Pusher SyndromeNCT02524015
Novel Treatment For Pusher Syndrome Using Physical Therapy
A study testing Novel physical therapy and Standard physical therapy in people with Pusher Syndrome, run by Loma Linda University.
Trial summary
The purpose of this study is to see if a specific physical therapy intervention speeds recovery from stroke-related "pusher syndrome." Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Pusher Syndrome
- What is being tested?
- Novel physical therapy and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent (within 2 months) unilateral stroke
- Burke Lateropulsion Scale ≥ 2
- Age 21 to 89 years
- Ability to provide informed consent
- English-speaking
Who cannot join
- Prior stroke within the past 6 months
- Cerebellar stroke
- Stroke-related brain imaging (MRI or CT) unavailable
- Global or receptive aphasia
- Prior documented neurologic disorder (e.g., multiple sclerosis, Parkinson's)
About this study
The purpose of this study is to see if a specific physical therapy intervention speeds recovery from stroke-related "pusher syndrome."
- Conditions
- Pusher Syndrome
- Being tested
- Novel physical therapy, Standard physical therapy
- Keywords
- stroke, pusher syndrome, contraversive pushing, lateropulsion, rehabilitation, physical therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel physical therapyOther
Standard physical therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard Physical Therapy Receives: Other: Standard physical therapy |
| Intervention | Experimental | Novel Physical Therapy Receives: Other: Novel physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from pusher syndrome as measured by changes in the Burke Lateropulsion Scale score over time.
The Burke Lateropulsion Scale (BLS) is used in the literature to measure the presence of pusher syndrome. We will measure BLS upon admission and at weekly intervals to monitor whether patients in the experimental group demonstrate faster recovery than the control group, as demonstrated by change in BLS score over change in time (days).
Measured: Initial, and then weekly until discharge from inpatient rehabilitation unit. Average inpatient stay is expected to be no greater than 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pusher SyndromeStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Kim, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524015
- Sponsor's protocol ID
- 5150231
- Status last verified
- Nov 2017
- First submitted
- 7 Aug 2015
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment For Pusher Syndrome Using Physical Therapy
- ClinicalTrials.gov ID
- NCT02524015
- Acronym / sponsor ID
- 5150231
- Conditions
- Pusher Syndrome
- Keywords
- stroke, pusher syndrome, contraversive pushing, lateropulsion, rehabilitation, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Aug 2015 (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.
The purpose of this study is to see if a specific physical therapy intervention speeds recovery from stroke-related "pusher syndrome."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Standard physical therapyStandard Physical Therapy |
| Intervention | Experimental | Other: Novel physical therapyNovel Physical Therapy |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recent (within 2 months) unilateral stroke
- Burke Lateropulsion Scale ≥ 2
- Age 21 to 89 years
- Ability to provide informed consent
- English-speaking
Key exclusion criteria (5 listed)
- Prior stroke within the past 6 months
- Cerebellar stroke
- Stroke-related brain imaging (MRI or CT) unavailable
- Global or receptive aphasia
- Prior documented neurologic disorder (e.g., multiple sclerosis, Parkinson's)
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 |
|---|---|---|
| Novel physical therapy | Other | Intervention |
| Standard physical therapy | Other | Control |
Primary outcome
Recovery from pusher syndrome as measured by changes in the Burke Lateropulsion Scale score over time.
Time frame: Initial, and then weekly until discharge from inpatient rehabilitation unit. Average inpatient stay is expected to be no greater than 4 weeks.
The Burke Lateropulsion Scale (BLS) is used in the literature to measure the presence of pusher syndrome. We will measure BLS upon admission and at weekly intervals to monitor whether patients in the experimental group demonstrate faster recovery than the control group, as demonstrated by change in BLS score over change in time (days).
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 21 Nov 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Novel physical therapy and Standard physical therapy in people with Pusher Syndrome, run by Loma Linda University.
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 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Recovery from pusher syndrome as measured by changes in the Burke Lateropulsion Scale score over time. (time frame: Initial, and then weekly until discharge from inpatient rehabilitation unit. Average inpatient stay is expected to be no greater than 4 weeks.). 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 21 Nov 2017.