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| Name | Class |
|---|---|
| Campus Bio-Medico University | OTHER |
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Current lower limb prostheses support ambulation by absorbing and stabilizing positions during walking. Users of lower limb prostheses rely solely on sensory information provided by the contact between the socket and the residual limb. Restoring sensory feedback could potentially improve their quality of life and participation in daily activities. Despite a high incidence of lower limb amputations, there are few studies in the literature addressing the restoration of sensory feedback in lower limb amputees, particularly studies utilizing invasive techniques. In an effort to overcome these limitations, various non-invasive methods have been tested. Despite resulting benefits such as improved gait symmetry and stability, most non-invasive stimulation systems are non-somatotopic, failing to generate a sensation referred to the patient's missing limb. From the literature, Transcutaneous Electrical Nerve Stimulation (TENS) emerges as a very promising non-invasive and somatotopically-based sensory feedback approach, capable of inducing sensations referred to the amputees' phantom limb.
Therefore, the proposed study will involve the use of TENS as a means to stimulate sensitivity and prevent perceptual disturbances associated with the interruption of peripheral nerve structures occurring in individuals undergoing amputation. These disturbances, besides influencing the development of symptoms characterized by neuropathic pain, can impact prosthesis management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Other | Phase 1: Participants undergo a comprehensive assessment in a single experimental session (mapping session) aimed at mapping the regions and sensations that can be electrically stimulated. This mapping protocol is conducted on both the intact and amputated limbs. Phase 2: This phase comprises a 4-week experimental protocol, including:
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| Measure | Description | Time Frame |
|---|---|---|
| Electrical Sensation Mapping Questionnaire | It is an ad-hoc questionnaire designed for comprehensive characterization of sensations elicited through TENS. This includes perceptual thresholds, referred sensations (evaluated for naturalness, depth, pain, intensity, and quality), sensitivity, size, and similarity of the activated areas. The questionnaire incorporates: a five-point scale assessing naturalness from unnatural to natural, a metric to determine the sensation's location (i.e., superficial and/or deep), a scale from 0 to 10 measuring the intensity and pain levels of the sensation, and multiple choice options to describe the quality (touch/pressure, pinch, vibration, tugging, tingling, burning, hot, cold, ankle flexion, ankle extension, toe flexion, toe extension, and none) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight distribution between legs during gait | Assessment of the force exerted on the ground during walking using an ad-hoc developed insole equipped with sensors, designed to be inserted under the participant's prosthetic foot. | Baseline; after a 1-month intervention |
| Changes in gait symmetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza | Roma | Italy |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Evaluation of the symmetry between the intact and the amputated limbs based on spatio-temporal gait parameter, measured using an optoelectronic system |
| Baseline; after a 1-month intervention |
| Changes in Pain Intensity (NRS) | The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable) | Baseline; after a 1-month intervention |
| Changes in Neuropathic Pain (NPSI) | The NPSI is one of the most extensively used instruments for assessing the intensity of neuropathic pain symptoms. It consists of 10 items corresponding to sensory descriptors that can be grouped into 5 dimensions: spontaneous burning pain (burning), spontaneous pressing pain (pressing), paroxysmal pain (paroxysmal), evoked pain (evoked), and paresthesia/dysesthesia. Each dimension can be scored between 0 and 10. In addition, a final score, equivalent to the total of the 10 descriptors and ranging from 0 (best) to 100 (worst), can be calculated. | Baseline; after a 1-month intervention |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |