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NCT06160336
Transcutaneous Electrical Stimulation in Lower Limb Amputees
NA trial testing Transcutaneous Electrical Nerve Stimulation in Lower Limb Amputation in 13 participants. Completed in 4 August 2023.
4 August 2023
Quick facts
| Lead sponsor | Fondazione Don Carlo Gnocchi Onlus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 13 |
| Start date | 14 March 2021 |
| Primary completion | 4 August 2023 |
| Estimated completion | 4 August 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Transcutaneous Electrical Nerve Stimulation
Conditions studied
- Lower Limb Amputation — all drugs for Lower Limb Amputation →
Sponsor
Fondazione Don Carlo Gnocchi Onlus — full company profile →
Who can join
Adults 18 to 80, any sex, with Lower Limb Amputation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06160336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Transcutaneous Electrical Nerve Stimulation
Trials testing the same drug.
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- NCT06432686 — Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS · NA · not yet recruiting
Other recruiting trials for Lower Limb Amputation
Currently open trials in the same condition.
- NCT07191795 — Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback · NA · recruiting
- NCT06556082 — Effect of PNF-Based Upper Extremity Strengthening With Core Stabilization on Fitness in Amputee Football Players · NA · active not recruiting
- NCT05830630 — Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery · NA · recruiting
Other Fondazione Don Carlo Gnocchi Onlus trials
Trials by the same sponsor.
- NCT07252856 — Transcultural Digital Solutions in Phase III Cardiac Rehabilitation · NA · not yet recruiting
- NCT07290218 — Tridimensional Robotic Assessment of Neglect in Brain Injured Patients · not yet recruiting
- NCT07064226 — Validation of a Digital Intervention to Rehabilitate Cognitive Resources · NA · recruiting
- NCT07130929 — Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study. · NA · recruiting
- NCT07159854 — Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06160336 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Don Carlo Gnocchi Onlus
- Last refreshed: 13 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06160336.
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