Arm Weakness as a Consequence of StrokeNCT05036642

Effects of Post-Stroke Upper Extremity Assistance

A study testing Compliant Passive Arm Support in people with Arm Weakness as a Consequence of Stroke, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arm Weakness as a Consequence of Stroke
What is being tested?: Compliant Passive Arm Support
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2022to 7 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University CHARM Lab
Stanford, California, 94305

Other trials in United States

About this study

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
Being tested: Compliant Passive Arm Support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Compliant Passive Arm SupportDevice
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.

Study groups in NCT05036642
Study group	Role	What they receive
Stroke Survivors	Experimental	Stroke survivors with upper extremity motor impairments Receives: Device: Compliant Passive Arm Support

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline (without the device) and after approximately 60 minutes of use with the device.

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 20227 Sep 2022

First posted5 Sep 2021
Study start26 Jul 2022
Primary completion7 Sep 2022
Study completion7 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arm Weakness as a Consequence of StrokeStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05036642
Sponsor's protocol ID: IRB-61540
Other IDs: SNI-BI1-02
Status last verified: Oct 2023
First submitted: 31 Aug 2021
Last updated: 25 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 17634933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
Stroke, Chronic Stroke Patients
Recruiting
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Stroke, Arm Weakness as a Consequence of Stroke
Recruiting
The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.
Stroke, Stroke Patients
Not yet recruiting
kTMP in Chronic Stroke
Stroke, Chronic Stroke Patients

All Arm Weakness as a Consequence of Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Post-Stroke Upper Extremity Assistance
ClinicalTrials.gov ID: NCT05036642
Acronym / sponsor ID: IRB-61540
Conditions: Arm Weakness as a Consequence of Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 26 Jul 2022 (actual)
Primary completion: 7 Sep 2022 (actual)
Study completion: 7 Sep 2022 (actual)
First posted: 5 Sep 2021 (actual)
Results: Posted 25 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Stroke Survivors	Experimental	Device: Compliant Passive Arm SupportStroke survivors with upper extremity motor impairments

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Compliant Passive Arm SupportThe 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.	Device	Stroke Survivors

Primary outcome

Wolf Motor Function Test - Change in Functional Score by Task (WMFT)
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
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.
Wolf Motor Function Test - Change in Completion Time by Task
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
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.
Wolf Motor Function Test - Weight Lifted
Time frame: Assessed at baseline (without the device) and after approximately 5 minutes of use with the device.
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.
Percentage of Successful Motions
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
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.
Reachable Workspace - Mean Distance From Trunk, Successful Motions
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
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.
Reachable Workspace - Area, Successful Motions
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
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.
Reachable Workspace - Mean Distance From Trunk, All Motions
Time frame: Assessed at baseline (without the device) and after approximately 60 minutes of use with the device.
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.

1 secondary outcome

Participant Satisfaction Survey
Time frame: After study procedures have been performed, on day 2 (up to 5 minutes to complete survey)

Results and safety

Results posted to the registry on 25 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot Phase	1	1
Evaluation Phase	0	0

Primary outcome: Wolf Motor Function Test - Change in Functional Score by Task (WMFT)

Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.. Count of units. Unit: Tasks

Measure	Evaluation Phase n = 11
Increase functionality	7
No change	3
Decreased functionality	5

Population analysed: Data for this outcome were collected from participants in the Evaluation phase only.

Primary outcome: Wolf Motor Function Test - Change in Completion Time by Task

Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.. Count of units. Unit: Tasks

Measure	Evaluation Phase n = 11
Increased time	3
No change	0
Decreased time	12

Population analysed: Data for this outcome were collected from participants in the Evaluation phase only.

Primary outcome: Wolf Motor Function Test - Weight Lifted

Time frame: Assessed at baseline (without the device) and after approximately 5 minutes of use with the device.. Mean (Standard Deviation). Unit: pounds

Measure	Evaluation Phase n = 11
No Device	4.6 (4.8)
With Device	6.1 (4.8)

Population analysed: Data for this outcome were collected from participants in the Evaluation phase only.

Primary outcome: Percentage of Successful Motions

Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.. Mean (Standard Deviation). Unit: percentage of motions

Measure	Evaluation Phase n = 11
No device	57.5 (42.28)
With device	69.84 (45.07)

Evaluation Phase: p = 0.02, Wilcoxon (Mann-Whitney)

Population analysed: Data for this outcome were collected from participants in the Evaluation phase only.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot Phase	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Evaluation Phase	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17634933Sukal 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.
Individual participant dataSharing planned: No

Related trials for Arm Weakness as a Consequence of Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Allison Okamura principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Compliant Passive Arm Support in people with Arm Weakness as a Consequence of Stroke, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wolf Motor Function Test - Change in Functional Score by Task (WMFT) (time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05036642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.