Clinical trial NCT04266158: FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses
Official title: Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paresis
Stroke
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Northwestern University
First posted: 2020-02-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 0 - See Description
timeFrame: see description above
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: