AmputationNCT05975970
A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes
A study testing MyoTrain AR and Motor Imagery in people with Amputation and Upper Limb, run by Infinite Biomedical Technologies at 1 site in Canada.
Trial summary
The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Upper Limb
- What is being tested?
- MyoTrain AR and Motor Imagery
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2023to Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trans-radial unilateral limb loss with a healed residual limb
- Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
- Fluent in English
- Age of 18 years or greater
Who cannot join
- Prior experience with pattern recognition control
- Patients with a residual limb that is unhealed from the amputation surgery
- Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
Show all 9Show fewer
- Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- Uncontrolled pain or phantom pain impactive full participation in the study as determined upon clinical evaluation
- Serious uncontrolled medical problems as judged by the project therapist
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2R3
Jacqueline Hebert, MD, FRCPC, (780) 492-7846, jhebert@ualberta.ca
About this study
The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days. These individuals will be randomized to Group A (Control Group using conventional motor imagery exercises) and Group B (who will train with the MyoTrain AR system pre-prosthetically).
The investigators will test the following hypothesis: Pre-prosthetic training with the MyoTrain AR system, as compared to the current standard of care with conventional motor imagery exercises, results in improved subsequent control stability with the prosthesis.
Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will repeat the functional assessment. Participants will then receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo a battery of validated, clinical assessments.
- Conditions
- Amputation, Upper Limb
- Being tested
- MyoTrain AR, Motor Imagery
- Keywords
- amputation, upper limb, myoelectric, training, prosthesis, augmented reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoTrain ARDevice
MyoTrain AR is a virtual prosthesis functional training system. From a hardware perspective it consists of an augmented reality head-mounted display (HMD), four SteamVR kinematic trackers, eight surface EMG electrodes based on the Element electrode platform, and a desktop computer to facilitate wireless communication between the various hardware components. From a software perspective, MyoTrain AR was developed in the cross-platform Unity 4.0 game development engine.
Motor ImageryBehavioural
Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.
| Study group | Role | What they receive |
|---|---|---|
| MyoTrain AR System | Experimental | Participants will undergo functional task training using the MyoTrain AR system, which includes the HoloLens 2 augmented reality head-mounted display, four HTC VIVE SteamVR kinematic trackers, eight surface EMG electrodes based on the Element hardware platform, and a desktop computer. Participants will be prompted to use a pattern recognition-based myoelectric controller to operate a virtual prosthesis and complete a simulation of the GaMA Cup Transfer Task. Receives: Device: MyoTrain AR |
| Conventional Motor Imagery | Active comparator | Participants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback or functional assessment. Receives: Behavioral: Motor Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
GaMA Cup Transfer Task Mean Completion Time
The time to successfully complete the entire task trial (all 4 cup movements) from start to finish; averaged over all successful trials.
Measured: Day 35
GaMA Cup Transfer Task Mean Relative Grasp Duration
The percentage time spent in grasp phase relative to the entire movement (each movement involves reach-grasp-transport-release phases). This measure compensates for the expected inter-relation of absolute grasp duration with overall time, specifically identifying if grasp (object handling) is the main culprit in overall prolonged movement times.
Measured: Day 35
Secondary outcomes (3)
Assessment of Capacity for Myoelectric Controls (ACMC)
In contrast to other instruments, the ACMC does not require a specific set of tools or tasks. Instead, the proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are "the need for external support," "grip force and opening width," "coordination of both hands, "in different positions and in motion (timing)," "repetitive grip and release," and "the need for visual feedback." Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. This outcome measure permits evaluation of bimanual tasks as well as different planes and work spaces of prosthesis use.
Measured: Day 35
GaMA Cup Transfer Task Completion Rate
Percentage of successful trials out of 10 attempts. Note that errors (unsuccessful trials) may include not grasping the cup, or dropping or crushing the cup while in transport. This metric is therefore a general (non-specific) indication of grasp stability throughout the functional task. Errors other than grasp stability can result in an unsuccessful trial (hitting the barrier during transport, knocking a cup over during release, performing task in the wrong sequence) therefore type of error will also be tracked.
Measured: Day 35
GaMA Cup Transfer Task Wrist Activation
The ability to coordinate two DoF (hand + wrist movements) is measured by the degree of active wrist rotation from neutral (starting) position at the time of grasp initiation. This measure will identify if there is coordinated use of wrist rotation at the appropriate movement time (at the end of the reach phase) in order to facilitate grasp.
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start2 Oct 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infinite Biomedical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, University of Alberta
- Responsible party
- Principal investigator, Rahul Kaliki, Infinite Biomedical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975970
- Sponsor's protocol ID
- W81XWH2010919
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes
- ClinicalTrials.gov ID
- NCT05975970
- Acronym / sponsor ID
- W81XWH2010919
- Conditions
- Amputation, Upper Limb
- Keywords
- amputation, upper limb, myoelectric, training, prosthesis, augmented reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Infinite Biomedical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, University of Alberta
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 4 Aug 2023 (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 investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days. These individuals will be randomized to Group A (Control Group using conventional motor imagery exercises) and Group B (who will train with the MyoTrain AR system pre-prosthetically).
The investigators will test the following hypothesis: Pre-prosthetic training with the MyoTrain AR system, as compared to the current standard of care with conventional motor imagery exercises, results in improved subsequent control stability with the prosthesis.
Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will repeat the functional assessment. Participants will then receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo a battery of validated, clinical assessments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyoTrain AR System | Experimental | Device: MyoTrain ARParticipants will undergo functional task training using the MyoTrain AR system, which includes the HoloLens 2 augmented reality head-mounted display, four HTC VIVE SteamVR kinematic trackers, eight surface EMG electrodes based on the Element hardware platform, and a desktop computer. Participants will be prompted to use a pattern recognition-based myoelectric controller to operate a virtual prosthesis and complete a simulation of the GaMA Cup Transfer Task. |
| Conventional Motor Imagery | Active comparator | Behavioral: Motor ImageryParticipants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback or functional assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Trans-radial unilateral limb loss with a healed residual limb
- Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
- Fluent in English
- Age of 18 years or greater
Key exclusion criteria (9 listed)
- Prior experience with pattern recognition control
- Patients with a residual limb that is unhealed from the amputation surgery
- Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined upon clinical evaluation
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 |
|---|---|---|
| MyoTrain ARMyoTrain AR is a virtual prosthesis functional training system. From a hardware perspective it consists of an augmented reality head-mounted display (HMD), four SteamVR kinematic trackers, eight surface EMG electrodes based on the Element electrode platform, and a desktop computer to facilitate wireless communication between the various hardware components. From a software perspective, MyoTrain AR was developed in the cross-platform Unity 4.0 game development engine. | Device | MyoTrain AR System |
| Motor ImageryMotor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement. | Behavioural | Conventional Motor Imagery |
Primary outcome
GaMA Cup Transfer Task Mean Completion Time
Time frame: Day 35
The time to successfully complete the entire task trial (all 4 cup movements) from start to finish; averaged over all successful trials.
GaMA Cup Transfer Task Mean Relative Grasp Duration
Time frame: Day 35
The percentage time spent in grasp phase relative to the entire movement (each movement involves reach-grasp-transport-release phases). This measure compensates for the expected inter-relation of absolute grasp duration with overall time, specifically identifying if grasp (object handling) is the main culprit in overall prolonged movement times.
3 secondary outcomes
Assessment of Capacity for Myoelectric Controls (ACMC)
Time frame: Day 35
GaMA Cup Transfer Task Completion Rate
Time frame: Day 35
GaMA Cup Transfer Task Wrist Activation
Time frame: Day 35
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoTrain AR and Motor Imagery in people with Amputation and Upper Limb, run by Infinite Biomedical Technologies at 1 site in Canada.
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 4 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 10 Jan 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rahul R Kaliki, Ph.D ((443) 451-7175, rahul@i-biomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GaMA Cup Transfer Task Mean Completion Time (time frame: Day 35). The study lists 2 primary outcomes in all. 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 10 Jan 2024.