AmputationeADAPTNCT04238533
Enhanced Auto-Diagnostic Adaptive Precision Trainer for Myoelectric Prosthetic Users
A study testing eADAPT training and Conventional training in people with Amputation, run by University of South Florida at 1 site in United States.
Trial summary
The eADAPT training consists of a variety of mobile games played on a mobile app (phone or tablet). A band is worn on the residual limb. Participants use muscle activation to send signals to execute certain movements in the game. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- eADAPT training and Conventional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2020to 31 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Amputation or missing limb at or above the wrist and below the elbow (transradial)
- Current myoelectric prosthesis user
- Sufficient neurological and cognitive function to operate the prosthesis effectively as assessed by research personnel during initial interviews;
- Sufficient neurological and cognitive function to operate a mobile device (phone, tablet) effectively;
- The patient is free of comorbidities that could interfere with the function of the prosthesis;
- Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual when performing activities of daily living
- Age 18-70 years
- Able to independently read, speak and understand English for the purpose of consent, following instructions and completing surveys
Who cannot join
- Amputation or missing limb at a level that is not above the wrist and below the elbow (transradial)
- Not currently a myoelectric user
- Insufficient neurological and cognitive function to operate the prosthesis effectively as assessed by research personnel during initial interviews;
- Insufficient neurological and cognitive function to operate a mobile device (phone, tablet) effectively
- The patient has comorbidities that could interfere with function of the prosthesis;
- Functional evaluation indicates that despite training, use of a myoelectric prosthesis is unlikely to meet the functional needs of the individual when performing activities of daily living;
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- Age <18 or >70 years
- Participants with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the study procedure, or the ability to obtain relevant user feedback.
- Unable to independently read, speak and understand English for the purpose of consent, following instructions, and completing surveys
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James A Haley VA
Tampa, Florida, 33612
Anita Ramrattan, DPT, 813-270-7645, anita.ramrattan@va.gov
About this study
The eADAPT training consists of a variety of mobile games played on a mobile app (phone or tablet). A band is worn on the residual limb. Participants use muscle activation to send signals to execute certain movements in the game.
Read the detailed description
Myoelectric prostheses provide upper limb movement control using electromyography (EMG) electrodes on the residual muscles to control arm and hand movements. Within the current generation of advanced prostheses, research has shown that most amputees rely on assistive devices rather than prostheses (27 - 54% use prostheses), and many users do not use all available features or stop using the device altogether. Part of the difficulty in learning to control upper limb myoelectric prostheses stems from the sequences of muscle inputs required to choose grips and modes, and move the limb.
Myoelectric prosthetic limbs can aide in regaining lost capabilities, but require intensive training to effectively operate. Learning to use a myoelectric prosthesis involves significant motor cortex plasticity and learning how to consciously control muscle contraction, level of activation, and isolation through repetitive exercises. The need to concentrate and continuously react during training is expected to decrease with use, but often takes amputees many months, with the result being that many users abandon the prosthesis before mastery is achieved.
Difficult training has been identified as a primary reason for low user acceptance.
Current training methods and tools can be expensive, are limited in their activation sites, transferability, and personalized training capabilities. Current one-size-fits-all training cannot be personalized for the patient, thereby ignoring or being unresponsive to their learning ability. This limitation factor reduces the level of acute positive patient outcomes that can be achieved. A need therefore exists for myoelectric training tools that are affordable, reliable, support conventional and state-of-the-art control schemes, adaptable to various patient needs, can improve patient clinical outcomes, motivate patients to train, and be used in the clinic and remotely by the patient.
To fill the identified gaps in myoelectric training tools, Design Interactive, Inc. (DI) developed a prototype of the Auto Diagnostic Adaptive Precision Trainer for Myoelectric Prosthesis users (ADAPT-MP), an adaptive, game-based modular software solution paired with an innovative, mobile hardware solution to support the upper limb prosthesis training continuum, including basic pre-prosthetic training through advanced skill training using the prosthesis.
Rationale Current prosthetic training is monotonous, expensive, specific to certain devices, and often cannot be brought home. The eADAPT-MP system has multiple engaging games of varying levels of difficulty, is inexpensive, is designed to be manufacturer and device agnostic, and is a tool users can bring with them almost anywhere. The upper limb amputee patient population would benefit from having a powerful telerehabilitation tool that is engaging and encourages prosthetic training to reduce abandonment of myoelectric prostheses and promote usability of myoelectric arms. However, there is a lack of randomized, controlled clinical data supporting myoprosthetic training on functional outcomes. Previously published clinical research on the effect of pre-prosthetic training on amputee health outcomes is represented by small, uncontrolled case studies, or the reliance on non-amputee participants.
- Conditions
- Amputation
- Being tested
- eADAPT training, Conventional training
- Keywords
- transradial, upper extremity, amputee, forearm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eADAPT trainingOther
eADAPT training for myoelectric prosthesis users is the comparator training.
Conventional trainingOther
Conventional training with Myoboy has been the only training available to users.
| Study group | Role | What they receive |
|---|---|---|
| eADAPT | Active comparator | This arm includes transradial amputees who will be assessed while using the eADAPT trainer. Receives: Other: eADAPT training |
| Conventional program | Active comparator | This arm includes transradial amputees who will be assessed while using the conventional training program. Receives: Other: Conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Compliance with the respective training protocol. For conventional exercise, patients will be contacted by phone once per week and asked if they were compliant with the training protocol. For the experimental (eADAPT) training protocol, utilization time will be recorded via the app and available for download for analysis. The difference in compliance between the two protocols will be compared.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start18 Mar 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Design Interactive, Inc
- Responsible party
- Sponsor
- Investigators
- Jason Highsmith, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238533
- Sponsor's protocol ID
- Pro00041255
- Other IDs
- CDMRP-CDMRP OP160046
- Acronym
- eADAPT
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Auto-Diagnostic Adaptive Precision Trainer for Myoelectric Prosthetic Users
- ClinicalTrials.gov ID
- NCT04238533
- Acronym / sponsor ID
- eADAPT / Pro00041255
- Conditions
- Amputation
- Keywords
- transradial, upper extremity, amputee, forearm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Design Interactive, Inc
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 23 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.
The eADAPT training consists of a variety of mobile games played on a mobile app (phone or tablet). A band is worn on the residual limb. Participants use muscle activation to send signals to execute certain movements in the game.
Detailed description
Myoelectric prostheses provide upper limb movement control using electromyography (EMG) electrodes on the residual muscles to control arm and hand movements. Within the current generation of advanced prostheses, research has shown that most amputees rely on assistive devices rather than prostheses (27 - 54% use prostheses), and many users do not use all available features or stop using the device altogether. Part of the difficulty in learning to control upper limb myoelectric prostheses stems from the sequences of muscle inputs required to choose grips and modes, and move the limb.
Myoelectric prosthetic limbs can aide in regaining lost capabilities, but require intensive training to effectively operate. Learning to use a myoelectric prosthesis involves significant motor cortex plasticity and learning how to consciously control muscle contraction, level of activation, and isolation through repetitive exercises. The need to concentrate and continuously react during training is expected to decrease with use, but often takes amputees many months, with the result being that many users abandon the prosthesis before mastery is achieved.
Difficult training has been identified as a primary reason for low user acceptance.
Current training methods and tools can be expensive, are limited in their activation sites, transferability, and personalized training capabilities. Current one-size-fits-all training cannot be personalized for the patient, thereby ignoring or being unresponsive to their learning ability. This limitation factor reduces the level of acute positive patient outcomes that can be achieved. A need therefore exists for myoelectric training tools that are affordable, reliable, support conventional and state-of-the-art control schemes, adaptable to various patient needs, can improve patient clinical outcomes, motivate patients to train, and be used in the clinic and remotely by the patient.
To fill the identified gaps in myoelectric training tools, Design Interactive, Inc. (DI) developed a prototype of the Auto Diagnostic Adaptive Precision Trainer for Myoelectric Prosthesis users (ADAPT-MP), an adaptive, game-based modular software solution paired with an innovative, mobile hardware solution to support the upper limb prosthesis training continuum, including basic pre-prosthetic training through advanced skill training using the prosthesis.
Rationale Current prosthetic training is monotonous, expensive, specific to certain devices, and often cannot be brought home. The eADAPT-MP system has multiple engaging games of varying levels of difficulty, is inexpensive, is designed to be manufacturer and device agnostic, and is a tool users can bring with them almost anywhere. The upper limb amputee patient population would benefit from having a powerful telerehabilitation tool that is engaging and encourages prosthetic training to reduce abandonment of myoelectric prostheses and promote usability of myoelectric arms. However, there is a lack of randomized, controlled clinical data supporting myoprosthetic training on functional outcomes. Previously published clinical research on the effect of pre-prosthetic training on amputee health outcomes is represented by small, uncontrolled case studies, or the reliance on non-amputee participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eADAPT | Active comparator | Other: eADAPT trainingThis arm includes transradial amputees who will be assessed while using the eADAPT trainer. |
| Conventional program | Active comparator | Other: Conventional trainingThis arm includes transradial amputees who will be assessed while using the conventional training program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Amputation or missing limb at or above the wrist and below the elbow (transradial)
- Current myoelectric prosthesis user
- Sufficient neurological and cognitive function to operate the prosthesis effectively as assessed by research personnel during initial interviews;
- Sufficient neurological and cognitive function to operate a mobile device (phone, tablet) effectively;
- The patient is free of comorbidities that could interfere with the function of the prosthesis;
Key exclusion criteria (9 listed)
- Amputation or missing limb at a level that is not above the wrist and below the elbow (transradial)
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 |
|---|---|---|
| eADAPT trainingeADAPT training for myoelectric prosthesis users is the comparator training. | Other | eADAPT |
| Conventional trainingConventional training with Myoboy has been the only training available to users. | Other | Conventional program |
Primary outcome
Compliance
Time frame: 3 weeks
Compliance with the respective training protocol. For conventional exercise, patients will be contacted by phone once per week and asked if they were compliant with the training protocol. For the experimental (eADAPT) training protocol, utilization time will be recorded via the app and available for download for analysis. The difference in compliance between the two protocols will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- 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.
Jason Highsmith, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eADAPT training and Conventional training in people with Amputation, run by University of South Florida 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 8 inclusion and 9 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 12 Jan 2021. 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?
Contact Jason Highsmith, PhD (813-974-8530, mhighsmi@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 3 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 12 Jan 2021.