ProstheticNCT02189031
Sensory Feedback for Touch and Proprioception With Prosthetic Limbs
An observational study of Prosthetic, run by Louis Stokes VA Medical Center at 4 sites in 2 countries.
Trial summary
Upper limb amputation is a devastating injury that leaves many thousands of typically young and active individuals in the US to rely on artificial arms and hands to help restore their lost function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthetic
- What is being tested?
- Tactor array and Bypass Tactor
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2013to 17 Nov 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Amputees who have undergone targeted sensory reinnervation
Who may be able to join
- Amputee criteria:
- Must be over 18 years of age
- Must be upper extremity amputee who has undergone targeted sensory reinnervation.
- Able Bodied participants:
- Must be over 18 years of age
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Rehabilitation Institute of Chicago
Chicago, Ill, 60611
Louis Stokes VA Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Lerner Research Institute
Cleveland, Ohio, 44195
Canada1 site
University of Alberta Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5B0B7
About this study
Official title: Sensory Feedback Tactor Systems for Implementation of Physiologically Relevant Cutaneous Touch and Proprioception With Prosthetic Limbs
Upper limb amputation is a devastating injury that leaves many thousands of typically young and active individuals in the US to rely on artificial arms and hands to help restore their lost function. The investigators research is focused on helping these individuals to feel where their prosthetic limbs are moving without having to look at them by developing devices and approaches to provide sensory feedback of limb movement through the nerves that once served the missing limb.
Read the detailed description
In the investigators research the investigators seek to understand the organization and (function/operation) of sensory neural systems in order to develop methods for restoring function to injured populations. One of the primary focus areas of the investigators research is working to integrate physiologically relevant sensory feedback with prosthetic limbs. To this end the investigators employ a variety of approaches that interweave disciplines such as electrophysiology, psychophysics, biomedical engineering and cognition. The investigators research team is composed of an interconnected and communicative network of clinicians, engineers, and scientists. This helps us to provide pathways from basic science discoveries that can be used to address clinical needs with transition directly to patient care.
- Conditions
- Prosthetic
- Being tested
- Tactor array, Bypass Tactor
- Keywords
- Upper limb Amputee, Targeted Muscle Reinnervation, Prosthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactor arrayDevice
Bypass TactorDevice
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Amputee | Robust custom tactor to facilitate embodiment and proprioception Receives: Device: Tactor array | |
| Able Bodied | Bypass tactor Receives: Device: Bypass Tactor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embodiment of the Prosthetic limb
Visual loading for fine motor tasks,questionnaires, and residual limb temperature will be assessed after 10 months of in home every day use of a custom robust tactor array for sensory feedback.
Measured: Ten months
Secondary outcomes (1)
Investigate the perceptions of limb movement
Test how closely both targeted reinnervation amputees and able bodied study participants are able to interpret limb movement using the kinesthetic perceptual illusion and physiologically relevant kinesthetic feedback.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startFeb 2013
- Primary completion17 Oct 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstheticStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), The Cleveland Clinic, HDT Global, University of Alberta, Shirley Ryan AbilityLab, Defense Advanced Research Projects Agency
- Responsible party
- Principal investigator, Paul Marasco, Louis Stokes VA Medical Center
- Investigators
- Paul Marasco, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189031
- Sponsor's protocol ID
- 11061-H39
- Other IDs
- R01NS081710-01
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2014
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Feedback Tactor Systems for Implementation of Physiologically Relevant Cutaneous Touch and Proprioception With Prosthetic Limbs
- ClinicalTrials.gov ID
- NCT02189031
- Acronym / sponsor ID
- 11061-H39
- Conditions
- Prosthetic
- Keywords
- Upper limb Amputee, Targeted Muscle Reinnervation, Prosthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), The Cleveland Clinic, HDT Global, University of Alberta, Shirley Ryan AbilityLab, Defense Advanced Research Projects Agency
- Study start
- Feb 2013
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 14 Jul 2014 (estimated)
- 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.
Upper limb amputation is a devastating injury that leaves many thousands of typically young and active individuals in the US to rely on artificial arms and hands to help restore their lost function. The investigators research is focused on helping these individuals to feel where their prosthetic limbs are moving without having to look at them by developing devices and approaches to provide sensory feedback of limb movement through the nerves that once served the missing limb.
Detailed description
In the investigators research the investigators seek to understand the organization and (function/operation) of sensory neural systems in order to develop methods for restoring function to injured populations. One of the primary focus areas of the investigators research is working to integrate physiologically relevant sensory feedback with prosthetic limbs. To this end the investigators employ a variety of approaches that interweave disciplines such as electrophysiology, psychophysics, biomedical engineering and cognition. The investigators research team is composed of an interconnected and communicative network of clinicians, engineers, and scientists. This helps us to provide pathways from basic science discoveries that can be used to address clinical needs with transition directly to patient care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Amputee | – | Device: Tactor arrayRobust custom tactor to facilitate embodiment and proprioception |
| Able Bodied | – | Device: Bypass TactorBypass tactor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Amputees who have undergone targeted sensory reinnervation
Key inclusion criteria (5 listed)
- Must be over 18 years of age
- Must be upper extremity amputee who has undergone targeted sensory reinnervation.
- Must be over 18 years of age
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tactor array | Device | Upper Extremity Amputee |
| Bypass Tactor | Device | Able Bodied |
Primary outcome
Embodiment of the Prosthetic limb
Time frame: Ten months
Visual loading for fine motor tasks,questionnaires, and residual limb temperature will be assessed after 10 months of in home every day use of a custom robust tactor array for sensory feedback.
1 secondary outcome
Investigate the perceptions of limb movement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Related InfoLink provided by the sponsor.
Related trials for Prosthetic
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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
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Influence of Prosthetic Characteristics of Implant-Supported Crowns on Peri-implant Health and Osseointegration: A Comparison Between Digital and Conventional Workflows.
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Recruiting
How to Prevent Post-surgery Infections
ASA III, Elective Prosthetic Surgery
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
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.
Paul Marasco, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic, run by Louis Stokes VA Medical Center at 4 sites in 2 countries.
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 5 inclusion and 0 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embodiment of the Prosthetic limb (time frame: Ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.