Transcutaneous Electrical Stimulation in Lower Limb Amputees

NCT06160336 | Completed

• 1 other identifier: SENSE
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Amputation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Changes in body weight distribution between legs during gait

  Baseline; after a 1-month intervention

• Changes in gait symmetry

  Baseline; after a 1-month intervention

• Changes in Pain Intensity (NRS)

  Baseline; after a 1-month intervention

• Changes in Neuropathic Pain (NPSI)

  Baseline; after a 1-month intervention

Study Arms (1)

TENS group

EXPERIMENTAL

Other: Transcutaneous Electrical Nerve Stimulation

Interventions

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: 1. four mapping sessions conducted at the onset of each week, where the protocol is randomly applied to the participant's intact and amputated limb. 2. three stimulation sessions held over three consecutive days in the initial week to assess the participant's ability to discern stimuli of varying intensities. 3. ten sessions utilizing an end-effector gait rehabilitation robot, aiming to train the participant in walking using the proposed sensory feedback restoration system based on TENS under controlled and repeatable experimental conditions.

TENS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 80 years;
• unilateral transtibial amputation or transfemoral amputation at least two months prior the study;
• stable clinical conditions;
• skin integrity;
• absence of cognitive deficits.

You may not qualify 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Campus Bio-Medico University: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, Italy

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: March 14, 2021
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

IT (1)