Lower Limb AmputationNCT06160336
Transcutaneous Electrical Stimulation in Lower Limb Amputees
A study testing Transcutaneous Electrical Nerve Stimulation in people with Lower Limb Amputation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2021to 4 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Roma
About this study
Official title: Use of Transcutaneous Electrical Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees
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
- Being tested
- Transcutaneous Electrical Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationOther
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:
- four mapping sessions conducted at the onset of each week, where the protocol is randomly applied to the participant's intact and amputated limb.
- three stimulation sessions held over three consecutive days in the initial week to assess the participant's ability to discern stimuli of varying intensities.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TENS group | Experimental | Not described Receives: Other: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (4)
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.
Measured: Baseline; after a 1-month intervention
Changes in gait symmetry
Evaluation of the symmetry between the intact and the amputated limbs based on spatio-temporal gait parameter, measured using an optoelectronic system
Measured: 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)
Measured: 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.
Measured: Baseline; after a 1-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start14 Mar 2021
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160336
- Sponsor's protocol ID
- SENSE
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transcutaneous Electrical Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees
- ClinicalTrials.gov ID
- NCT06160336
- Acronym / sponsor ID
- SENSE
- Conditions
- Lower Limb Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Other: Transcutaneous Electrical Nerve Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationPhase 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. | Other | TENS group |
Primary outcome
Electrical Sensation Mapping Questionnaire
Time frame: Baseline
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)
4 secondary outcomes
Changes in body weight distribution between legs during gait
Time frame: Baseline; after a 1-month intervention
Changes in gait symmetry
Time frame: Baseline; after a 1-month intervention
Changes in Pain Intensity (NRS)
Time frame: Baseline; after a 1-month intervention
Changes in Neuropathic Pain (NPSI)
Time frame: Baseline; after a 1-month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Lower Limb Amputation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical Sensation Mapping Questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.