MyHand: An Active Hand Orthosis for Stroke Patients
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|ClinicalTrials.gov Identifier: NCT03767894|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : January 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: EMG Band Device: Shoulder harness||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.|
|Official Title:||MyHand: An Active Hand Orthosis for Stroke Patients|
|Actual Study Start Date :||November 13, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: MyHand orthosis
Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.
Device: EMG Band
The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.
Device: Shoulder harness
The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
- Score on Action Research Arm Test (ARAT) [ Time Frame: 4 Weeks ]The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 indicating cannot perform to 3, indicating performs test normally. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
- Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) [ Time Frame: 4 Weeks ]The UEFM evaluates and measures recovery in post-stroke hemiplegic patients. There are a total of 5 domains, and each item is scored on a 3-point ordinal scale, with 0 indicating cannot perform to 3, indicating performs fully. The maximum score for all 5 domains is 226, with a higher score indicating better performance.
- Score on Modified Ashworth Scale (MAS) [ Time Frame: 4 Weeks ]The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 - 'no increases in tone' to 4 - 'limb rigid in flexion or extension [abduction/adduction]'.
- Score on Box and Blocks Test (BBT) [ Time Frame: 4 Weeks ]The BBT measures unilateral gross manual dexterity. Individuals are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds and each hand is scored separately. Higher scores are indicative of better manual dexterity.
- Treatment Adherence Rate [ Time Frame: 4 Weeks ]This rate will be measured by patient attendance/ability to complete full treatment protocol
- Total Number of Adverse Events During Intervention [ Time Frame: 4 Weeks ]All adverse events will be tracking during the course of the intervention.
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): NCT03767894
|Contact: Joel Stein, MD||(212) email@example.com|
|Contact: Michaela Fraser, MS, MPHfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Michaela Fraser, MS, MPH 212-305-6722 email@example.com|
|Contact: Nancy Lee, MS 212-305-9416 firstname.lastname@example.org|
|Principal Investigator: Joel Stein, MD|
|Sub-Investigator: Matei Ciocarlie, PhD|
|Principal Investigator:||Joel Stein, MD||Columbia University|