Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

NCT ID: NCT02544672

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).

Detailed Description

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The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.

Conditions

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Cerebrovascular Accidents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Myoelectric Elbow-Wrist-Hand Orthosis

Group Type EXPERIMENTAL

Myoelectric Elbow-Wrist-Hand orthosis

Intervention Type DEVICE

An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.

Interventions

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Myoelectric Elbow-Wrist-Hand orthosis

An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.

Intervention Type DEVICE

Other Intervention Names

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MyoPro®

Eligibility Criteria

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Inclusion Criteria

* Adults over 18 years.
* Upper limb impairment caused by any stroke (CVA)
* Minimum of trace MMT (1/5) in Biceps and/or Triceps
* Full Passive range of motion in elbow, forearm, wrist, and hand
* Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
* Score of at least 20 on the Mini Mental Status Examination.
* Ability to read and comprehend the English language.
* Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.

Exclusion Criteria

* Fixed upper limb contractures on affected side.
* Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
* Inability to follow three step directions.
* Severe shoulder subluxation, pain or shoulder dislocation.
* Passive shoulder range of motion less than 45 degrees in flexion and abduction.
* Pain or hypersensitivity in the arm(s)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myomo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GRE Chardon

Chardon, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan Naft, CPO, LPO

Role: CONTACT

440-285-5785

Facility Contacts

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Jonathan Naft, CPO, LPO

Role: primary

440-285-5785

Other Identifiers

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15-260

Identifier Type: -

Identifier Source: org_study_id

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