N · NCT07384689

• Microprocessor-controlled prosthetic knees for limited community ambulators with above-knee amputation.

  This test will see if switching to a microprocessor-controlled prosthetic knee reduces fall-related health problems and improves walking speed, mobility, and quality of life for adults with above-knee amputations who are limited community ambulators compared with non-microprocessor knees.

  Recruiting Hanger Institute for Clinical Research and Education, LLC · Austin, Texas · NCT06937242

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.