Evaluating the MyoTrain System for Individuals with Trans-radial Limb Loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy of the MyoTrain system in individuals who have experienced trans-radial upper-limb loss. Sixteen participants will be randomly assigned to either a control group using standard motor imagery training or a group utilizing the MyoTrain system over a 206-day period. The study will evaluate the transfer of skills to prosthetic control, the correlation of virtual outcome measures with real-world functional outcomes, and improvements in clinical outcomes through various metrics. Participants will undergo a pre-prosthetic training period before receiving their prosthetic devices and occupational therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Hanger Clinic - Grand Rapids
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Rahul R Kaliki
• Email: rahul@i-biomed.com
• Phone: 443-451-7175

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.