Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss

NCT05888428 | Recruiting DMC FDA Device

• 1 other identifier: U44NS119842
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.The use of MyoTrain results in skills transference to control of the final prosthesis
2. 2.The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures
3. 3.The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics

Conditions

Amputation; Upper Limb

Keywords

amputation; upper limb; myoelectric; training; prosthesis

Outcome Measures

Primary Outcomes (1)

• Mean Prosthesis Wear Duration

  Investigators will measure the mean duration of daily prosthesis wear as a proxy for improved prosthesis acceptance. Prosthesis wear time is defined as the time from when participants dons their prostheses to the time they doff their prostheses. The time points are detected by skin-electrode impedance measurements through the EMG electrodes.

  Days 35-206

Secondary Outcomes (5)

• Assessment of Capacity for Myoelectric Control (ACMC)

  Days 31, 35, 93, 149, and 206

• Clothespin Relocation Test (CRT)

  Days 31, 35, 93, 149, and 206

• Module 2 of MyoTrain

  Days 0, 31, 35, 93, 149, and 206

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  Days 0, 31, 35, 93, 149, and 206

• Daily Mean Number of Movement Bouts

  Days 35-206

Study Arms (2)

Experimental

EXPERIMENTAL

Participants will be provided with the take-home MyoTrain system, which includes the MyoTrain armband, iPad, and MyoTrain software. Participants will progress through the training modules of the MyoTrain software, starting with eliciting paired single DoF antagonistic movements and ending with the proportional control of complex, 2-DoF hand and wrist movements.

Device: MyoTrain

Control

ACTIVE COMPARATOR

Participants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback.

Behavioral: Motor Imagery

Interventions

MyoTrain DEVICE

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.

Experimental

Motor Imagery BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
• 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

Sponsors & Collaborators

• Infinite Biomedical Technologies: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Johns Hopkins University: collaborator
• Hanger Clinic: Prosthetics & Orthotics: collaborator

Study Sites (1)

Hanger Clinic - Grand Rapids

Grand Rapids, Michigan, 49546, United States

RECRUITING

Central Study Contacts

Rahul R Kaliki

CONTACT

443-451-7175; rahul@i-biomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Executive Officer

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 5, 2023
• Study Start: February 2, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)