BridgeMD
Tests treatment safety and results for Amputation
Official title Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
ClinicalTrials.gov ID: NCT05888428
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.