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

Primary Purpose

Paresis, Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Myoelectric UE Device-UE Orthosis-No Device
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paresis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

MyoPro 2 Motion-G-orthosis-None

Comfy Splint

No Splint

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2018
Last Updated
March 11, 2022
Sponsor
Ohio State University
Collaborators
Medical University of South Carolina, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04266158
Brief Title
FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses
Acronym
FAME
Official Title
Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor stoppage of recruitment
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
September 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
Collaborators
Medical University of South Carolina, Northwestern University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paresis, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MyoPro 2 Motion-G-orthosis-None
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Comfy Splint
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Splint
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Myoelectric UE Device-UE Orthosis-No Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
0 - See Description
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.
Time Frame
see description above

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses

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