Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04266158
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04266158
Study Brief:
Protocol Section:
NCT04266158