Restoring Somatotopic Sensory Feedback in Lower Limb Amputees through Noninvasive Nerve Stimulation.
Andrea Demofonti, Marco Germanotta, Andrea Zingaro...
https://pubmed.ncbi.nlm.nih.gov/40302942Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07448350
Transcutaneous Electrical Nerve Stimulation for Restoring Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Led by Campus Bio-Medico University · Updated on 2026-05-13
15
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Campus Bio-Medico University
Lead Sponsor
F
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on people with lower limb amputations. The study aims to assess how TENS treatment changes the perception of phantom limb pain and affects posture, balance, and walking ability. The trial involves adults with unilateral transtibial or transfemoral amputations who meet specific health and mobility criteria. Participants will undergo 20 sessions over 4 weeks, including mapping sessions to identify nerve stimulation points, stimulus intensity discrimination sessions to train perception of different electrical stimuli, rehabilitative sessions combining TENS with walking exercises or proprioceptive training, and evaluation sessions to measure progress. Each session lasts about 60 minutes, except evaluations which last about 90 minutes. The treatment uses a custom electrical stimulation device synchronized with walking tasks and sometimes a robotic treadmill with virtual reality. Throughout the study, participants will be regularly assessed using psychometric questionnaires and detailed gait analysis with motion tracking cameras and force platforms. Evaluations occur at the start, middle, and end of the 4-week period. Researchers will monitor changes in phantom limb perception, walking performance on various surfaces, and neuropathic pain levels. The study ends with the final evaluation or earlier if the participant withdraws or passes away.
CONDITIONS
Brief Title
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Unilateral transtibial or transfemoral amputation at least two months before the study
- Stable clinical health conditions
- Intact skin over the residual limb
- No cognitive deficits
- Able to walk using a prosthesis
- No previous experience with TENS treatment
You will not qualify if you...
- Bilateral amputation
- Open wounds or sores on the residual limb
- Cognitive deficits
- Pregnancy
- Presence of implanted medical devices such as pacemakers or defibrillators
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Mapping Sessions
Duration - 4 weeks
Participants attend four mapping sessions at the beginning of each week to identify and tune sensory stimulation parameters and characterize sensations on both limbs.
4 visits (in-person, one at the start of each week)
Stimulus Intensity Discrimination
Duration - 3 days
Participants complete three sessions over three consecutive days in the first week to evaluate their ability to differentiate between stimuli of varying intensity.
3 visits (in-person, consecutive days)
Rehabilitative Sessions
Duration - 4 weeks
Participants undergo ten rehabilitative sessions aimed at retraining walking under controlled conditions while using electrical stimulation combined with technological solutions or proprioceptive exercises.
10 visits (in-person, spread over 4 weeks)
Evaluation Sessions
Duration - 4 weeks
Participants take part in three evaluation sessions at the beginning, middle, and end of the protocol to assess phantom limb perception, gait biomechanics, and clinical neuropathic pain surveys.
3 visits (in-person, at start, mid, and end of the study)
Trial Site Locations
Total: 1 location
1
Don Gnocchi Foundation
Rome, Rome, Italy, 00168
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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