MyHand 2: An Active Hand Orthosis for Stroke Patients (MyHand 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04436042|
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Device: MyHand Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MyHand 2: An Active Hand Orthosis for Stroke Patients|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||July 2025|
Experimental: MyHand Treatment
Participants will use the MyHand device during repetitive grasp and release tasks.
Device: MyHand Device
These subjects may be asked to attend 1-10 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
- Device Usability and Utility Questionnaire Score [ Time Frame: Up to 1 year at study completion ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436042
|Contact: Michaela Fraser, MS, MPHfirstname.lastname@example.org|
|Contact: Joel Stein, MD||212-305-4818|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Joel Stein||Columbia University|