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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Transcutaneal Electrical Nerve Stimulation
Other interventionEach patient will undergo two 60-minute sessions per day, except for the evaluation ones which are expected to last approximately 90 minutes, five days per week for a total duration of 4 weeks. 1. Mapping sessions: Four Mapping sessions performed at the beginning of each week. 2. Stimulus Intensity Discrimination sessions: Three Stimulus Intensity Discrimination sessions will be conducted over three consecutive days during the first week. 3. Rehabilitative sessions: Ten rehabilitative sessions aimed at re-educating walking in controlled and repeatable experimental conditions while simultaneously using the device with either technological solutions or proprioceptive exercises will be carried out. 4. Evaluation sessions: Three evaluation sessions will be performed at the beginning (T0), in the middle (T1) and at the end (T2) of the experimental protocol.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: TENS GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ad hoc developed psychometric questionnaires
The primary endpoint of the study will be the change in the phantom limb perception and a modification of post-amputation neuropathic pain between the beginning (T0 at Day 0) and immediately after the intervention (T2 at Day 20). For each delivered stimulus, the patient will be asked to indicate the location of the evoked sensation adopting pictures representing the missing foot and leg and then to describe them. The descriptors included: a five-point scale for the naturalness ranging from unnatural to natural, a metric of the location of the sensation (i.e., superficial and/or deep), a scale from 0 to 10 for the intensity and pain of the sensation and multiple choices for the quality (touch/pression, pinch, vibration, tugging, tingling, burning, hot, cold, ankle flexion, ankle extension, toes flexion, toes extension and nothing).
Time frame
At baseline (Day 0) and immediately after the intervention (Day 20)Secondary outcomes
1
Changes in ambulation performances
The parameters adopted to quantify the patients' ambulation performance will be the stance/swing phase and gait cycle duration for both limbs.
Time frame
At baseline (Day 0) and immediately after the intervention (Day 20)2
Changes in ambulation performances
The parameters adopted to quantify the patients' ambulation performance will be the vertical Ground Reaction Force (vGRF) exerted on the ground by both limbs and the related peak values
Time frame
At baseline (Day 0) and immediately after the intervention (Day 20)]3
Changes in ambulation performances
The parameters adopted to quantify the patients' ambulation performance will be the trunk, hip, knee and ankle flexion/extension of both limbs.
Time frame
At baseline (Day 0) and immediately after the intervention (Day 20)]4
Changes in ambulation performance
The parameters adopted to quantify the patients' ambulation performance will be the walking speed.
Time frame
At baseline (Day 0) and immediately after the intervention (Day 20)]Sponsors and contacts
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Campus Bio-Medico University
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborator
Source ClinicalTrials.gov