Effects of Post-Stroke Upper Extremity Assistance

NCT05036642 | Completed Results FDA Device

• 2 other identifiers: IRB-61540SNI-BI1-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Arm Weakness as a Consequence of Stroke

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Participant Satisfaction Survey

  After study procedures have been performed, on day 2 (up to 5 minutes to complete survey)

Study Arms (1)

Stroke Survivors

EXPERIMENTAL

Stroke survivors with upper extremity motor impairments

Device: Compliant Passive Arm Support

Interventions

Compliant Passive Arm Support DEVICE

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.

Stroke Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University CHARM Lab

Stanford, California, 94305, United States

Location

Related 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.

  PMID: 17634933 BACKGROUND

Results Point of Contact

• Title: Allison Okamura
• Organization: Stanford University

aokamura@stanford.edu

(650) 723-3148

Study Officials

• Allison Okamura

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Mechanical Engineering

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 5, 2021
• Study Start: July 26, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)