Portable EMG-triggered Hand Robot for Individuals After Stroke

NCT ID: NCT02364700

Last Updated: 2017-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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interventional group

This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device.

Group Type EXPERIMENTAL

Hand of Hope (HOH)

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role collaborator

Rehab-Robotics Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NewYork Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18928333 (View on PubMed)

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. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3406-9. doi: 10.1109/IEMBS.2010.5627930.

Reference Type BACKGROUND
PMID: 21097247 (View on PubMed)

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/ICORR.2011.5975340.

Reference Type RESULT
PMID: 22275545 (View on PubMed)

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.

Reference Type RESULT
PMID: 23932795 (View on PubMed)

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. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

Reference Type RESULT
PMID: 12907818 (View on PubMed)

Other Identifiers

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1409015458

Identifier Type: -

Identifier Source: org_study_id

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