MyHand: An Active Hand Orthosis for Stroke Patients

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03767894
• Collaborator: Wallace H. Coulter Foundation (Other), U.S. National Science Foundation (U.S. Fed)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: EMG Band; Device: Shoulder harness	N/A

Detailed Description

Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.
• Primary Purpose: Treatment
• Official Title: MyHand: An Active Hand Orthosis for Stroke Patients
• Actual Study Start Date: Nov 13, 2017
• Actual Primary Completion Date: Jun 27, 2019
• Actual Study Completion Date: Jun 27, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: MyHand orthosis Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an electromyography (EMG) band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.

Device: EMG Band; The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.; Device: Shoulder harness; The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.

Outcome Measures

Primary Outcome Measures

1. Score on Action Research Arm Test (ARAT) [Baseline; Post-test at Week 4]

   The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.

2. Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) [Baseline; Post-test at Week 4]

   The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance. Please note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device.

Secondary Outcome Measures

1. Score on Modified Ashworth Scale (MAS) [Baseline]

   The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity originally developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 (no increases in tone) to 4 (limb rigid in flexion/extension or abduction/adduction). Please note: MAS is officially scored on a 5-point scale that includes "1+" (full range: 0, 1, 1+, 2, 3, 4). However non-numeric scores are not allowable in the Outcome Measure Data Table. Therefore, the scores were transformed from a 0-4 scale (including 1+) to a 0-5 scale (excluding 1+). The reported medians for all but Finger Flexors were not impacted by the scale transformation. Finger Flexor median is reported as 2 in the Outcome Measure Data Table, but this can be understood as a true median of 1+ if using the original MAS scoring scale.

2. Score on Box and Blocks Test (BBT) [Baseline; Post-test at Week 4]

   The BBT measures unilateral gross manual dexterity using blocks and a 2-compartment box. At the start, there are 150 blocks in one compartment and the score represents the number of blocks transferred from one compartment to the other compartment in 60 seconds. Each hand is scored separately, however only scores for the impaired (hemiplegic) hand are reported. Scores can range from 0-150, with higher scores indicating better performance of manual dexterity.

3. Number of Participants Completing Treatment Protocol [4 Weeks]

   The number of participants who completed the full treatment protocol (12 training sessions).

4. Total Number of Adverse Events During Intervention [4 Weeks]

   All adverse events will be tracked during the course of the intervention. The Principal Investigator will review any event and assess it as either adverse or non-significant.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects over 18 years of age

• History of stroke resulting in significant upper limb impairment

• Full passive range of motion

• Gross control of the proximal upper extremity

• Lacks timely grasp/release

• No more than moderate flexor tone

• Intact cognition

Exclusion criteria include:

• Other Neurological/orthopedic disorders

• Excessive spasticity/contracture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• Wallace H. Coulter Foundation
• U.S. National Science Foundation

Investigators

• Principal Investigator: Joel Stein, MD, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 13, 2020

More Information

Publications

None provided.

• Responsible Party: Joel Stein, MD, Simon Baruch Professor of Physical Medicine and Rehabilitation, Columbia University
• ClinicalTrials.gov Identifier: NCT03767894
• Other Study ID Numbers: AAAP8752; IIS-1526960
• First Posted: Dec 7, 2018
• Last Update Posted: Nov 5, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Joel Stein, MD, Simon Baruch Professor of Physical Medicine and Rehabilitation, Columbia University: Hand orthosis; Stroke
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 72.7%
>=65 years	3 27.3%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	52
Sex: Female, Male (Count of Participants)
Female	5 45.5%
Male	6 54.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	11 100%
Type of Stroke (Count of Participants)
Ischemic Stroke	9 81.8%
Hemorragic Stroke	1 9.1%
Unknown Type (by participant)	1 9.1%

Outcome Measures

1. Primary Outcome

Title	Score on Action Research Arm Test (ARAT)
Description	The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.
Time Frame	Baseline; Post-test at Week 4

Outcome Measure Data

Analysis Population Description

Only the 11 subjects that completed the study were included in this analysis.

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Measure Participants	11
Baseline	13.46 (2.184)
Post Unassisted (week 4)	14.82 (2.148)
Post Assisted (week 4)	13.09 (1.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MyHand Orthosis
	Comments	Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).
	Type of Statistical Test	Other
	Comments	Descriptive analysis (paired sample t-test)
Statistical Test of Hypothesis	p-Value	0.24
	Comments	a priori threshold: p<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.
	Method	t-test, 2 sided
	Comments	Adjustment for p-value is 2.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.36
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MyHand Orthosis
	Comments	Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).
	Type of Statistical Test	Other
	Comments	Descriptive analysis (paired sample t-test)
Statistical Test of Hypothesis	p-Value	0.207
	Comments	a priori threshold: p<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.
	Method	t-test, 2 sided
	Comments	Adjustment for p-value is 2.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.72
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)
Description	The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance. Please note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device.
Time Frame	Baseline; Post-test at Week 4

Outcome Measure Data

Analysis Population Description

Only the 11 subjects that completed the study were included in this analysis.

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Measure Participants	11
Baseline	25.36 (1.521)
Post Unassisted (week 4)	28 (1.854)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MyHand Orthosis
	Comments	Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).
	Type of Statistical Test	Other
	Comments	Descriptive analysis (paired sample t-test)
Statistical Test of Hypothesis	p-Value	0.026
	Comments	a priori threshold: p<0.05
	Method	Paired sample T-test
	Comments	2-tailed
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.64
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Score on Modified Ashworth Scale (MAS)
Description	The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity originally developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 (no increases in tone) to 4 (limb rigid in flexion/extension or abduction/adduction). Please note: MAS is officially scored on a 5-point scale that includes "1+" (full range: 0, 1, 1+, 2, 3, 4). However non-numeric scores are not allowable in the Outcome Measure Data Table. Therefore, the scores were transformed from a 0-4 scale (including 1+) to a 0-5 scale (excluding 1+). The reported medians for all but Finger Flexors were not impacted by the scale transformation. Finger Flexor median is reported as 2 in the Outcome Measure Data Table, but this can be understood as a true median of 1+ if using the original MAS scoring scale.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Baseline scores on MAS. Only the 11 subjects that completed the study were included in this analysis.

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Measure Participants	11
Elbow Flexors (baseline)	1
Elbow Extensors (baseline)	1
Wrist Flexors (baseline)	1
Wrist Extensors (baseline)	0
Finger Flexors (baseline)	2
Finger Extensors (baseline)	0

4. Secondary Outcome

Title	Score on Box and Blocks Test (BBT)
Description	The BBT measures unilateral gross manual dexterity using blocks and a 2-compartment box. At the start, there are 150 blocks in one compartment and the score represents the number of blocks transferred from one compartment to the other compartment in 60 seconds. Each hand is scored separately, however only scores for the impaired (hemiplegic) hand are reported. Scores can range from 0-150, with higher scores indicating better performance of manual dexterity.
Time Frame	Baseline; Post-test at Week 4

Outcome Measure Data

Analysis Population Description

Only the 11 subjects that completed the study were included in this analysis.

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Measure Participants	11
Baseline	47 (2.289)
Post Unassisted (week 4)	35 (1.843)
Post Assisted (week 4)	24 (0.585)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MyHand Orthosis
	Comments	Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.
	Type of Statistical Test	Other
	Comments	Descriptive analysis (paired Wilcoxon)
Statistical Test of Hypothesis	p-Value	0.442
	Comments	a priori threshold: p<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.
	Method	Wilcoxon (Mann-Whitney)
	Comments	Adjustment for p-value is 2.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.09
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MyHand Orthosis
	Comments	Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).
	Type of Statistical Test	Other
	Comments	Descriptive analysis (paired Wilcoxon)
Statistical Test of Hypothesis	p-Value	1.0
	Comments	a priori threshold: p<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.
	Method	Wilcoxon (Mann-Whitney)
	Comments	Adjustment for p-value is 2.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Participants Completing Treatment Protocol
Description	The number of participants who completed the full treatment protocol (12 training sessions).
Time Frame	4 Weeks

Outcome Measure Data

Analysis Population Description

Number of participants who completed the treatment protocol (12 sessions). Only the 11 subjects that completed the study were included in this analysis.

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Measure Participants	11
Count of Participants [Participants]	11 100%

6. Secondary Outcome

Title	Total Number of Adverse Events During Intervention
Description	All adverse events will be tracked during the course of the intervention. The Principal Investigator will review any event and assess it as either adverse or non-significant.
Time Frame	4 Weeks

Outcome Measure Data

Analysis Population Description

Number of participants who experienced adverse events. Only the 11 subjects that completed the study were included in this analysis.

Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Measure Participants	11
Number [adverse events]	0

Adverse Events

Time Frame	Up to 4 weeks
Arm/Group Title	MyHand Orthosis
Arm/Group Description	Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight. EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis. Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
All Cause Mortality
	MyHand Orthosis
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	MyHand Orthosis
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	MyHand Orthosis
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.