MyHand: An Active Hand Orthosis for Stroke Patients

NCT03767894 | Completed Results FDA Device

• 2 other identifiers: AAAP8752IIS-1526960
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Hand orthosis; Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Score on Modified Ashworth Scale (MAS)

  Baseline

• Score on Box and Blocks Test (BBT)

  Baseline; Post-test at Week 4

• Number of Participants Completing Treatment Protocol

  4 Weeks

• Total Number of Adverse Events During Intervention

  4 Weeks

Study Arms (1)

MyHand orthosis

EXPERIMENTAL

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; Device: Shoulder harness

Interventions

EMG Band DEVICE

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.

MyHand orthosis

Shoulder harness DEVICE

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.

MyHand orthosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other Neurological/orthopedic disorders
• Excessive spasticity/contracture

Sponsors & Collaborators

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

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Joel Stein
• Organization: Columbia University

js1165@columbia.edu

(212) 305-4818

Study Officials

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simon Baruch Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: December 7, 2018
• Study Start: November 13, 2017
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: November 5, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)