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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
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.
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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
865 Previous Clinical Trials
327,689 Total Patients Enrolled
University of AlbertaOTHER
889 Previous Clinical Trials
385,167 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My amputation site has not fully healed.I have wounds that have not healed.My health issues are under control, as confirmed by my doctor.My limb's condition affects my ability to fully participate in the study.I do not have unmanageable pain affecting my ability to participate in the study.I have major nerve or brain function issues.I have lost one arm at or above the wrist, and the area has healed.
Research Study Groups:
This trial has the following groups:- Group 1: MyoTrain AR System
- Group 2: Conventional Motor Imagery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being welcomed into the experiment?
"Correct. According to clinicaltrials.gov, this trial is presently attempting to recruit participants. It was initially posted on August 1st 2023 and the most recent update occurred on July 27th 2023. The medical study requires 10 individuals across a single site."
Answered by AI
Has recruitment for this trial already commenced?
"Affirmative. According to information posted on clinicaltrials.gov, this medical trial is still recruiting participants since its initial posting on August 1st 2023 and last edit on July 27th 23rd. The study seeks 10 patients from a single site."
Answered by AI
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