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

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

Treatments tested in this trial

  • MyoTrain
  • Motor Imagery

Treatment groups

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Infinite Biomedical Technologies

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Johns Hopkins University

Collaborator

Hanger Clinic: Prosthetics & Orthotics

Collaborator