Clinical trial NCT05036642: Effects of Post-Stroke Upper Extremity Assistance
Official title: Effects of Post-Stroke Upper Extremity Assistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arm Weakness as a Consequence of Stroke
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to quantify the improvement of post- stroke individuals' ability to move their arms during and after robot assisted therapy.

While researchers know that robot assisted therapies improve motor performance over the course of weeks, they do not know how motor performance is affected over the course of minutes or hours. A better understanding of how robot assisted therapies affect motor performance on short time scales may help us to prescribe more effective therapy doses to maximize motor recovery after neurological injury.

The study will allow us to obtain a detailed understanding of the performance of the device as described above.


Eligibility criteria: Inclusion Criteria:

* greater than 6 months post-stroke
* passive abduction to 90 degrees at shoulder
* reduced active (retro)flexion/extension at shoulder when abducted at 90 degrees
* reduced active flexion/extension at elbow

Exclusion Criteria:

* unable to give informed consent
* unable to comprehend and follow instructions
* have a condition (other than stroke) affecting sensorimotor function
* show evidence of unilateral spatial neglect
* unable to sit in a chair without armrests for 2 hours

Primary outcomes:
measure: Wolf Motor Function Test - Change in Functional Score by Task (WMFT)
timeFrame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
measure: Wolf Motor Function Test - Change in Completion Time by Task
timeFrame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
measure: Wolf Motor Function Test - Weight Lifted
timeFrame: Assessed at baseline (without the device) and after approximately 5 minutes of use with the device.
measure: Percentage of Successful Motions
timeFrame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
measure: Reachable Workspace - Mean Distance From Trunk, Successful Motions
timeFrame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
measure: Reachable Workspace - Area, Successful Motions
timeFrame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
measure: Reachable Workspace - Mean Distance From Trunk, All Motions
timeFrame: Assessed at baseline (without the device) and after approximately 60 minutes of use with the device.
Secondary outcomes:
measure: Participant Satisfaction Survey
timeFrame: After study procedures have been performed, on day 2 (up to 5 minutes to complete survey)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University CHARM Lab
state: California
Study officials:
affiliation: Stanford University
name: Allison Okamura
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sukal TM, Ellis MD, Dewald JP. Shoulder abduction-induced reductions in reaching work area following hemiparetic stroke: neuroscientific implications. Exp Brain Res. 2007 Nov;183(2):215-23. doi: 10.1007/s00221-007-1029-6. Epub 2007 Jul 20.