MyHand: An Active Hand Orthosis for Stroke Patients

Stroke Clinical Trial

Official title:

MyHand: An Active Hand Orthosis for Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767894
• Other study ID #: AAAP8752
• Secondary ID: IIS-1526960
• Status: Completed
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: June 27, 2019

Study information

• Verified date: October 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	U.S. National Science Foundation, Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Action Research Arm Test (ARAT)	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.	Baseline; Post-test at Week 4
Primary	Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)	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.	Baseline; Post-test at Week 4
Secondary	Score on Modified Ashworth Scale (MAS)	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.	Baseline
Secondary	Score on Box and Blocks Test (BBT)	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.	Baseline; Post-test at Week 4
Secondary	Number of Participants Completing Treatment Protocol	The number of participants who completed the full treatment protocol (12 training sessions).	4 Weeks
Secondary	Total Number of Adverse Events During Intervention	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.	4 Weeks