FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses

NCT04266158 | Terminated Results FDA Device

• 1 other identifier: 2016H0339
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paresis; Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

MyoPro 2 Motion-G-orthosis-None

ACTIVE COMPARATOR

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

Comfy Splint

ACTIVE COMPARATOR

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

No Splint

ACTIVE COMPARATOR

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

Interventions

Myoelectric UE Device-UE Orthosis-No Device 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.

Comfy Splint; MyoPro 2 Motion-G-orthosis-None; No Splint

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Ohio State University: lead
• Medical University of South Carolina: collaborator
• Northwestern University: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Paresis; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: College of Medicine Office of Research Compliance Team
• Organization: The Ohio University

comresearchcompliance@osumc.edu

6145886811

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 12, 2020
• Study Start: October 1, 2017
• Primary Completion: September 18, 2018
• Study Completion: September 18, 2018
• Last Updated: April 11, 2022
• Results First Posted: April 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)