- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02524015
Novel Treatment For Pusher Syndrome Using Physical Therapy
November 17, 2017 updated by: Mary Kim, Loma Linda University
The purpose of this study is to see if a specific physical therapy intervention speeds recovery from stroke-related "pusher syndrome."
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recent (within 2 months) unilateral stroke
- Burke Lateropulsion Scale ≥ 2
- Age 21 to 89 years
- Ability to provide informed consent
- English-speaking
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
Standard Physical Therapy
|
|
|
Experimental: Intervention
Novel Physical Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Initial, and then weekly until discharge from inpatient rehabilitation unit. Average inpatient stay is expected to be no greater than 4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
August 7, 2015
First Submitted That Met QC Criteria
August 13, 2015
First Posted (Estimate)
August 14, 2015
Study Record Updates
Last Update Posted (Actual)
November 21, 2017
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5150231
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pusher Syndrome
-
Hunan Provincial People's HospitalNot yet recruiting
-
Imperial College LondonHomerton University Hospital NHS Foundation TrustWithdrawnPusher SyndromeUnited Kingdom
-
Parc Sanitari Pere VirgiliUniversitat Internacional de CatalunyaCompletedPusher Syndrome | Subacute StrokeSpain
-
GlaxoSmithKlineNot yet recruiting
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Unravel Biosciences, Inc.RecruitingPitt Hopkins SyndromeColombia
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Neumedicines Inc.Department of Health and Human ServicesCompletedHematopoietic Syndrome Due to Acute Radiation SyndromeUnited States
-
Cairo UniversityCompleted
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Cairo UniversityCompleted
Clinical Trials on Standard physical therapy
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The University of QueenslandUnited States Department of Defense; Brooke Army Medical CenterNot yet recruitingPost Traumatic Headache | Persistent Post-concussive SymptomsUnited States
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University of Kansas Medical CenterCompletedLow Back Pain | Knee Osteoarthritis | Neck PainUnited States
-
Centre Hospitalier Universitaire de NīmesTerminatedTendinopathy | ShoulderFrance
-
Lawson Health Research InstituteCompleted
-
University of Health Sciences LahoreActive, not recruiting
-
Józef Piłsudski University of Physical EducationCompletedLow Back Pain | Chronic Pain | Physical TherapyPoland
-
Swiss Group for Clinical Cancer ResearchTerminatedMetastatic Colorectal CancerSwitzerland, Austria
-
University of PittsburghWithdrawnConcussionUnited States
-
University of HailCompletedCerebral PalsySaudi Arabia
-
TC Erciyes UniversityEnrolling by invitationCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyTurkey