What side effects are associated with this type of intervention?

The most common treatments for amputation, particularly those involving pre-prosthetic training like the MyoTrain AR system, generally have minimal side effects. Augmented reality-based systems and myoelectric pattern recognition technologies are designed to enhance motor control and do not typically cause significant adverse effects. However, users may experience mild discomfort or fatigue from extended use of the system. Conventional motor imagery exercises, used as a control in the MyoTrain AR study, are also low-risk but may lead to mental fatigue or frustration if progress is slow. Overall, these pre-prosthetic training methods are considered safe with few reported side effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments directly comparable to the MyoTrain AR system for augmented reality-based pre-prosthetic training in amputees. However, there are various FDA-approved devices and therapies aimed at improving the quality of life for amputees, such as advanced prosthetic limbs and rehabilitation technologies. These include myoelectric prostheses, which use electrical signals from the residual limb muscles to control the prosthetic, and virtual reality systems for pain management and rehabilitation. These technologies aim to enhance motor control, sensory feedback, and overall functionality for amputees.

What other types of research exist?

Promising, novel alternatives to MyoTrain AR for amputation patients in 2024 include: 1) Virtual Reality (VR)-based rehabilitation systems, which provide immersive environments for motor imagery and control training. 2) Advanced myoelectric prostheses with integrated biofeedback systems that enhance user control and adaptability. 3) Brain-Computer Interface (BCI) technologies that allow direct neural control of prosthetic limbs, improving precision and response times. 4) Robotics-assisted rehabilitation devices that offer precise, repetitive motion training to enhance muscle memory and control stability.

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Augmented Reality Rehabilitation for Upper Limb Amputees

N/A

Recruiting

Research Sponsored by Infinite Biomedical Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 35

Awards & highlights

Study Summary

This trial will test if a new technology (MyoTrain AR) can improve prosthetic control in people with upper limb loss.

Who is the study for?

This trial is for adults over 18 with a healed trans-radial amputation who are candidates for an advanced myoelectric prosthesis. They must speak English and have no prior experience with pattern recognition control, unhealed wounds, sensitive skin issues, significant cognitive or neurological deficits, or uncontrolled pain that could affect participation.Check my eligibility

What is being tested?

The study compares the MyoTrain AR system's effectiveness against conventional motor imagery exercises in improving control stability of prosthetic devices. Participants will be randomly assigned to either continue standard care or use the new MyoTrain AR system before getting their prosthesis.See study design

What are the potential side effects?

While not explicitly mentioned, potential side effects may include discomfort from wearing EMG electrodes for those with sensitive skin and possible frustration or fatigue during training sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 35

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 35

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GaMA Cup Transfer Task Mean Completion Time

GaMA Cup Transfer Task Mean Relative Grasp Duration

Secondary outcome measures

Assessment of Capacity for Myoelectric Controls (ACMC)

GaMA Cup Transfer Task Completion Rate

GaMA Cup Transfer Task Wrist Activation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MyoTrain AR SystemExperimental Treatment1 Intervention

Participants will undergo functional task training using the MyoTrain AR system, which includes the HoloLens 2 augmented reality head-mounted display, four HTC VIVE SteamVR kinematic trackers, eight surface EMG electrodes based on the Element hardware platform, and a desktop computer. Participants will be prompted to use a pattern recognition-based myoelectric controller to operate a virtual prosthesis and complete a simulation of the GaMA Cup Transfer Task.

Group II: Conventional Motor ImageryActive Control1 Intervention

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 or functional assessment.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for amputation, such as the MyoTrain AR system, utilize augmented reality (AR) and myoelectric pattern recognition to improve prosthetic control. AR creates an interactive environment for patients to practice motor skills, while myoelectric pattern recognition uses sensors to detect muscle activity in the residual limb to control the prosthesis. These technologies enhance the precision and stability of prosthetic movements, which is vital for amputation patients as it significantly improves their rehabilitation outcomes and daily functionality with the prosthetic device.

Immersive Low-Cost Virtual Reality Treatment for Phantom Limb Pain: Evidence from Two Cases.Treatment of phantom limb pain (PLP) based on augmented reality and gaming controlled by myoelectric pattern recognition: a case study of a chronic PLP patient.

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Who is running the clinical trial?

Infinite Biomedical TechnologiesLead Sponsor

5 Previous Clinical Trials

146 Total Patients Enrolled

United States Department of DefenseFED

869 Previous Clinical Trials

327,692 Total Patients Enrolled

University of AlbertaOTHER

897 Previous Clinical Trials

387,153 Total Patients Enrolled

Media Library

Motor Imagery (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05975970 — N/A

Amputation Research Study Groups: Conventional Motor Imagery, MyoTrain AR System

Amputation Clinical Trial 2023: Motor Imagery Highlights & Side Effects. Trial Name: NCT05975970 — N/A

Motor Imagery (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975970 — N/A

~3 spots leftby Sep 2024

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