Lower Limb Amputation KneeNCT04217005
Enhancing Abilities in Amputees and Patients With Peripheral Neuropathy Through Restoration of Sensory Feedback
A study testing Sensory Feedback in people with Lower Limb Amputation Knee and Lower Limb Amputation Above Knee (Injury), run by ETH Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lower Limb Amputation Knee, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Sensory Feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Dec 2019to 15 Jan 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
ETH Zurich
Zurich, 8006
Greta Preatoni, PhD, 0766274077 ext. 0041, gretapreatoni1@gmail.com
Michele Marazzi, PhD, +41446322840 ext. 0041, michele.marazzi@hest.ethz.ch
About this study
Official title: 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
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.
- Conditions
- Lower Limb Amputation Knee, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Diabetic Peripheral Neuropathy
- Being tested
- Sensory Feedback
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory FeedbackDevice
Subjects will receive a sensory feedback provided by electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | amputees or diabetics receiving intervention Receives: Device: Sensory Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Visual Analogue scale for pain throughout the study
Subjects will complete VAS scale to measure pain level (from 0 to 10, 10 is worst pain immaginable)
Measured: 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
Change between tasks with sensory feedback and with no sensory feedback in Ground Reaction Forces
GRF will be assessed during motor perfomances of the subjects
Measured: during motor tasks up to 3 weeks
Change between tasks with sensory feedback and with no sensory feedback in Centre of Mass and Pressure
CoM and CoP will be assessed during motor perfomances of the subjects
Measured: during motor tasks up to 3 weeks
Change from baseline and between tasks with sensory feedback and with no sensory feedback in Vo2 consumption
metabolic consumption is going to be measured with mobile spiroergometry and compared after walking with and without sensory feedback
Measured: during motor tasks up to 3 weeks
Change from baseline between tasks with sensory feedback and with no sensory feedback in Embodiment
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))
Measured: immediately after sessions up to 3 weeks
Change between tasks with sensory feedback and with no sensory feedback in Visual Analogue scale for confidence
Subjects will complete VAS scale to measure confidence level (from 0 to 10, where 10 is max confidence)
Measured: immediately after sessions up to three weeks
Change between tasks with sensory feedback and with no sensory feedback in Joint torque
kinematic measurement
Measured: during motor tasks up to three weeks
Change in Proprioceptive drift between different conditions
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.
Measured: Immediately after sessions in Virtual Reality up to three weeks
Change in Telescoping measures between different conditions
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.
Measured: Immediately after sessions in Virtual Reality up to three weeks
Secondary outcomes (3)
Trinity Amputation and Prosthesis Experiences Scales
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)
Measured: Immediately before intervention
Change in Quality of Life in Neurological Disorders
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)
Measured: one week before first session and one week after last session
Amputee Mobility Predictor
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)
Measured: Immediately before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start13 Dec 2019
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Amputation KneeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETH Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greta Preatoni, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217005
- Sponsor's protocol ID
- 2019-N-97
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care. 2011 Oct;34(10):2220-4. doi: 10.2337/dc11-1108. Epub 2011 Aug 18.
PubMed 21852677Archer AG, Watkins PJ, Thomas PK, Sharma AK, Payan J. The natural history of acute painful neuropathy in diabetes mellitus. J Neurol Neurosurg Psychiatry. 1983 Jun;46(6):491-9. doi: 10.1136/jnnp.46.6.491.
PubMed 6875582Burke MJ, Roman V, Wright V. Bone and joint changes in lower limb amputees. Ann Rheum Dis. 1978 Jun;37(3):252-4. doi: 10.1136/ard.37.3.252.
PubMed 150823Antfolk C, D'Alonzo M, Rosen B, Lundborg G, Sebelius F, Cipriani C. Sensory feedback in upper limb prosthetics. Expert Rev Med Devices. 2013 Jan;10(1):45-54. doi: 10.1586/erd.12.68.
PubMed 23278223Oddo CM, Raspopovic S, Artoni F, Mazzoni A, Spigler G, Petrini F, Giambattistelli F, Vecchio F, Miraglia F, Zollo L, Di Pino G, Camboni D, Carrozza MC, Guglielmelli E, Rossini PM, Faraguna U, Micera S. Intraneural stimulation elicits discrimination of textural features by artificial fingertip in intact and amputee humans. Elife. 2016 Mar 8;5:e09148. doi: 10.7554/eLife.09148.
PubMed 26952132Charkhkar H, Shell CE, Marasco PD, Pinault GJ, Tyler DJ, Triolo RJ. High-density peripheral nerve cuffs restore natural sensation to individuals with lower-limb amputations. J Neural Eng. 2018 Oct;15(5):056002. doi: 10.1088/1741-2552/aac964. Epub 2018 Jun 1.
PubMed 29855427Chow DH, Cheng CT. Quantitative analysis of the effects of audio biofeedback on weight-bearing characteristics of persons with transtibial amputation during early prosthetic ambulation. J Rehabil Res Dev. 2000 May-Jun;37(3):255-60.
PubMed 10917257Tan DW, Schiefer MA, Keith MW, Anderson JR, Tyler J, Tyler DJ. A neural interface provides long-term stable natural touch perception. Sci Transl Med. 2014 Oct 8;6(257):257ra138. doi: 10.1126/scitranslmed.3008669.
PubMed 25298320Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
PubMed 23900134Dosen S, Markovic M, Strbac M, Belic M, Kojic V, Bijelic G, Keller T, Farina D. Multichannel Electrotactile Feedback With Spatial and Mixed Coding for Closed-Loop Control of Grasping Force in Hand Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar;25(3):183-195. doi: 10.1109/TNSRE.2016.2550864. Epub 2016 Apr 7.
PubMed 27071179Clippinger FW, Seaber AV, McElhaney JH, Harrelson JM, Maxwell GM. Afferent sensory feedback for lower extremity prosthesis. Clin Orthop Relat Res. 1982 Sep;(169):202-6.
PubMed 7105581Rognini G, Petrini FM, Raspopovic S, Valle G, Granata G, Strauss I, Solca M, Bello-Ruiz J, Herbelin B, Mange R, D'Anna E, Di Iorio R, Di Pino G, Andreu D, Guiraud D, Stieglitz T, Rossini PM, Serino A, Micera S, Blanke O. Multisensory bionic limb to achieve prosthesis embodiment and reduce distorted phantom limb perceptions. J Neurol Neurosurg Psychiatry. 2019 Jul;90(7):833-836. doi: 10.1136/jnnp-2018-318570. Epub 2018 Aug 12. No abstract available.
PubMed 30100550Sadeghi H, Allard P, Prince F, Labelle H. Symmetry and limb dominance in able-bodied gait: a review. Gait Posture. 2000 Sep;12(1):34-45. doi: 10.1016/s0966-6362(00)00070-9.
PubMed 10996295Naschitz JE, Lenger R. Why traumatic leg amputees are at increased risk for cardiovascular diseases. QJM. 2008 Apr;101(4):251-9. doi: 10.1093/qjmed/hcm131. Epub 2008 Feb 16.
PubMed 18281705Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care. 1997 Nov;20(11):1702-5. doi: 10.2337/diacare.20.11.1702.
PubMed 9353612
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04217005
- Acronym / sponsor ID
- 2019-N-97
- Conditions
- Lower Limb Amputation Knee, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ETH ZurichUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 3 Jan 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Sensory Feedbackamputees or diabetics receiving intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Sensory FeedbackSubjects will receive a sensory feedback provided by electrical stimulation | Device | experimental group |
Primary outcome
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.
3 secondary outcomes
Trinity Amputation and Prosthesis Experiences Scales
Time frame: Immediately before intervention
Change in Quality of Life in Neurological Disorders
Time frame: one week before first session and one week after last session
Amputee Mobility Predictor
Time frame: Immediately before the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 21852677Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care. 2011 Oct;34(10):2220-4. doi: 10.2337/dc11-1108. Epub 2011 Aug 18.
- Background: PubMed 6875582Archer AG, Watkins PJ, Thomas PK, Sharma AK, Payan J. The natural history of acute painful neuropathy in diabetes mellitus. J Neurol Neurosurg Psychiatry. 1983 Jun;46(6):491-9. doi: 10.1136/jnnp.46.6.491.
- Background: PubMed 150823Burke MJ, Roman V, Wright V. Bone and joint changes in lower limb amputees. Ann Rheum Dis. 1978 Jun;37(3):252-4. doi: 10.1136/ard.37.3.252.
- Background: PubMed 23278223Antfolk C, D'Alonzo M, Rosen B, Lundborg G, Sebelius F, Cipriani C. Sensory feedback in upper limb prosthetics. Expert Rev Med Devices. 2013 Jan;10(1):45-54. doi: 10.1586/erd.12.68.
- Background: PubMed 26952132Oddo CM, Raspopovic S, Artoni F, Mazzoni A, Spigler G, Petrini F, Giambattistelli F, Vecchio F, Miraglia F, Zollo L, Di Pino G, Camboni D, Carrozza MC, Guglielmelli E, Rossini PM, Faraguna U, Micera S. Intraneural stimulation elicits discrimination of textural features by artificial fingertip in intact and amputee humans. Elife. 2016 Mar 8;5:e09148. doi: 10.7554/eLife.09148.
- Background: PubMed 29855427Charkhkar H, Shell CE, Marasco PD, Pinault GJ, Tyler DJ, Triolo RJ. High-density peripheral nerve cuffs restore natural sensation to individuals with lower-limb amputations. J Neural Eng. 2018 Oct;15(5):056002. doi: 10.1088/1741-2552/aac964. Epub 2018 Jun 1.
- Background: PubMed 10917257Chow DH, Cheng CT. Quantitative analysis of the effects of audio biofeedback on weight-bearing characteristics of persons with transtibial amputation during early prosthetic ambulation. J Rehabil Res Dev. 2000 May-Jun;37(3):255-60.
- Background: PubMed 25298320Tan DW, Schiefer MA, Keith MW, Anderson JR, Tyler J, Tyler DJ. A neural interface provides long-term stable natural touch perception. Sci Transl Med. 2014 Oct 8;6(257):257ra138. doi: 10.1126/scitranslmed.3008669.
- Background: PubMed 23900134Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
- Background: PubMed 27071179Dosen S, Markovic M, Strbac M, Belic M, Kojic V, Bijelic G, Keller T, Farina D. Multichannel Electrotactile Feedback With Spatial and Mixed Coding for Closed-Loop Control of Grasping Force in Hand Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar;25(3):183-195. doi: 10.1109/TNSRE.2016.2550864. Epub 2016 Apr 7.
- Background: PubMed 7105581Clippinger FW, Seaber AV, McElhaney JH, Harrelson JM, Maxwell GM. Afferent sensory feedback for lower extremity prosthesis. Clin Orthop Relat Res. 1982 Sep;(169):202-6.
- Background: PubMed 30100550Rognini G, Petrini FM, Raspopovic S, Valle G, Granata G, Strauss I, Solca M, Bello-Ruiz J, Herbelin B, Mange R, D'Anna E, Di Iorio R, Di Pino G, Andreu D, Guiraud D, Stieglitz T, Rossini PM, Serino A, Micera S, Blanke O. Multisensory bionic limb to achieve prosthesis embodiment and reduce distorted phantom limb perceptions. J Neurol Neurosurg Psychiatry. 2019 Jul;90(7):833-836. doi: 10.1136/jnnp-2018-318570. Epub 2018 Aug 12. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Feedback in people with Lower Limb Amputation Knee and Lower Limb Amputation Above Knee (Injury), run by ETH Zurich at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact greta preatoni, PhD (766274077 ext. 0041, gretapreatoni1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217005, which also lists 23 linked publications.
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 20 Feb 2024.