Improving sensory feedback for amputees and patients with diabetic neuropathy
Enhancing Functional and Cognitive Performances in People With Amputation and Peripheral Neuropathy Through the Restoration of Sensory Feedback in Real World and Virtual Reality Environments
This study is testing a new way to help amputees and people with diabetic nerve damage feel better and walk easier by using electrical stimulation to restore sensory feedback from their prosthetic devices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | ETH Zurich Academic / other |
| Locations | 1 site (Zürich) |
| Trial ID | NCT04217005 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the functional abilities of amputees and individuals with diabetic peripheral neuropathy by restoring sensory feedback through non-invasive electrical stimulation. Many amputees experience phantom limb pain and discomfort due to the lack of sensory input from their prosthetic devices, leading to rejection of these limbs. By using a system that generates sensory feedback, the study seeks to improve the embodiment of the prosthesis and reduce pain perceptions. Participants will be monitored for improvements in their ability to walk and overall comfort with their prosthetic devices.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-70 with transfemoral or transtibial amputations or diabetic peripheral neuropathy who are otherwise healthy.
Not a fit: Patients with cognitive impairments, psychological disorders, or those who experience excessive sensitivity to electrical stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce phantom limb pain and improve the quality of life for amputees and patients with diabetic neuropathy.
How similar studies have performed: While the approach of restoring sensory feedback is innovative, similar studies have shown promise in improving outcomes for amputees, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * transfemoral amputation or transtibial amputation or knee disarticulation or diabetic peripheral neuropathy * the subject should be healthy other than the amputation and the diabetic neuropathy and in the range of 18-70 years old * the subject should be able to comfortably walk, sit and stand alone Exclusion Criteria: * cognitive impairment * pregnancy * Prior or current psychological diseases such as borderline, schizophrenia, Depression or Maniac Depression * acquired brain injury with residual impairment * excessive sensitivity or pain to electrical stimulation with surface electrodes * cybersickness
Where this trial is running
Zürich
- ETH Zurich — Zürich, Switzerland (Recruiting)
Study contacts
- Study coordinator: greta preatoni, PhD
- Email: gretapreatoni1@gmail.com
- Phone: 766274077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.