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Enhancing Abilities in Amputees and Patients With Peripheral Neuropathy Through Restoration of Sensory Feedback

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ClinicalTrials.gov Identifier: NCT04217005
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Greta Preatoni, ETH Zurich

Tracking Information
First Submitted Date  ICMJE December 10, 2019
First Posted Date  ICMJE January 3, 2020
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE December 13, 2019
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2019)
  • Change from baseline in Visual Analogue scale for pain throughout the study [ Time Frame: one month before the study, 2 weeks before the study, immediately before the intervention, immediately after the intervento, after tasks with and without sensory feedback, 2 weeks after last intervention, 1 month after last intervention ]
    Subjects will complete VAS scale to measure pain level (from 0 to 10, 10 is worst pain immaginable)
  • Change between tasks with sensory feedback and with no sensory feedback in Ground Reaction Forces [ Time Frame: during motor tasks up to 3 weeks ]
    GRF will be assessed during motor perfomances of the subjects
  • Change between tasks with sensory feedback and with no sensory feedback in Centre of Mass and Pressure [ Time Frame: during motor tasks up to 3 weeks ]
    CoM and CoP will be assessed during motor perfomances of the subjects
  • Change from baseline and between tasks with sensory feedback and with no sensory feedback in Vo2 consumption [ Time Frame: during motor tasks up to 3 weeks ]
    metabolic consumption is going to be measured with mobile spiroergometry and compared after walking with and without sensory feedback
  • Change from baseline between tasks with sensory feedback and with no sensory feedback in Embodiment [ Time Frame: immediately after sessions up to 3 weeks ]
    Embodiment will be measured with questionnaires (from -3 to +3, +3 totally agrees; two questions are from 1 to 10 (to measure vividness, where 10 is max vividness) and from 1 to 100 (to measure prevalence, where 100 is max duration of the embodiment feeling))
  • Change between tasks with sensory feedback and with no sensory feedback in Visual Analogue scale for confidence [ Time Frame: immediately after sessions up to three weeks ]
    Subjects will complete VAS scale to measure confidence level (from 0 to 10, where 10 is max confidence)
  • Change between tasks with sensory feedback and with no sensory feedback in Joint torque [ Time Frame: during motor tasks up to three weeks ]
    kinematic measurement
  • Change in Proprioceptive drift between different conditions [ Time Frame: Immediately after sessions in Virtual Reality up to three weeks ]
    To measure embodiment subjects will be asked after VR sessions to indicate where they feel their leg without looking at the limb in real world. This is a measure of embodiment.
  • Change in Telescoping measures between different conditions [ Time Frame: Immediately after sessions in Virtual Reality up to three weeks ]
    To measure embodiment subjects will be asked after VR sessions to indicate how long they feel their leg without looking at the limb in real world. This is a measure of embodiment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2019)
  • Trinity Amputation and Prosthesis Experiences Scales [ Time Frame: Immediately before intervention ]
    Subjects will fill the TAPES to measure their satisfaction with the prosthesis (Scores range from 5 to 25, with higher scores indicating greater levels of adjustment)
  • Change in Quality of Life in Neurological Disorders [ Time Frame: one week before first session and one week after last session ]
    QoL will be assessed through questionnaires to see if the intevention had impact on this aspect (All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured)
  • Amputee Mobility Predictor [ Time Frame: Immediately before the intervention ]
    Subjects will perform AMPRO to assess K level (scores range from 0 to 47, correspoding to levels of mobility from 1(K1) to 4(K4), where 4 is the best level of mobility)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Abilities in Amputees and Patients With Peripheral Neuropathy Through Restoration of Sensory Feedback
Official Title  ICMJE 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
Brief Summary

Many amputees suffer from Phantom Limb Pain (PLP), a condition where painful perceptions arise from the missing limb. Leg amputees wear prostheses that do not provide any sensory feedback, apart from the stump-socket interaction. Increased physical effort associated with prosthesis use as well as discomfort often lead to rejection of artificial limbs. Additionally, the perception of the missing limb and its brain representation, do not match-up with what amputees see (the prosthesis) and this is made worse by the absence of sensory feedback. Therefore, re-establishing the sensory flow of information between the subject's brain and the prosthetic device is extremely important to avoid this mismatch, which creates inadequate embodiment. This study focuses on improving functional abilities and decreasing PLP in amputees thanks to the use of a system able to generate a sensory feedback (SF), which will be provided with a non-invasive electrical stimulation (ES). First, the possibility of enhancing the performance in different functional tasks thanks to the use of SF will be explored. Furthermore, it will be evaluated if SF enhances the prosthesis embodiment and helps restoring a multisensory integration (visuo-tactile), potentially providing also a pain relief. Once tested this system on amputees, also people with peripheral neuropathy and sensory loss will be recruited. Diabetic patients can suffer from symmetrical polyneuropathy (DSPN), which is a common complication caused by prolonged glucose unbalanced levels that lead to nerve damage. Non-invasive ES has been proposed and used as a therapy to treat the chronic pain conditions. In particular, TENS (transcutaneous electrical nerve stimulation) is a type of non-invasive ES, which is able to activate large diameter afferent fibers. The gate control theory of pain states that these large diameter fibers inhibit central nociceptive transmission with a resultant decrease in pain perception. Therefore, also these patients will be recruited to see whether adding a non-invasive SF can enhance their functional motor abilities while diminishing their pain.

The subjects will perform a pool of the following tasks, depending on their residual abilities: motor tasks (walking on ground level and on stairs), cognitive tasks (dual tasks), subjective evaluation of prosthesis weight and description of sensations from ES.

Some tasks will be performed in Virtual Reality environments with and without an active stimulation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Lower Limb Amputation Knee
  • Lower Limb Amputation Above Knee (Injury)
  • Lower Limb Amputation Below Knee (Injury)
  • Diabetic Peripheral Neuropathy
Intervention  ICMJE Device: Sensory Feedback
Subjects will receive a sensory feedback provided by electrical stimulation
Study Arms  ICMJE Experimental: experimental group
amputees or diabetics receiving intervention
Intervention: Device: Sensory Feedback
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 31, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2021
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: greta preatoni, PhD 766274077 ext 0041 gretapreatoni1@gmail.com
Contact: michele marazzi, PhD 446322840 ext 0041 michele.marazzi@hest.ethz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04217005
Other Study ID Numbers  ICMJE 2019-N-97
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Greta Preatoni, ETH Zurich
Study Sponsor  ICMJE ETH Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ETH Zurich
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP