Portable EMG-triggered Hand Robot for Individuals After Stroke

• ClinicalTrials.gov Identifier: NCT02364700
• Recruitment Status: Completed
• First Posted: February 18, 2015
• Results First Posted: July 12, 2017
• Last Update Posted: July 12, 2017
• Sponsor: Rehab-Robotics Company Limited
• Collaborator: New York Presbyterian Hospital
• Information provided by (Responsible Party): Rehab-Robotics Company Limited

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: Hand of Hope (HOH)	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Hand Training Utilizing an Electromyography-triggered Hand Robot for Individuals After Chronic Stroke
• Study Start Date: March 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm

Intervention/treatment

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

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)

Outcome Measures

Primary Outcome Measures :

1. Fugl-Meyer Assessment of Upper Extremity (FMA) [ Time Frame: baseline to 6 weeks (discharge) ]
   The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.
2. Arm Motor Ability Test (AMAT) [ Time Frame: Baseline to 6 weeks (discharge) ]
   The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.
3. Box and Blocks [ Time Frame: Baseline to 6 weeks (discharge) ]
   The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.

Secondary Outcome Measures :

1. Stroke Upper Limb Capacity Scale (SULCS) [ Time Frame: Baseline to 6 weeks (discharge) ]
   The SULCs is a performance based measure of upper limb capacity after stroke. Each of the 10 items are administered in a hierarchical order and assigned a score of 0 (unable to complete) or 1 (able to complete the task) with a maximum score of 10.
2. Hand Dynamometry [ Time Frame: baseline to 6 weeks (discharge) ]
   A dynamometer measures grip strength in kilograms
3. Stroke Impact Scale --Hand Sub Scale (SIS-H) [ Time Frame: baseline to 6 weeks (discharge) ]

   The Stroke Impact Scale is a stroke-specific questionnaire evaluating quality of life in stroke survivors over eight domains. Each domain is scored independently on an ordinal scale ranging from 0 (minimum) bto a maximum of 5. Only the Hand sub-score was used in this study. Scores for each domain are transformed and range from 0-100.

   Formula for scoring domains:

   Transformed Scale = [(Actual raw score - lowest possible raw score) / Possible raw score] * 100

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

NewYork Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, United States, 10065

Sponsors and Collaborators

Rehab-Robotics Company Limited

New York Presbyterian Hospital

More Information

Publications of Results:

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.

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.

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.

Other Publications:

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.

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.

• Responsible Party: Rehab-Robotics Company Limited
• ClinicalTrials.gov Identifier: NCT02364700
• Other Study ID Numbers: 1409015458
• First Posted: February 18, 2015
• Results First Posted: July 12, 2017
• Last Update Posted: July 12, 2017
• Last Verified: June 2017

Keywords provided by Rehab-Robotics Company Limited:

stroke, robotics, hand rehabilitation

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases