Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT05376332
Eligibility Criteria:
Inclusion Criteria:
* Transradial unilateral amputation
* Fluent in English
* For active comparator intervention 1 (myoelectric direct control prosthesis): Naïve to use of myoelectric prosthesis (i.e., uses body-powered prosthesis or has not used a myoelectric prosthesis for at least 3 years)
* For active comparator intervention 2 (myoelectric pattern recognition control prosthesis): Currently uses a commercially-available pattern recognition system (IBT Sense) with a terminal device having at least two degrees of freedom
Exclusion Criteria:
* 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 impacting full participation in the study as determined upon OT evaluation
* Serious uncontrolled medical problems as judged by the project therapist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05376332
Study Brief:
Protocol Section:
NCT05376332