Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MyoTrain, Motor Imagery.
- Who it may be relevant to
- Registry conditions: Amputation, Upper Limb. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss
Overview
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.
Interventions
- Device MyoTrain
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. - Behavioral Motor Imagery
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.
Primary outcome measures
- Mean Prosthesis Wear Duration [Time frame: Days 35-206]
Secondary outcome measures (5)
- Assessment of Capacity for Myoelectric Control (ACMC) [Time frame: Days 31, 35, 93, 149, and 206]
- Clothespin Relocation Test (CRT) [Time frame: Days 31, 35, 93, 149, and 206]
- Module 2 of MyoTrain [Time frame: Days 0, 31, 35, 93, 149, and 206]
- Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: Days 0, 31, 35, 93, 149, and 206]
- Daily Mean Number of Movement Bouts [Time frame: Days 35-206]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Hanger Clinic - Grand Rapids — Grand Rapids
Identifiers
NCT: NCT05888428 · U44NS119842