MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals with C6-C7 spinal cord injury, at least 6-months post-injury with impaired upper limb function
Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function
Able to provide informed consent
Disqualifiers
Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device
Severe spasticity (modified Ashworth >2) at elbow, wrist, or fingers
Any open wounds or unusual skin fragility
Persistent severe pain in their upper limb
Trial design
Design model
Single group
Treatments tested in this trial
Testing of MyHand-SCI Device
DeviceSubjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MyHand-SCI Device TestingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
System Usability Scale
The System Usability Scale (SUS) is a reliable tool for measuring the usability of products, including medical devices. It consists of a 10 item questionnaire with five response options (Strongly agree to Strongly disagree).
Time frame
Up to 2 years at study completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov