MyHand: An Active Hand Orthosis for Stroke Patients
Phase: NA
Conditions: Stroke
Sponsor: Columbia University

 
 
 
 
 
 
 
 
 
 
 
NCT03767894 
 
 
 
 
 
 
 
 
 
Official Title: MyHand: An Active Hand Orthosis for Stroke Patients 
Version Date: 4/13/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Scientific Background: 
Stroke is the most common neurological disorder in the U.S. (Roger, et al., 2012). 15-30% of stroke 
survivors are permanently disabled and 20% require institutional care (Mackay & Mensah, 2004). Upper 
extremity hemiparesis is one of the most common consequences of stroke and a major cause of 
disability and decreased quality of life in stroke survivors (Roger, et al., 2012). Existing rehabilitation 
techniques are frequently ineffective in restoring a sufficient amount of hand function in the affected 
limb to enable independent completion of daily tasks. Robotic therapies have been developed as an 
exercise tool for stroke survivors to utilize as an adjunct to conventional therapy. Therapeutic robots 
have the potential to deliver high-intensity task specific training, that may make them beneficial for 
stroke survivors with upper extremity hemiparesis (Chang and Kim, 2013). There are a variety of robotic 
devices that have been developed for upper limb rehabilitation after stroke, ranging from large 
workstations to lightweight wearable devices with a variety of control strategies. Most of these devices 
have focused on the shoulder, elbow or wrist, with relatively few focused on hand rehabilitation. 
MyHand is a unique device prototype that was developed in a collaborative project between faculty in 
the Columbia University Departments of Mechanical Engineering and Rehabilitation and Regenerative 
Medicine. MyHand is a noninvasive device that is worn on the forearm and hand.  It contains motors 
and “exotendons” that physically assist with finger movements. The device can be controlled by surface 
EMG signals from the ipsilateral forearm or by a contralateral shoulder harness.   
References:  
Chang, W. H. & Kim, Y. (2013). Robotic-assisted therapy in stroke rehabilitation. Stroke, 15(3). doi: 
10.5853/jos.2013.15.3.174 
Mackay, J & Mensah, G. A. (2004). The atlas of heart disease and stroke. Geneva, CH: World Health 
Organization. 
Roger, et al., (2012). Heart disease and stroke statistics--2012 update: A report from the American Heart 
Association. Circulation, 125(1). doi: 10.1161/CIR.0b013e31823ac046 
 
Study Objectives: 
Primary Research Question: Is the MyHand prototype effective at assisting stroke survivors to complete 
functional tasks with their upper extremity following a training period of 4 weeks?  
Hypothesis 1: (Primary) We anticipate that there will be an improvement in functional use of the 
impaired upper extremity after training with MyHand.  
Hypothesis 2 (Secondary): We anticipate that training with MyHand will improve strength and/or 
coordination in the impaired upper extremity as demonstrated by improvements in impairment based 
outcome measures. 
 
Study Design and Methods:  
This is designed as a non-randomized interventional study of the effects of a 4-week training protocol 
with the MyHand device on functional and impairment based measures of upper extremity performance 
in stroke survivors with hemiparesis. Up to 24 community-dwelling chronic stroke survivors will be 

recruited to participate in this study. Participants will complete the informed written consent process 
followed by screening procedures according to the following criteria.   
Inclusion Criteria: 
• 
Stroke diagnosis at least 6 months prior to start of study 
• 
Passive range of motion: Wrist to neutral, Digits within normal limits 
• 
Moderate muscle tone, i.e., Modified Ashworth Scale (MAS)≤2 in digits, wrist, and elbow 
• 
Active Range of Motion: At least 30 degrees shoulder flexion, 20 degrees shoulder abduction, 20 
degrees elbow flexion, finger flexion within functional limits 
• 
Strength: At least trace palpable finger extension 
• 
Able to successfully flex the fingers to form a grasp 
• 
Unable to extend the fingers fully without assistance 
• 
Intact cognition to provide informed written consent 
Exclusion criteria were: 
• 
Concurrent participation in another study 
• 
Comorbid orthopedic condition/pain limiting functional use of the impaired upper extremity 
• 
History or neurological disorder other than stroke 
• 
Excessive spasticity (Greater than 2 on the MAS) 
• 
Recent Botox injection to the affected limb (< 13 weeks) 
Participants will be assessed at baseline and after completing the 4-week training protocol with the 
following outcome measures: Fugl-Meyer Upper Extremity Scale (UEFM), the Action Research Arm Test 
(ARAT), the Box and Blocks Test (BBT), the Modified Ashworth Scale (MAS). For baseline measurements, 
all outcome measures will be performed without the assistance of the device. To evaluate rehabilitative 
and assistive effects of the training protocol, participants will complete post-testing assessments under 
two conditions over the course of two sessions to avoid fatigue. One session of post-testing will involve 
administration of the UEFM, ARAT, and BBT without robotic-assistance (unassisted condition), while the 
other session will involve administration of the ARAT and BBT with robotic assistance (assisted 
condition). The UEFM will only be performed at post-testing in the unassisted condition because the 
UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping 
and pinching tasks. We thus presume that robotic assistance will have minimal influence on FM scores. 
All outcome measures will be administered by an occupational therapist who is not involved in the 
training program.  
Next, participants will be fitted with the MyHand device and screened with the EMG classifier to 
determine if they will use the EMG or shoulder harness control method. During the control screening, a 
classifier algorithm will by trained with the subject’s EMG signals from the involved forearm. A 
participant will be assigned to the EMG control if they pass the classifier or the shoulder harness if they 
fail. Each participant will be trained to use their assigned control method.  
The training protocol involves 12 sessions (3 sessions per week for 4 weeks). Each session will involve 30 
minutes of active training time in which participants will practice a variety of grasp and release tasks 
with everyday objects to simulate Activities of Daily Living according to a standardized protocol. 
Participants who require additional upper extremity support to aid use of the device may be fitted with 
the commercially-available Saebo Mobile Arm Support to unweight the arm during training. Each 
training session will be supervised by a trained occupational or physical therapist. At the completion of 

the training protocol, participants’ upper extremity function will be reassessed with the outcome 
measures to evaluate if the MyHand device may have utility as rehabilitative and/or assistive device. 
 
IRB-Approved Protocol Amendments Since 11/14/18 
• 
12/10/18 Modification: Study personnel change due to staff turnover  
• 
9/19/19 Modification: Study personnel change due to addition of new PhD-student 
 
 
Statistical Analysis Plan   
We tested all the clinical outcome data and gains for normal distribution based on the residuals of our 
dependent variables with Shapiro-Wilk and visually with Q-Q plots. We also tested the homogeneity of 
variance using the Levene test. UEFM and ARAT passed normality and homogeneity test, and thus we 
applied paired sample t-tests. BBT failed the normality test. Therefore, we applied a nonparametric 
paired sample Wilcoxon test. Statistical significance was determined at p < 0.05.