Effects of Post-Stroke Upper Extremity Assistance

Arm Weakness as a Consequence of Stroke Clinical Trial

Official title:

Effects of Post-Stroke Upper Extremity Assistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036642
• Other study ID #: IRB-61540
• Secondary ID: SNI-BI1-02
• Status: Completed
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: September 7, 2022

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arm Weakness as a Consequence of Stroke
• Stroke

Intervention

Device:
• Compliant Passive Arm Support
The device is a mechanical device that consists of two linkages, elastic bands, a commercial posture brace, and a hook-and-loop fastener. The design of the device, with several compliant elements, ensures that one device fits many without joint alignment concerns. No motors or other actuators add energy into the system, meaning that it is stable.

Locations

Country	Name	City	State
United States	Stanford University CHARM Lab	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wolf Motor Function Test - Change in Functional Score by Task (WMFT)	Change reported as number of tasks where participants on average had increased functionality, no change, or decreased functionality. Lower functional scores are indicative of lower functional levels. The WMFT consists of 17 tasks: Forearm to table (side), Forearm to box (side), Extend elbow (to the side), Extend elbow (to the side) - with weight, Hand to table (front), Hand to box (front), Weight to box, Reach and retrieve, Lift can, Lift pencil, Lift paper clip, Stack checkers, Flip cards, Grip Strength, Turning key In lock, Fold towel, and Lift basket. Fifteen tasks were assessed for this outcome: task 7 (Weight to box) is reported in a separate analysis; task 14 (Grip strength) was excluded due to an inability to acquire the necessary equipment.	Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Primary	Wolf Motor Function Test - Change in Completion Time by Task	Change reported as number of tasks which participants on average performed with increased time, no change, or decreased time. If a participant was unable to complete the task, a time score of 120+ seconds was assigned and converted to 121 for calculation purposes. The WMFT consists of 17 tasks: Forearm to table (side), Forearm to box (side), Extend elbow (to the side), Extend elbow (to the side) - with weight, Hand to table (front), Hand to box (front), Weight to box, Reach and retrieve, Lift can, Lift pencil, Lift paper clip, Stack checkers, Flip cards, Grip Strength, Turning key In lock, Fold towel, and Lift basket. Fifteen tasks were assessed for this outcome: task 7 (Weight to box) is reported in a separate analysis; task 14 (Grip strength) was excluded due to an inability to acquire the necessary equipment.	Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Primary	Wolf Motor Function Test - Weight Lifted	Weight lifted (carried) in task 7 of the WMFT: Weight to box. In this assessment, the participant is seated and lifts weight to a box centered on a table in front of them, while keeping his/her back against the chair.	Assessed at baseline (without the device) and after approximately 5 minutes of use with the device.
Primary	Percentage of Successful Motions	Participants are instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. The participant was asked to perform 6 motions (3 clockwise and 3 counterclockwise in randomized order). This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. Successful motion is defined as motion where any part of the arm is within 20cm of shoulder level. The percentage of motion in which successful motion occurred over the total motion was reported.	Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Primary	Reachable Workspace - Mean Distance From Trunk, Successful Motions	Participants are instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. Successful motion is defined as motion where any part of the arm is within 20cm of shoulder level. The distance from the wrist to the trunk was reported for successful motion. Distance closer to the trunk indicates greater ability to correctly perform the task. Negative numbers would indicate the arm was below the trunk; positive numbers would indicate the arm was above the trunk.	Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Primary	Reachable Workspace - Area, Successful Motions	Participants will be instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. A larger workspace area indicates fewer upper extremity motor impairments.	Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Primary	Reachable Workspace - Mean Distance From Trunk, All Motions	Participants are instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. The distance from the wrist to the trunk was reported for all motion. Distance closer to the trunk indicates greater ability to correctly perform the task. Negative numbers would indicate the arm was below the trunk; positive numbers would indicate the arm was above the trunk.	Assessed at baseline (without the device) and after approximately 60 minutes of use with the device.
Secondary	Participant Satisfaction Survey	Closing survey of participants satisfaction with the device (impact, comfort, and responsiveness). Participants rated the experience as very positive, positive, neutral, negative, or very negative.	After study procedures have been performed, on day 2 (up to 5 minutes to complete survey)