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Active Hand Orthosis
Hand Orthosis for Spinal Cord Injury
N/A
Recruiting
Led By Joel Stein, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years at study completion
Awards & highlights
Study Summary
This trial is to test a new device that may help people with hand function after a spinal cord injury.
Who is the study for?
This trial is for individuals with C6-C7 spinal cord injury who are at least 6 months post-injury and have significantly reduced hand and finger function. They must be able to consent to the study. People with open wounds, severe upper limb pain, intense spasticity, or fixed contractures that limit arm use cannot participate.Check my eligibility
What is being tested?
The MyHand-SCI trial is testing a device designed to help people with specific spinal cord injuries regain hand functions. Participants will use the MyHand-SCI orthosis, which aims to improve their ability to perform daily tasks by enhancing motor control and strength in their hands.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the device, skin irritation where it contacts the body, muscle fatigue due to new movements or extended usage of the device, and possible exacerbation of existing spasticity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hand and finger control is greatly reduced due to my spinal cord injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years at study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years at study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
System Usability Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: MyHand-SCI Device TestingExperimental Treatment1 Intervention
Subjects will attend 1-20 sessions (of approximately 90 mins) to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,933 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,324 Total Patients Enrolled
Joel Stein, MDPrincipal InvestigatorColumbia University
7 Previous Clinical Trials
158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot use my hand or arm well because they are stiff and cannot move.My hand and finger control is greatly reduced due to my spinal cord injury.I have open wounds or my skin tears easily.I have constant severe pain in my arm.I have a spinal cord injury at C6-C7 and my arms don't work well, 6 months after the injury.I have severe muscle stiffness in my arm or hand.
Research Study Groups:
This trial has the following groups:- Group 1: MyHand-SCI Device Testing
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.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05553457 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still a possibility to join this experiment?
"Affirmative, the information available from clinicaltrials.gov confirms that this experiment is still open to enrolment. It was initially posted on October 4th 2022 and adjusted most recently on November 9th of the same year. 40 prospective participants are sought for a single location."
Answered by AI
What is the current enrollment number for this clinical research project?
"Affirmative. According to the data hosted on clinicaltrials.gov, this experiment is actively recruiting for participants since it was first posted on October 4th 2022 and last updated on November 9th 2022. The trial requires 40 people from 1 medical practice."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Colorado
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
What are the details?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I would like to improve my self in better way. My son turns 18 on 2/11. He had a C-5 injury on August 28th. He has recently changed from an Asia B to an asia C. He has recenlty moved one finger, but that is all hand movement that he has.
PatientReceived 1 prior treatment
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