FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses

NCT ID: NCT04266158

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-09-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Myoelectric UE Device-UE Orthosis-No Device

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Myoelectric UE Device-UE Orthosis-No Device

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Myoelectric UE Device-UE Orthosis-No Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2016H0339

Identifier Type: -

Identifier Source: org_study_id