Arm Weakness as a Consequence of StrokeNCT03867838
Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion
A study testing compliant support in people with Arm Weakness as a Consequence of Stroke, run by Stanford University at 1 site in United States.
Trial summary
The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness. 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 support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2019to 1 Oct 2020
- 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 to 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
About this study
Official title: Effects of Post-Stroke Upper Extremity Assistance
The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness.
- Conditions
- Arm Weakness as a Consequence of Stroke
- Being tested
- compliant support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compliant supportDevice
Participants will be given compliant arm support and their reachable workspace measured
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors | Experimental | Stroke survivors with upper extremity motor impairments Receives: Device: compliant support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Reachable Workspace
Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters).
Measured: baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
Secondary outcomes (1)
Percent Change From Baseline in Biceps Activation
Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies.
Measured: baseline and while using support device (up to 10 seconds per assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start14 Jun 2019
- Primary completion27 Apr 2020
- Study completion1 Oct 2020
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 (2)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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Okamura, Stanford University
- Investigators
- Allison Okamura, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867838
- Sponsor's protocol ID
- IRB-49194
- Other IDs
- SNI-BI1-02
- Status last verified
- Feb 2021
- First submitted
- 5 Mar 2019
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Simpson CS, Okamura AM, and Hawkes EW. Exomuscle: An inflatable device for shoulder abduction support. 2017 IEEE International Conference on Robotics and Automation (ICRA) 2017; pp. 6651-6657.
Simpson C, Huerta B, Sketch S, Lansberg M, Hawkes E, and Okamura A. Upper Extremity Exomuscle for Shoulder Abduction Support. IEEE Transactions on Medical Robotics and Bionics. 2020; 2(3):474-484.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. 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
- NCT03867838
- Acronym / sponsor ID
- IRB-49194
- Conditions
- Arm Weakness as a Consequence of Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness.
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 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 to 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 supportParticipants will be given compliant arm support and their reachable workspace measured | Device | Stroke survivors |
Primary outcome
Percent Change From Baseline in Reachable Workspace
Time frame: baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters).
1 secondary outcome
Percent Change From Baseline in Biceps Activation
Time frame: baseline and while using support device (up to 10 seconds per assessment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSimpson CS, Okamura AM, and Hawkes EW. Exomuscle: An inflatable device for shoulder abduction support. 2017 IEEE International Conference on Robotics and Automation (ICRA) 2017; pp. 6651-6657.
- Results publicationSimpson C, Huerta B, Sketch S, Lansberg M, Hawkes E, and Okamura A. Upper Extremity Exomuscle for Shoulder Abduction Support. IEEE Transactions on Medical Robotics and Bionics. 2020; 2(3):474-484.
- Individual participant dataSharing planned: No
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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 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 23 Feb 2021. 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 23 Feb 2021). 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?
Percent Change From Baseline in Reachable Workspace (time frame: baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)). 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 NCT03867838, which also lists 2 linked publications.
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 23 Feb 2021.