Prosthesis UserNCT03135847
Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees
A study testing Tactor in people with Prosthesis User and Amputation, run by The Cleveland Clinic.
Trial summary
To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User, Amputation
- What is being tested?
- Tactor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria are adults (18 years or over) with major limb amputation (at or above wrist or ankle).
- -
Who cannot join
- Exclusion criteria are any skin or pain conditions that would preclude ability to withstand pressures on their limb or to wear a prosthetic socket, or cognitive barriers precluding providing informed consent.
- -
About this study
Official title: Physiologically Relevant Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees
To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.
- Conditions
- Prosthesis User, Amputation
- Being tested
- Tactor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TactorDevice
The tactor is a small robot providing touch and vibration.
| Study group | Role | What they receive |
|---|---|---|
| Amputee and Able Bodied Subjects | Experimental | Map the locations in the skin or deeper muscle where limb movement perceptions occur. Use tactors (small robots providing touch and vibration) to mechanically provide sensation to the residual muscles in amputees and the intact muscles in able-bodied. The functional experiments will occur concurrently with development and application of new prosthetic socket designs to incorporate control and feedback. Receives: Device: Tactor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin or tendon location
Locations in the skin or muscle of the residual where percepts of touch or movement occur.
Measured: 36 months
Secondary outcomes (2)
Sorting Task
Performance on a sorting task with and without tactor feedback.
Measured: 36 months
Sense of Agency Questionnaire
Agreement with statements of agency and ownership related to perceptions of limb movement including unstructured self-reports.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Jun 2016
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Louis Stokes VA Medical Center, University of Alberta, HDT Robotics, United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Paul Marasco, The Cleveland Clinic
- Investigators
- Paul Marasco, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135847
- Sponsor's protocol ID
- 16-140
- Other IDs
- W81XWH-15-1-0575
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2017
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Significant scientific results and data will be shared. Final data sets will include information such as survey results, de-identified aggregate data of prosthetic users' abilities and functional outcomes, de-identified photographic/video. Non-proprietary/non-identifying data and findings will be disseminated in a timely manner through scientific seminars, meetings, and peer reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologically Relevant Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees
- ClinicalTrials.gov ID
- NCT03135847
- Acronym / sponsor ID
- 16-140
- Conditions
- Prosthesis User, Amputation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Louis Stokes VA Medical Center, University of Alberta, HDT Robotics, United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 1 May 2017 (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.
To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amputee and Able Bodied Subjects | Experimental | Device: TactorMap the locations in the skin or deeper muscle where limb movement perceptions occur. Use tactors (small robots providing touch and vibration) to mechanically provide sensation to the residual muscles in amputees and the intact muscles in able-bodied. The functional experiments will occur concurrently with development and application of new prosthetic socket designs to incorporate control and feedback. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusion criteria are adults (18 years or over) with major limb amputation (at or above wrist or ankle).
- -
Key exclusion criteria (2 listed)
- Exclusion criteria are any skin or pain conditions that would preclude ability to withstand pressures on their limb or to wear a prosthetic socket, or cognitive barriers precluding providing informed consent.
- -
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 |
|---|---|---|
| TactorThe tactor is a small robot providing touch and vibration. | Device | Amputee and Able Bodied Subjects |
Primary outcome
Skin or tendon location
Time frame: 36 months
Locations in the skin or muscle of the residual where percepts of touch or movement occur.
2 secondary outcomes
Sorting Task
Time frame: 36 months
Sense of Agency Questionnaire
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. Significant scientific results and data will be shared. Final data sets will include information such as survey results, de-identified aggregate data of prosthetic users' abilities and functional outcomes, de-identified photographic/video. Non-proprietary/non-identifying data and findings will be disseminated in a timely manner through scientific seminars, meetings, and peer reviewed publications.
Related trials for Prosthesis User
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Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
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Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
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Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
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Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
Amputation, Prosthesis User
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.
Paul Marasco, PhD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Tactor in people with Prosthesis User and Amputation, run by The Cleveland Clinic.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Skin or tendon location (time frame: 36 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 26 Aug 2026.