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Robotic Orthosis
Robotic Arm Therapy for Spinal Cord Injury
Phase < 1
Recruiting
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between the ages of 18-80
Have full passive range of motion at the elbow as determined by study staff
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 10 weeks
Awards & highlights
Study Summary
This trial is testing a robot arm help people with spinal cord injuries improve movement and quality of life.
Who is the study for?
This trial is for adults aged 18-80 with a recent spinal cord injury (less than 3 months ago) who can perform tasks for an hour and follow instructions in English. They must be medically stable, maintain their medication regimen, have full elbow motion, and sufficient upper arm strength. Excluded are those in other studies, with neurological issues besides SCI, severe psychiatric problems or hearing loss, seizure risk from medications, pregnant women, excessive spasticity or pain in limbs.Check my eligibility
What is being tested?
The study tests if combining the MyoMo robotic orthosis with visual and haptic feedback improves hand/wrist movement and daily activities better than using the MyoPro robot alone, games only or no intervention at all. Participants are randomly assigned to one of these groups to compare outcomes.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing devices like skin irritation or muscle fatigue during use. There's also a small chance of increased spasticity due to repetitive movements but specific risks will depend on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I can fully extend and bend my elbow.
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I am taking my prescribed medication regularly without major changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GRASSP
Muscle strength measurement
Range of motion of hands and arms
Secondary outcome measures
Brain signals measurement
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: controlExperimental Treatment2 Interventions
Receive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility.
Group II: MyoPro-VR/HM groupExperimental Treatment3 Interventions
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics.
Group III: MyoPro groupActive Control2 Interventions
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis only.
Group IV: VR/HM groupActive Control2 Interventions
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using VR-video games only.
Find a Location
Who is running the clinical trial?
Kessler FoundationLead Sponsor
173 Previous Clinical Trials
10,688 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures or epilepsy.I am between 18 and 80 years old.I struggle to follow complex instructions.I am not on medication that raises seizure risk with brain stimulation.I have skin conditions that prevent me from wearing the Myo-Pro device.I can fully extend and bend my elbow.My elbow or wrist is very stiff, as confirmed by the study team.I have or had tinnitus or severe hearing issues that were treated.I do not have severe mental health issues that would stop me from joining this study.I have a recent spinal cord injury classified as moderate to mild.I am taking my prescribed medication regularly without major changes.I can do activities for 60 minutes with breaks without feeling overly tired.I am either younger than 18 or older than 80.I have severe pain in my arm or hand that would stop me from participating in rehabilitation.I am a woman who can have children and will take a pregnancy test before joining the study.I do not have any health issues that would make using the study device unsafe or ineffective for me.I can move my upper arm and forearm strongly as confirmed by a therapist.
Research Study Groups:
This trial has the following groups:- Group 1: MyoPro-VR/HM group
- Group 2: MyoPro group
- Group 3: VR/HM group
- Group 4: control
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.
Is the age criteria for this clinical experiment limited to individuals over 60 years of age?
"This medical research project accepts participants who are of legal age and below the age of 80."
Answered by AI
Are fresh participants being accepted into this research endeavor at the moment?
"Clinicaltrials.gov reveals that this clinical research is still in the process of recruiting patients, having gone live on April 1st 2021 and updated as recently as May 23rd 2022."
Answered by AI
How many participants are currently engaged in this research project?
"Indeed, clinicaltrials.gov data confirms that this medical study is presently recruiting participants. This trial was first posted on April 1st 2021 and has been revised most recently on the 23rd of May 2022. The team needs to enroll 20 patients from one location."
Answered by AI
Who has the necessary qualifications to participate in this experiment?
"This investigation is currently recruiting up to 20 volunteers between the ages of 18-80 who have suffered a spinal cord injury (iSCI (ASIA Impairment Scale AIS C and D) which occurred within 3 months prior. Participants must possess adequate muscular strength in their upper arms and forearms, remain medically stable, understand English instructions, take any prescribed medication without major changes in dosage, be able to complete functional tasks for 60 minutes with rest breaks as needed, demonstrate full passive range of motion at the elbow according to study staff assessment."
Answered by AI
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