AmputationNCT03097978
Comparison of Pattern Recognition Control and Direct Control in TMR
A study testing Commercial system, RIC arm system and Pattern Recognition in people with Amputation and Amputation; Traumatic, Arm, Upper, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Targeted Muscle Reinnervation increases the control signals available for commercial arm systems. A new type of control, pattern recognition, has been developed into a form that allows use with commercially available arm system. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Amputation, Amputation; Traumatic, Arm, Upper
- What is being tested?
- Commercial system, RIC arm system and Pattern Recognition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 29 Sep 2017
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A upper limb amputation at the transhumeral or shoulder-disarticulation level
- Successful TMR surgery
- Previous success at operating a myoelectric prosthesis using surface EMG signals from reinnervated muscles (not necessarily current prosthesis usage, although current prosthesis users may be more likely to use their trial prostheses).
Who cannot join
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study. Of note, all TMR patients to date have normal cognitive function and we are not aware of any new brain injuries that would preclude participation
- Significant other co morbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: Clinical Trials of Pattern Recognition, Electrode Grid, RIC Arm in TMR Subjects
Targeted Muscle Reinnervation increases the control signals available for commercial arm systems. A new type of control, pattern recognition, has been developed into a form that allows use with commercially available arm system. The goal of this project is a home trial, in which people who have had TMR will try the new controls and the new arm to find out if they are better than what is currently available. Home trials will also allow us to see what needs to be done to make our inventions work even better.
Read the detailed description
Subjects who participate return to RIC several times (approximately 6-8 times) to undergo any necessary training and testing. Each visit will last from 2-5 days. The study will include use of up to three different prosthesis control systems at home for approximately 6 weeks each. The order of the systems will be randomized.
The first visit will allow us to cast the subject's residual limb for a socket and measure for a gel liner to be made with embedded electrode contacts prior to the next return. The socket interface will be fit for optimal comfort and a suspension sleeve and/or other straps, fasters, etc to best hold the prosthesis securely on the residual limb for the activities required. Unless changes are needed due to changes in limb volume, the same socket can be used for all phases of the study. During the initial and subsequent visits, subjects may practice the various control methods using a virtual reality system. EMG data and virtual "games" will be used to practice the control and will provide quantitative data that can be used to assess the various control methods mathematically, without the prosthesis.
Each phase of the study (up to 4 phases), will include preliminary training and testing at RIC lasting for 1-5 days, followed by approximately 6 weeks of at-home use of the system. After this time subjects will return to the RIC for 2-3 days of testing. They will then be trained and pre-tested in use of the next control during the same visit or at a later date. These systems include a commercially available myoelectric prosthesis with standard control, a commercially available device with advanced control (called pattern recognition), a commercially available device with pattern recognition and a new electrode configuration. Photographs or video recordings will be made during participation in this research study. These pictures and video recordings are essential for proper data analysis.
During the at-home use periods subjects will go about their daily business using the test prosthesis and will be asked document the experience with the prosthesis via weekly phone communication with study staff. Dates/times will be coordinated during normal business hours At the end of the at-home use period subjects will return to RIC for 3-5 days, where they will be asked to complete a questionnaire about how the prosthesis worked, and will undergo some non-invasive testing to see how well they can control and use the prosthesis.
- Conditions
- Amputation, Amputation; Traumatic, Arm, Upper
- Being tested
- Commercial system, RIC arm system, Direct Control, Pattern Recognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial systemDevice
Transhumeral amputees who have had TMR will use a commercially available prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control.
RIC arm systemDevice
Transhumeral amputees who have had TMR will use the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control.
Direct ControlOther
Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct control.
Pattern RecognitionOther
Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for pattern recognition control.
| Study group | Role | What they receive |
|---|---|---|
| RIC arm system with pattern recognition | Experimental | Subject will be fit with a custom socket and receive training on pattern recognition with the RIC arm prosthesis. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. Receives: Device: RIC arm system; Other: Pattern Recognition |
| RIC arm system with direct control | Experimental | Subject will be fit with a custom socket and receive training on direct control with the RIC arm prosthesis. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. Receives: Device: RIC arm system; Other: Direct Control |
| Commercial system with PR control | Experimental | Subject will be fit with a custom socket and receive training on pattern recognition with a conventional, commercial prosthesis system. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. Receives: Device: Commercial system; Other: Pattern Recognition |
| Commercial system with Direct Control | Experimental | Subject will be fit with a custom socket and receive training on direct control with a conventional, commercial prosthesis system. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. Receives: Device: Commercial system; Other: Direct Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern recognition and the RIC arm system will demonstrate a significant improvement over exiting technology.
Improved control of prosthesis as seen through functional use improvements.
Measured: 15 months from initial enrollment
Secondary outcomes (4)
Modified Box and Blocks
Timed task to assess prosthetic control.
Measured: At 1 month, 2 months, 4 months, 6 months
Jebsen Test of Hand Function
7 part timed diagnostic test to determine the level of hand function
Measured: At 1 month, 2 months, 4 months, 6 months
Southampton Hand Assessment Procedure (SHAP)
The test consists of the manipulation of a series of both lightweight and heavyweight abstract objects. The procedure is designed to provide a score of functionality.
Measured: At 1 month, 2 months, 4 months, 6 months
ACMC
Assessment of capacity for myoelectric prosthetic control
Measured: At 1 month, 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startJun 2013
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Todd Kuiken, Shirley Ryan AbilityLab
- Investigators
- Todd Kuiken, MD, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097978
- Sponsor's protocol ID
- STU00068547
- Status last verified
- Feb 2018
- First submitted
- 27 Mar 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hargrove L, Miller L, Turner K, Kuiken T. Control within a virtual environment is correlated to functional outcomes when using a physical prosthesis. J Neuroeng Rehabil. 2018 Sep 5;15(Suppl 1):60. doi: 10.1186/s12984-018-0402-y.
PubMed 30255800
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials of Pattern Recognition, Electrode Grid, RIC Arm in TMR Subjects
- ClinicalTrials.gov ID
- NCT03097978
- Acronym / sponsor ID
- STU00068547
- Conditions
- Amputation, Amputation; Traumatic, Arm, Upper
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jun 2013 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 31 Mar 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.
Targeted Muscle Reinnervation increases the control signals available for commercial arm systems. A new type of control, pattern recognition, has been developed into a form that allows use with commercially available arm system. The goal of this project is a home trial, in which people who have had TMR will try the new controls and the new arm to find out if they are better than what is currently available. Home trials will also allow us to see what needs to be done to make our inventions work even better.
Detailed description
Subjects who participate return to RIC several times (approximately 6-8 times) to undergo any necessary training and testing. Each visit will last from 2-5 days. The study will include use of up to three different prosthesis control systems at home for approximately 6 weeks each. The order of the systems will be randomized.
The first visit will allow us to cast the subject's residual limb for a socket and measure for a gel liner to be made with embedded electrode contacts prior to the next return. The socket interface will be fit for optimal comfort and a suspension sleeve and/or other straps, fasters, etc to best hold the prosthesis securely on the residual limb for the activities required. Unless changes are needed due to changes in limb volume, the same socket can be used for all phases of the study. During the initial and subsequent visits, subjects may practice the various control methods using a virtual reality system. EMG data and virtual "games" will be used to practice the control and will provide quantitative data that can be used to assess the various control methods mathematically, without the prosthesis.
Each phase of the study (up to 4 phases), will include preliminary training and testing at RIC lasting for 1-5 days, followed by approximately 6 weeks of at-home use of the system. After this time subjects will return to the RIC for 2-3 days of testing. They will then be trained and pre-tested in use of the next control during the same visit or at a later date. These systems include a commercially available myoelectric prosthesis with standard control, a commercially available device with advanced control (called pattern recognition), a commercially available device with pattern recognition and a new electrode configuration. Photographs or video recordings will be made during participation in this research study. These pictures and video recordings are essential for proper data analysis.
During the at-home use periods subjects will go about their daily business using the test prosthesis and will be asked document the experience with the prosthesis via weekly phone communication with study staff. Dates/times will be coordinated during normal business hours At the end of the at-home use period subjects will return to RIC for 3-5 days, where they will be asked to complete a questionnaire about how the prosthesis worked, and will undergo some non-invasive testing to see how well they can control and use the prosthesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RIC arm system with pattern recognition | Experimental | Device: RIC arm system, Other: Pattern RecognitionSubject will be fit with a custom socket and receive training on pattern recognition with the RIC arm prosthesis. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
| RIC arm system with direct control | Experimental | Device: RIC arm system, Other: Direct ControlSubject will be fit with a custom socket and receive training on direct control with the RIC arm prosthesis. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
| Commercial system with PR control | Experimental | Device: Commercial system, Other: Pattern RecognitionSubject will be fit with a custom socket and receive training on pattern recognition with a conventional, commercial prosthesis system. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
| Commercial system with Direct Control | Experimental | Device: Commercial system, Other: Direct ControlSubject will be fit with a custom socket and receive training on direct control with a conventional, commercial prosthesis system. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A upper limb amputation at the transhumeral or shoulder-disarticulation level
- Successful TMR surgery
- Previous success at operating a myoelectric prosthesis using surface EMG signals from reinnervated muscles (not necessarily current prosthesis usage, although current prosthesis users may be more likely to use their trial prostheses).
Key exclusion criteria (3 listed)
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study. Of note, all TMR patients to date have normal cognitive function and we are not aware of any new brain injuries that would preclude participation
- Significant other co morbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.
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 |
|---|---|---|
| Commercial systemTranshumeral amputees who have had TMR will use a commercially available prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control. | Device | Commercial system with Direct Control, Commercial system with PR control |
| RIC arm systemTranshumeral amputees who have had TMR will use the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control. | Device | RIC arm system with direct control, RIC arm system with pattern recognition |
| Direct ControlTranshumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct control. | Other | Commercial system with Direct Control, RIC arm system with direct control |
| Pattern RecognitionTranshumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for pattern recognition control. | Other | Commercial system with PR control, RIC arm system with pattern recognition |
Primary outcome
Pattern recognition and the RIC arm system will demonstrate a significant improvement over exiting technology.
Time frame: 15 months from initial enrollment
Improved control of prosthesis as seen through functional use improvements.
4 secondary outcomes
Modified Box and Blocks
Time frame: At 1 month, 2 months, 4 months, 6 months
Jebsen Test of Hand Function
Time frame: At 1 month, 2 months, 4 months, 6 months
Southampton Hand Assessment Procedure (SHAP)
Time frame: At 1 month, 2 months, 4 months, 6 months
ACMC
Time frame: At 1 month, 2 months, 4 months, 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 23 Feb 2018.
- Derived from this study: PubMed 30255800Hargrove L, Miller L, Turner K, Kuiken T. Control within a virtual environment is correlated to functional outcomes when using a physical prosthesis. J Neuroeng Rehabil. 2018 Sep 5;15(Suppl 1):60. doi: 10.1186/s12984-018-0402-y.
- 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.
Todd Kuiken, MD, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial system, RIC arm system and Pattern Recognition in people with Amputation and Amputation; Traumatic, Arm, Upper, run by Shirley Ryan AbilityLab 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 3 inclusion and 3 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 23 Feb 2018. 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?
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?
Pattern recognition and the RIC arm system will demonstrate a significant improvement over exiting technology. (time frame: 15 months from initial enrollment). 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 NCT03097978, which also lists 1 linked publication.
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 23 Feb 2018.