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MyHand: An Active Hand Orthosis for Stroke Patients

NCT ID: NCT03767894

Last Updated: 2020-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2019-06-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.

Study Groups

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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.

Group Type EXPERIMENTAL

EMG Band

Intervention Type 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.

Shoulder harness

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

* Other Neurological/orthopedic disorders
* Excessive spasticity/contracture
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wallace H. Coulter Foundation

OTHER

Sponsor Role collaborator

U.S. National Science Foundation

FED

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Joel Stein, MD

Simon Baruch Professor of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IIS-1526960

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAP8752

Identifier Type: -

Identifier Source: org_study_id