Prosthesis UseMPLNCT02887690
Pilot Project to Evaluate the Revolutionizing Prosthetics Modular Prosthetic Limb System for Upper Extremity Amputees
A study testing Modular Prosthetic Limb in people with Prosthesis Use and Limb Loss, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The purpose of this study is to optimize the Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the performance, usability, and patient acceptance of the MPL in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Use, Limb Loss
- What is being tested?
- Modular Prosthetic Limb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 to 65 years of age with a unilateral or bilateral upper-limb amputation at any time prior to enrollment
- Active duty military, beneficiary, retiree, and civilian non-beneficiaries are all eligible to participate in this minimal risk study.
- If non active duty military, proof of verified, current health insurance in the form of a health insurance card must be provided in person and health plan expiration date not prior to the end of the projected study participation period will be verified.
- No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
- Ability to follow study instructions and likely to complete all required visits for both phases of the study.
- Normal neurological examination with the exception of limb amputation.
- Medically cleared to use a prosthetic device based on residual limb condition and overall health, including participants both with and without prior prosthetic experience.
Who cannot join
- Age less than 18 or greater than 65.
- Presence of mild to severe traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening that is currently performed routinely on patients by the TBI program at WRNMMCB and noted in the subject's medical record.
- Current, known uncontrolled systemic disease.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Subjects with lack of effort as determined by the research team. Subjects will be screened for effort using the Test of Malingering Memory (TOMM), with a score lower than 42/50 serving as exclusionary.
- Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
- Use of a pacemaker, so as to minimize the risk of surface electromyography interference.
- Lack of health insurance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
The purpose of this study is to optimize the Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the performance, usability, and patient acceptance of the MPL in a clinical setting. This study will be a non-randomized limited clinical optimization study. The study will consist of two phases. Up to twenty-four upper extremity amputees will be recruited in order to ensure twelve subjects for participation in the study: 6 trans-humeral amputees and 6 trans-radial amputees. During Phase 1, subjects will be evaluated for their potential to operate the MPL using a virtual limb controlled by signals from surface electromyograms (sEMG). The first six trans-humeral amputee subjects and the first six trans-radial amputee subjects with a demonstrated proficiency controlling the MPL based on analytical performance metrics will enter Phase 2. During Phase 2, each subject will be fitted for the prosthesis with a custom socket. The user will then evaluate the prosthesis during twelve 1- hour or 1 and one half-hour sessions, working with an occupational therapist and research associates and completing both quantitative and qualitative assessments.
- Conditions
- Prosthesis Use, Limb Loss
- Being tested
- Modular Prosthetic Limb
- Keywords
- MPL, prosthetic limb, upper extremity, prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular Prosthetic LimbDevice
Also called MPL
| Study group | Role | What they receive |
|---|---|---|
| Modular Prosthetic Limb | Experimental | The Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL) Receives: Device: Modular Prosthetic Limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPL functionality during clinical use
The overall objective of the study is to determine the functionality of the MPL during clinical use in training scenarios simulating activities of daily living, and to assess patient satisfaction of the MPL by individuals with upper extremity amputations. The results will be used to optimize control and features of the MPL based on qualitative and quantitative user driven feedback in a clinical setting.
Measured: From beginning to end of clinical testing period, evaluated up to four weeks
Secondary outcomes (1)
Optimally controlled degrees of freedom
We will functionally assess the number of optimally controlled degrees of freedom by having users perform comparative assessments using their existing prosthesis as a baseline, followed the MPL configured with increasing number of controllable degrees of freedom to accomplish functional activities of daily living.
Measured: From beginning to end of clinical testing period, evaluated up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Paul F Pasquina, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887690
- Sponsor's protocol ID
- 386304
- Acronym
- MPL
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2016
- Last updated
- 15 Mar 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project to Evaluate the Revolutionizing Prosthetics Modular Prosthetic Limb System for Upper Extremity Amputees
- ClinicalTrials.gov ID
- NCT02887690
- Acronym / sponsor ID
- MPL / 386304
- Conditions
- Prosthesis Use, Limb Loss
- Keywords
- MPL, prosthetic limb, upper extremity, prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Walter Reed National Military Medical Center
- Study start
- Dec 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Sep 2016 (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.
The purpose of this study is to optimize the Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the performance, usability, and patient acceptance of the MPL in a clinical setting. This study will be a non-randomized limited clinical optimization study. The study will consist of two phases. Up to twenty-four upper extremity amputees will be recruited in order to ensure twelve subjects for participation in the study: 6 trans-humeral amputees and 6 trans-radial amputees. During Phase 1, subjects will be evaluated for their potential to operate the MPL using a virtual limb controlled by signals from surface electromyograms (sEMG). The first six trans-humeral amputee subjects and the first six trans-radial amputee subjects with a demonstrated proficiency controlling the MPL based on analytical performance metrics will enter Phase 2. During Phase 2, each subject will be fitted for the prosthesis with a custom socket. The user will then evaluate the prosthesis during twelve 1- hour or 1 and one half-hour sessions, working with an occupational therapist and research associates and completing both quantitative and qualitative assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modular Prosthetic Limb | Experimental | Device: Modular Prosthetic LimbThe Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, 18 to 65 years of age with a unilateral or bilateral upper-limb amputation at any time prior to enrollment
- Active duty military, beneficiary, retiree, and civilian non-beneficiaries are all eligible to participate in this minimal risk study.
- If non active duty military, proof of verified, current health insurance in the form of a health insurance card must be provided in person and health plan expiration date not prior to the end of the projected study participation period will be verified.
- No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
- Ability to follow study instructions and likely to complete all required visits for both phases of the study.
Key exclusion criteria (8 listed)
- Age less than 18 or greater than 65.
- Presence of mild to severe traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening that is currently performed routinely on patients by the TBI program at WRNMMCB and noted in the subject's medical record.
- Current, known uncontrolled systemic disease.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Subjects with lack of effort as determined by the research team. Subjects will be screened for effort using the Test of Malingering Memory (TOMM), with a score lower than 42/50 serving as exclusionary.
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 |
|---|---|---|
| Modular Prosthetic LimbAlso: MPL | Device | Modular Prosthetic Limb |
Primary outcome
MPL functionality during clinical use
Time frame: From beginning to end of clinical testing period, evaluated up to four weeks
The overall objective of the study is to determine the functionality of the MPL during clinical use in training scenarios simulating activities of daily living, and to assess patient satisfaction of the MPL by individuals with upper extremity amputations. The results will be used to optimize control and features of the MPL based on qualitative and quantitative user driven feedback in a clinical setting.
1 secondary outcome
Optimally controlled degrees of freedom
Time frame: From beginning to end of clinical testing period, evaluated up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- 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.
Paul F Pasquina, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modular Prosthetic Limb in people with Prosthesis Use and Limb Loss, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
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 7 inclusion and 8 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 15 Mar 2019. 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 United States. 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?
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?
MPL functionality during clinical use (time frame: From beginning to end of clinical testing period, evaluated up to four weeks). 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 15 Mar 2019.