StrokeNCT02190734
Pushing Behaviors in Individuals Post-stroke
A study testing Sitting in wheel chair, Gait training on treadmill and Gait training overground in people with Stroke, run by Shirley Ryan AbilityLab at 2 sites in United States.
Trial summary
Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stroke
- What is being tested?
- Sitting in wheel chair, Gait training on treadmill and Gait training overground
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- score >0 in each subsection of the Scale for Contraversive Pushing
- admitted to the Rehabilitation Institute of Chicago inpatient rehabilitation setting
- stroke within previous 180 days
- consent to participate in the study
- ambulating greater than 150' at a time prior to stroke
Who cannot join
- other neurologic diagnoses
- weight bearing precautions, orthopedic injuries, or other medical co-morbidities that prevent adherence to the study protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Rehabilitation Hospital of the Pacific
Honolulu, Hawaii, 96817
About this study
Official title: Inpatient Rehabilitation Treatments and Effect on Pushing Behaviors in Individuals Post-stroke
Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground.
The investigators do not think there will be a change with sitting in the wheelchair, but the investigators think there may be an improvement in pushing behaviors after walking training.
Read the detailed description
The study population of interest is primarily individuals in inpatient rehabilitation.
- Conditions
- Stroke
- Being tested
- Sitting in wheel chair, Gait training on treadmill, Gait training overground
- Keywords
- Stroke, Pusher Syndrome, Lateropulsion, Pushing Behaviors, Burke Lateropulsion Scale
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting in wheel chairOther
Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes
Gait training on treadmillOther
Walking on a treadmill with or without body weight support during 30 minute treatment
Gait training overgroundOther
Walking overground with or without body weight support during 30 minute treatment
| Study group | Role | What they receive |
|---|---|---|
| wheelchair, walking on treadmill, walking overground | Other | Sitting in wheel chair Gait training on treadmill Gait training overground Receives: Other: Sitting in wheel chair; Other: Gait training on treadmill; Other: Gait training overground |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burke Lateropulsion Scale
Clinical measure of pushing behaviors in supine, sitting, standing, walking, and transfers will be performed before and after each 30 minute training session.
Measured: Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas G Hornby, Shirley Ryan AbilityLab
- Investigators
- T. George Hornby, PT, PhD, Principal investigator, Rehabilitation Institute of Chicago, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190734
- Sponsor's protocol ID
- Pusher1
- Status last verified
- Apr 2019
- First submitted
- 21 May 2014
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Rehabilitation Treatments and Effect on Pushing Behaviors in Individuals Post-stroke
- ClinicalTrials.gov ID
- NCT02190734
- Acronym / sponsor ID
- Pusher1
- Conditions
- Stroke
- Keywords
- Stroke, Pusher Syndrome, Lateropulsion, Pushing Behaviors, Burke Lateropulsion Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground.
The investigators do not think there will be a change with sitting in the wheelchair, but the investigators think there may be an improvement in pushing behaviors after walking training.
Detailed description
The study population of interest is primarily individuals in inpatient rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wheelchair, walking on treadmill, walking overground | Other | Other: Sitting in wheel chair, Other: Gait training on treadmill, Other: Gait training overgroundSitting in wheel chair Gait training on treadmill Gait training overground |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- score >0 in each subsection of the Scale for Contraversive Pushing
- admitted to the Rehabilitation Institute of Chicago inpatient rehabilitation setting
- stroke within previous 180 days
- consent to participate in the study
- ambulating greater than 150' at a time prior to stroke
Key exclusion criteria (2 listed)
- other neurologic diagnoses
- weight bearing precautions, orthopedic injuries, or other medical co-morbidities that prevent adherence to the study protocol
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 |
|---|---|---|
| Sitting in wheel chairPlacebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes | Other | wheelchair, walking on treadmill, walking overground |
| Gait training on treadmillWalking on a treadmill with or without body weight support during 30 minute treatment | Other | wheelchair, walking on treadmill, walking overground |
| Gait training overgroundWalking overground with or without body weight support during 30 minute treatment | Other | wheelchair, walking on treadmill, walking overground |
Primary outcome
Burke Lateropulsion Scale
Time frame: Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period
Clinical measure of pushing behaviors in supine, sitting, standing, walking, and transfers will be performed before and after each 30 minute training session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
T. George Hornby, PT, PhD principal investigator
Rehabilitation Institute of Chicago, University of Illinois at Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting in wheel chair, Gait training on treadmill and Gait training overground in people with Stroke, run by Shirley Ryan AbilityLab at 2 sites 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 5 inclusion and 2 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Burke Lateropulsion Scale (time frame: Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2019.