Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInfinite Biomedical Technologies

About this trial

The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system).

The investigators will test three hypotheses:

1. The use of MyoTrain results in skills transference to control of the final prosthesis 2. The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures 3. The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics

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 receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Trans-radial unilateral limb loss

Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist

Fluent in English

Age of 18 years or greater

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MyoTrain

    Device

    MyoTrain is a virtual prosthesis control training system. From a hardware perspective it consists of an Apple iPad tablet computer and an eight-channel EMG armband, based on the Element electrode platform, which interfaces with the tablet via Bluetooth™. From a software perspective, MyoTrain was developed in the cross-platform Unity 4.0 game development environment.

  • Motor Imagery

    Behavioral

    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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Prosthesis Wear Duration

Investigators will measure the mean duration of daily prosthesis wear as a proxy for improved prosthesis acceptance. Prosthesis wear time is defined as the time from when participants dons their prostheses to the time they doff their prostheses. The time points are detected by skin-electrode impedance measurements through the EMG electrodes.

Time frame
Days 35-206

Secondary outcomes

1

Assessment of Capacity for Myoelectric Control (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.

Time frame
Days 31, 35, 93, 149, and 206
2

Clothespin Relocation Test (CRT)

The CRT has been adapted from an arm training tool to create an instrument to measure hand function. The CRT is a timed task that measures the time taken to move three standard clothespins from three locations on a horizontal bar to a vertical bar. It tests at least two motor functions simultaneously: hand open/close and wrist pronation/supination.

Time frame
Days 31, 35, 93, 149, and 206
3

Module 2 of MyoTrain

At the onset of the task, a virtual hand is displayed, and a target appears in a location or orientation indicating the final target posture. The targets were specifically designed through iterative focus group testing to ensure they minimally occluded the hand and wrist position during the task. For hand grasp tasks, a translucent grey sphere represents the target location and a red sphere represents a marker tracking the virtual hand's finger position. For wrist pronation/supination tasks, a translucent grey bar appears in a target orientation and a red bar acts a visual marker indicating the virtual hand's current orientation. The goal of the task is to match the hand or wrist orientation with the target location or orientation, respectively. Four metrics are all measured during each task: Movement Completion Rate, Movement Completion Time, Number of Overshoots, and Path Efficiency. The task is failed if the participant does not complete the task within 10 seconds.

Time frame
Days 0, 31, 35, 93, 149, and 206
4

Patient-Reported Outcomes Measurement Information System (PROMIS)

PROMIS is a set of self-reported person-centered measures that evaluate and monitor physical, mental, and social health in adults and children developed by the National Institutes of Health (NIH) to improve outcome reporting across medical sciences. The PROMIS measures were designed to reduce administration time of patient reported outcomes through the use of algorithmically selected surveys. There are 5 instruments of PROMIS that we plan to use for this study: Social Isolation, Ability to Participate, Upper Limb Functionality, Physical Function, and Satisfaction Roles Activities. PROMIS measures are scored according a common metric called the T-score. Typically, the mean of 50 (standard deviation of 10) corresponds to the mean in normative U.S. population.

Time frame
Days 0, 31, 35, 93, 149, and 206

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Infinite Biomedical Technologies

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Johns Hopkins University

Collaborator

Hanger Clinic: Prosthetics & Orthotics

Collaborator