Portable EMG-triggered Hand Robot for Individuals After Stroke

Stroke Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02364700
• Other study ID #: 1409015458
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2015
• Last updated: November 2, 2015
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: November 2015
• Source: Rehab-Robotics Company Limited
• Contact: Grace J Kim, MS,OTR/L
• Phone: 212-746-1356
• Email: grk9006[@]nyp.org
• Is FDA regulated: No
• Health authority: United States:Weill Cornell Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is an interventional pilot study investigating the feasibility of using the hand of hope (HOH) device for individuals with decreased hand function after stroke.

Description:

The HOH will be used to provide hand training for patients with decreased hand ability after stroke. The HOH is a light-weight, non-invasive, portable hand robot that provides physical assistance when a patient activates the muscles that open and close the hand. The HOH works by detecting surface EMG muscle activity and therefore requires active participation from the patient throughout the session. Video games linked to the HOH device are specifically designed to work on opening and closing the hand facilitating mass practice and high repetition needed for improving strength and range of motion of muscles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of stroke > 6 months ago

2. Presence of some active range of motion (AROM) in the affected hand, measured by a score of at least 1 on the Box and Block test.

3. Intact sensation in the affected hand

4. Full passive range of motion (PROM) in mass flexion and extension of the hand

5. MAS score < 3 for finger flexors and intrinsics

6. MAS score < 3 for finger extensors

7. Visual tracking is intact in all directions

8. Patient must be otherwise medically stable in the opinion of the principal investigator

Exclusion Criteria:

1. Patient is receiving active occupational or physical therapy for the affected arm

2. Patient has joint contractures that prevent proper fit into the HOH device

3. Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis

4. It has been less than 3 months since last botulinum toxin injection in the affected arm

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Hand of Hope (HOH)
Subjects will receive arm training 3x/week for 6 weeks, each session is anticipated to last approximately 60 minutes. Sessions will be scheduled for Monday, Wednesday, and Friday whenever possible to provide a rest period between sessions. Each session will consist of the following: warm up-passive stretch of hand in flexion and extension (5 minutes); setting the EMG threshold parameters for the device; active practicing of opening the hand (Desperate Bee, Hungry Bird, Sun Archer games; 10 min) active practice of closing then hand (UFO Catcher game; 10 min) open and closing the hand (Ball and Basket game; 10 min) open and closing the hand while incorporating reach ( for subjects with adequate ability to reach with shoulder/elbow; 10 min) cool down-passive stretch of hand in flexion and extension (5 minutes)

Locations

Country	Name	City	State
United States	NewYork Presbyterian Hospital-Weill Cornell Medical Center	New York City	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rehab-Robotics Company Limited	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Ho NS, Tong KY, Hu XL, Fung KL, Wei XJ, Rong W, Susanto EA. An EMG-driven exoskeleton hand robotic training device on chronic stroke subjects: task training system for stroke rehabilitation. IEEE Int Conf Rehabil Robot. 2011;2011:5975340. doi: 10.1109/ICO — View Citation

Hu XL, Tong KY, Wei XJ, Rong W, Susanto EA, Ho SK. The effects of post-stroke upper-limb training with an electromyography (EMG)-driven hand robot. J Electromyogr Kinesiol. 2013 Oct;23(5):1065-74. doi: 10.1016/j.jelekin.2013.07.007. Epub 2013 Aug 7. — View Citation

Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. Epub 2003 Aug 7. — View Citation

O'Dell MW, Lin CC, Harrison V. Stroke rehabilitation: strategies to enhance motor recovery. Annu Rev Med. 2009;60:55-68. doi: 10.1146/annurev.med.60.042707.104248. Review. — View Citation

Tong KY, Ho SK, Pang PK, Hu XL, Tam WK, Fung KL, Wei XJ, Chen PN, Chen M. An intention driven hand functions task training robotic system. Conf Proc IEEE Eng Med Biol Soc. 2010;2010:3406-9. doi: 10.1109/IEMBS.2010.5627930. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment of Upper Extremity	performance based evaluation of upper limb impairment of the affected arm after stroke.	Changes of Fugl-Meyer Assessment of Upper Extremity at discharge and 6-week follow up	No
Primary	Arm Motor Ability Test (AMAT)	performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks.	Changes of AMAT at discharge and 6-week follow up	No
Primary	Box and Blocks	functional assessment of general hand ability looking at gross grasp and release of the hand.	Changes of Box and Blocks at discharge and 6-week follow up	No
Secondary	Stroke Upper Limb Capacity Scale (SULCS)	performance based measure of proximal arm impairment and distal hand function	Changes of SULCS at discharge and 6-week follow up	No
Secondary	Hand Dynamometry	measure of grip strength measured in pounds.	Changes of Hand Dynamometry at discharge and 6-week follow up	No
Secondary	Stroke Impact Scale (SIS)	questionnaire completed by participants consisting of items related to mobility, memory, mood, communication, activities of daily living, hand function, and life roles.	Changes of SIS at discharge and 6-week follow up	No