FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses (FAME)

Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis

The primary study objective is to compare post-stroke upper extremity (UE) movement while wearing a brace called the MyoPro 2 Motion G versus UE movement while wearing a resting splint and no device in stroke survivors with moderate UE dysfunction. During the study, subjects will undergo general training in the operation of the EMG-controlled orthosis and the comparison orthosis, and then guided through a series of standard clinical outcome measures. These outcome measures will allow the researchers to directly compare the relative benefit of the MyoPro 2 Motion G with a resting hand splint and no device in reducing UE impairment and increasing UE dexterity and functional task performance.

Study Overview

• Status: Terminated
• Conditions: Stroke; Paresis
• Intervention / Treatment: Device: Myoelectric UE Device-UE Orthosis-No Device

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Manual Muscle Test >1/5 in the paretic biceps, triceps, finger extensors and finger flexors;
• score > 10 < 30 on the Upper extremity Fugl Meyer AND active shoulder flexion of at least 30 degrees with device weight on affected arm;
• Ability to generate consistent, detectable EMG signal from the bicep/tricep upper arm and distal forearm flexor and extensor sensor sites with wrist in neutral, and fingers in neutral. At rest, achieve an EMG of 5 or below on myConfig (wrist and fingers in neutral and elbow extended); with gain at < 10 and boost <12, able to reach a threshold of 10 at both bicep and wrist flexors/extensors;
• a single stroke that is the cause of arm impairment, experienced >12 months ago; if there are additional asymptomatic lesions (as diagnosed by MRI), these subjects may also be included. Those with another symptomatic stroke in addition to the stroke causing arm impairment are excluded;
• score >70 on the Modified Mini Mental Status Examination;
• age >18< 85;
• > 6 months since previous functional or therapeutic use of an upper extremity myoelectric orthosis;
• Height >5'0";
• Weight >110< 250 lbs.;
• Forearm circumference (at widest part) <13 in.;
• Bicep circumference >9 <15 in.;
• Upper arm length >5.5 in.;
• Wrist thickness (anterior- posterior) <1.75 in.;
• ability to stand with minimal assistance

Exclusion Criteria:

• > 5 on a 0-10 Numeric Pain Rating Scale for pain in the paretic hand, arm or shoulder;
• > 3 on the Modified Ashworth Spasticity Scale in the paretic elbow, >2 at wrist or fingers;
• < 2.5 on the Alexander Apraxia scale; '
• history of neurological disorder other than stroke;
• change in anti-spasticity medications in the last 6 months, and/or receipt of botulinum toxin in the paretic UE in the previous 4 months;
• elbow contracture greater than 10 degrees;
• inability to passively extend fingers while wrist is in neutral;
• other conditions or physical/mental attributes that may undermine safety and/or full participation in the study;
• bilateral hemiparesis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MyoPro 2 Motion-G-orthosis-None; Following screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized.	Device: Myoelectric UE Device-UE Orthosis-No Device; all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects.
Active Comparator: Comfy Splint; Following screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized.	Device: Myoelectric UE Device-UE Orthosis-No Device; all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects.
Active Comparator: No Splint; Following screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized.	Device: Myoelectric UE Device-UE Orthosis-No Device; all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
0 - See Description	The PI is no longer at The Ohio State University and is not actively working at another institution for record transfer. We contacted remaining study team members and department chair to obtain updates for these records. We were told the PI was dismissed and there was alleged noncompliance and misconduct. The study team and department chair are unable to confirm if available documents for these records are accurate.	see description above

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Medical University of South Carolina; Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): September 18, 2018
• Study Completion (Actual): September 18, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 2016H0339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No