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Portable EMG-triggered Hand Robot for Individuals After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand of Hope (HOH)
Sponsored by
Rehab-Robotics Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring stroke, robotics, hand rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NewYork Presbyterian Hospital-Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

interventional group

Arm Description

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

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment of Upper Extremity (FMA)
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.
Arm Motor Ability Test (AMAT)
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.
Box and Blocks
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

Stroke Upper Limb Capacity Scale (SULCS)
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.
Hand Dynamometry
A dynamometer measures grip strength in kilograms
Stroke Impact Scale --Hand Sub Scale (SIS-H)
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

Full Information

First Posted
February 5, 2015
Last Updated
June 13, 2017
Sponsor
Rehab-Robotics Company Limited
Collaborators
New York Presbyterian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02364700
Brief Title
Portable EMG-triggered Hand Robot for Individuals After Stroke
Official Title
Hand Training Utilizing an Electromyography-triggered Hand Robot for Individuals After Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rehab-Robotics Company Limited
Collaborators
New York Presbyterian Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, robotics, hand rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interventional group
Arm Type
Experimental
Arm Description
This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device.
Intervention Type
Device
Intervention Name(s)
Hand of Hope (HOH)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity (FMA)
Description
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.
Time Frame
baseline to 6 weeks (discharge)
Title
Arm Motor Ability Test (AMAT)
Description
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.
Time Frame
Baseline to 6 weeks (discharge)
Title
Box and Blocks
Description
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.
Time Frame
Baseline to 6 weeks (discharge)
Secondary Outcome Measure Information:
Title
Stroke Upper Limb Capacity Scale (SULCS)
Description
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.
Time Frame
Baseline to 6 weeks (discharge)
Title
Hand Dynamometry
Description
A dynamometer measures grip strength in kilograms
Time Frame
baseline to 6 weeks (discharge)
Title
Stroke Impact Scale --Hand Sub Scale (SIS-H)
Description
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
Time Frame
baseline to 6 weeks (discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of stroke > 6 months ago 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. Intact sensation in the affected hand Full passive range of motion (PROM) in mass flexion and extension of the hand MAS score < 3 for finger flexors and intrinsics MAS score < 3 for finger extensors Visual tracking is intact in all directions Patient must be otherwise medically stable in the opinion of the principal investigator Exclusion Criteria: Patient is receiving active occupational or physical therapy for the affected arm Patient has joint contractures that prevent proper fit into the HOH device Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis It has been less than 3 months since last botulinum toxin injection in the affected arm
Facility Information:
Facility Name
NewYork Presbyterian Hospital-Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18928333
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.
Results Reference
background
PubMed Identifier
21097247
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. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3406-9. doi: 10.1109/IEMBS.2010.5627930.
Results Reference
background
PubMed Identifier
22275545
Citation
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.
Results Reference
result
PubMed Identifier
23932795
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.
Results Reference
result
PubMed Identifier
12907818
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. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
Results Reference
result

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Portable EMG-triggered Hand Robot for Individuals After Stroke

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