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Prosthesis With Sensations

NCT03350061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-07-15

No results posted yet for this study

Summary

Lower limb amputees suffer complete lack of sensory feedback of current available prostheses, which excludes the central nervous system from the correct sensory-motor integration. It causes serious problems as: falls due to unexpected perturbations, asymmetric walking, low mobility, higher power consumption, feeling the prosthesis as a foreign body, high cognitive burden, and phantom limb pain occurrence.

Investigators will provide amputees with a prosthesis restoring sensory feedback and will assess its benefits on the users.

Conditions

  • Amputation
  • Phantom Limb Pain
  • Sensory Deficit

Interventions

DEVICE

SENSY

The sensory feedback will be delivered by SENSY with or without the leg prosthesis. Benefits connected to the stimulation of sensory nerves will be assessed.

Sponsors & Collaborators

  • Axonic

    collaborator UNKNOWN

  • SensArs Neuroprosthetics Sarl

    collaborator INDUSTRY

  • Institut für Mikrosystemtechnik (IMTEK), Albert-Ludwigs-Universität Freiburg

    collaborator UNKNOWN

  • Ripple LLC

    collaborator UNKNOWN

  • Össur hf

    collaborator UNKNOWN

  • Clinical Centre of Serbia

    lead OTHER

Principal Investigators

  • Aleksandar Lešić, Prof · Clinical center of Serbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-12
Primary Completion
2018-08-01
Completion
2020-07-14

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350061 on ClinicalTrials.gov