MyHand 2: An Active Hand Orthosis for Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
This study is designed to further develop and test the hardware and software components of the MyHand device based on user feedback and results from our pilot study. The goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults over 18 years old
History of stroke(s) with most recent stroke at least six months ago
Upper extremity weakness with impaired ability to complete daily activities with affected hand
Full passive range of motion in all digits
Disqualifiers
Other neurological conditions besides stroke
Other orthopedic conditions to affected upper extremity
Significant spasticity in affected upper extremity that impairs device fit
Trial design
Design model
Single group
Treatments tested in this trial
MyHand Device
DeviceThese subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: MyHand TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Usability and Utility Questionnaire Score
Subjects will provide feedback about their perceptions of the device's usability and utility for post-stroke upper extremity recovery. Four questions will be rated on a 5-point Likert scale (1) strongly agree to (5) strongly disagree. Five questions will be rated on a 5-point reverse Likert scale (1) strongly disagree to (5) strongly agree. The 9 question survey has a score range of 9-45 with higher scores indicating higher levels of device usability and utility.
Time frame
Up to 1 year 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