Transcutaneous Electrical Stimulation in Lower Limb Amputees

NCT ID: NCT06160336

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-14
• Study Completion Date: 2023-08-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TENS group

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: 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.

Interventions

Transcutaneous Electrical Nerve Stimulation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. age between 18 and 80 years;

2. unilateral transtibial amputation or transfemoral amputation at least two months prior the study;

3. stable clinical conditions;

4. skin integrity;

5. absence of cognitive deficits.

Exclusion Criteria

1. bilateral amputation;

2. open wounds or sores on the residual limb;

3. cognitive deficits;

4. pregnancy;

5. presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps);

6. refusal to sign the informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, , Italy

Countries

Italy

Other Identifiers

SENSE

Identifier Type: -

Identifier Source: org_study_id