Trial Outcomes & Findings for MyHand: An Active Hand Orthosis for Stroke Patients (NCT NCT03767894)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline; Post-test at Week 4

Results posted on

2020-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	MyHand Orthosis 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 Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MyHand Orthosis 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 Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MyHand Orthosis n=11 Participants 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.
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=11 Participants
Age, Categorical >=65 years	3 Participants n=11 Participants
Age, Continuous	52 years n=11 Participants
Sex: Female, Male Female	5 Participants n=11 Participants
Sex: Female, Male Male	6 Participants n=11 Participants
Region of Enrollment United States	11 Participants n=11 Participants
Type of Stroke Ischemic Stroke	9 Participants n=11 Participants
Type of Stroke Hemorragic Stroke	1 Participants n=11 Participants
Type of Stroke Unknown Type (by participant)	1 Participants n=11 Participants

PRIMARY outcome

Timeframe: Baseline; Post-test at Week 4

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

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.

Outcome measures

Outcome measures
Measure	MyHand Orthosis n=11 Participants 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.
Score on Action Research Arm Test (ARAT) Baseline	13.46 score on a scale Standard Error 2.184
Score on Action Research Arm Test (ARAT) Post Unassisted (week 4)	14.82 score on a scale Standard Error 2.148
Score on Action Research Arm Test (ARAT) Post Assisted (week 4)	13.09 score on a scale Standard Error 1.43

PRIMARY outcome

Timeframe: Baseline; Post-test at Week 4

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

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.

Outcome measures

Outcome measures
Measure	MyHand Orthosis n=11 Participants 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.
Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) Baseline	25.36 score on a scale Standard Error 1.521
Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) Post Unassisted (week 4)	28 score on a scale Standard Error 1.854

SECONDARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Outcome measures
Measure	MyHand Orthosis n=11 Participants 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.
Score on Modified Ashworth Scale (MAS) Elbow Flexors (baseline)	1 score on a scale Interval 0.0 to 5.0
Score on Modified Ashworth Scale (MAS) Elbow Extensors (baseline)	1 score on a scale Interval 0.0 to 5.0
Score on Modified Ashworth Scale (MAS) Wrist Flexors (baseline)	1 score on a scale Interval 0.0 to 5.0
Score on Modified Ashworth Scale (MAS) Wrist Extensors (baseline)	0 score on a scale Interval 0.0 to 5.0
Score on Modified Ashworth Scale (MAS) Finger Flexors (baseline)	2 score on a scale Interval 0.0 to 5.0
Score on Modified Ashworth Scale (MAS) Finger Extensors (baseline)	0 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Baseline; Post-test at Week 4

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

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.

Outcome measures

Outcome measures
Measure	MyHand Orthosis n=11 Participants 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.
Score on Box and Blocks Test (BBT) Baseline	47 Blocks Standard Error 2.289
Score on Box and Blocks Test (BBT) Post Unassisted (week 4)	35 Blocks Standard Error 1.843
Score on Box and Blocks Test (BBT) Post Assisted (week 4)	24 Blocks Standard Error 0.585

SECONDARY outcome

Timeframe: 4 Weeks

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

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

Outcome measures

Outcome measures
Measure	MyHand Orthosis n=11 Participants 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.
Number of Participants Completing Treatment Protocol	11 Participants

SECONDARY outcome

Timeframe: 4 Weeks

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

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.

Outcome measures

Outcome measures
Measure	MyHand Orthosis n=11 Participants 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.
Total Number of Adverse Events During Intervention	0 adverse events

Adverse Events

MyHand Orthosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joel Stein

Columbia University

Phone: (212) 305-4818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place