Clinical trial NCT05888428: Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
Official title: Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Upper Limb
Keywords: amputation
upper limb
myoelectric
training
prosthesis
Lead sponsor: Infinite Biomedical Technologies
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Johns Hopkins University
name: Hanger Clinic: Prosthetics & Orthotics
First posted: 2023-06-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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: 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

Primary outcomes:
measure: Mean Prosthesis Wear Duration
timeFrame: Days 35-206
Secondary outcomes:
measure: Assessment of Capacity for Myoelectric Control (ACMC)
timeFrame: Days 31, 35, 93, 149, and 206
measure: Clothespin Relocation Test (CRT)
timeFrame: Days 31, 35, 93, 149, and 206
measure: Module 2 of MyoTrain
timeFrame: Days 0, 31, 35, 93, 149, and 206
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Days 0, 31, 35, 93, 149, and 206
measure: Daily Mean Number of Movement Bouts
timeFrame: Days 35-206
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Hanger Clinic - Grand Rapids
state: Michigan
Study officials:
References: