Portable EMG-triggered Hand Robot for Individuals After Stroke

• Sponsor: Rehab-Robotics Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02364700
• Collaborator: New York Presbyterian Hospital (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 0.8

Study Details

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)	N/A

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
• 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: Mar 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 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) [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) [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 [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) [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 [baseline to 6 weeks (discharge)]

   A dynamometer measures grip strength in kilograms

3. Stroke Impact Scale --Hand Sub Scale (SIS-H) [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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: Feb 18, 2015
• Last Update Posted: Jul 12, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Rehab-Robotics Company Limited: stroke, robotics, hand rehabilitation
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (10.2)
Sex: Female, Male (Count of Participants)
Female	10 83.3%
Male	2 16.7%
Box and Blocks (number of blocks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of blocks]	5.67 (10.36)
Arm Motor Ability Test (AMAT) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.13 (.50)
Fugl-Meyer Assessment (FMA) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.75 (7.90)
Stroke Upper Limb Capacity Scale (SULCS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.33 (2.15)
Stroke Impact Scale-Hand Subscale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.50 (4.91)
Dynamometry (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	7.96 (6.24)

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	22.50 (9.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interventional Group
	Comments
	Type of Statistical Test	Equivalence
	Comments	Group means from baseline to discharge were compared to determine if 6-week and training on the Hand of Hope device elicited changes in outcome measures.
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	Friedman Test
	Comments

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	2.35 (0.58)

3. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
Measure Participants	12
Mean (Standard Deviation) [totally number of blocks transferred]	6.08 (10)

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	5.17 (2.17)

5. Secondary Outcome

Title	Hand Dynamometry
Description	A dynamometer measures grip strength in kilograms
Time Frame	baseline to 6 weeks (discharge)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
Measure Participants	12
Mean (Standard Deviation) [kilograms]	8.23 (6.18)

6. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	13.33 (5.48)

Adverse Events

Arm/Group Title	Interventional Group
Arm/Group Description	This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks
All Cause Mortality
	Interventional Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Interventional Group
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Interventional Group
	Affected / at Risk (%)	# Events
Total	7/12 (58.3%)
General disorders
fatigue (cognitive)	3/12 (25%)	3
Musculoskeletal and connective tissue disorders
shoulder fatigue	6/12 (50%)	6
Skin and subcutaneous tissue disorders
mild skin rubbing	7/12 (58.3%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.