Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
1 other identifier
interventional
30
1 country
1
Brief Summary
The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedSeptember 9, 2015
September 1, 2015
1 year
September 1, 2015
September 4, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Assessment of sensorimotor function for the upper extremities (arms) http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908
2 hours
Modified Ashworth Scale
Measurement of muscle spasticity due to nervous system injury or disease http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902
2 hours
Box and Blocks Test
An assessment of unilateral gross manual dexterity, measured by the number 1 inch cubes an individual can move over a barrier in a 60 second time period. http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=917
2 hours
Study Arms (1)
Myoelectric Elbow-Wrist-Hand Orthosis
EXPERIMENTALInterventions
An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.
Eligibility Criteria
You may qualify if:
- Adults over 18 years.
- Upper limb impairment caused by any stroke (CVA)
- Minimum of trace MMT (1/5) in Biceps and/or Triceps
- Full Passive range of motion in elbow, forearm, wrist, and hand
- Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
- Score of at least 20 on the Mini Mental Status Examination.
- Ability to read and comprehend the English language.
- Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.
You may not qualify if:
- Fixed upper limb contractures on affected side.
- Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
- Inability to follow three step directions.
- Severe shoulder subluxation, pain or shoulder dislocation.
- Passive shoulder range of motion less than 45 degrees in flexion and abduction.
- Pain or hypersensitivity in the arm(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Myomolead
Study Sites (1)
GRE Chardon
Chardon, Ohio, 44024, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2015
First Posted
September 9, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Last Updated
September 9, 2015
Record last verified: 2015-09