Postural Instability in Progressive Supranuclear Palsy
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| ClinicalTrials.gov Identifier: NCT01563276 |
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Recruitment Status : Unknown
Verified March 2012 by Bernadette Schoneburg, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : March 26, 2012
Last Update Posted : March 26, 2012
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The purpose of this study is to better understand why individuals with Progressive Supranuclear Palsy (PSP) fall. Understanding the mechanism of gait and balance dysfunction in individuals with PSP may provide us with important early diagnostic tools, allowing for earlier identification of mobility problems and to better evaluate medical therapies aimed at improving motor disability.
The investigators will recruit 10 PSP, 10 PD and 10 healthy controls for the study. All subjects will be asked to come to the OHSU clinic at the Center for Health and Healing for an initial screening visit. They will meet with the primary investigator to conduct a brief interview and physical examination. In addition, they will be asked to answer questions regarding current and past medical illness, how often they fall and what kinds of medications they are on.
Subjects who agree to participate will come to the Oregon Clinical and Translational Research Institute (OCTRI) at OHSU for balance testing. Subjects will be asked to stand or sit on a movable platform with eyes open or closed. Prior to standing on the platform, the investigators will place 6 small sensors on body which are held in place by velcro straps (one on each wrist, ankles, chest and lower back). The platform will then be moved (tilt or slide) while subjects try to keep their balance. During all of the balance tests described above, body movements will be recorded from the sensors on the subjects' body. This data is directly recorded by a computer and analyzed to help us gain better understanding of the subjects' posture and their ability to remain up right.
| Condition or disease |
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| Progressive Supranuclear Palsy Parkinson's Disease |
| Study Type : | Observational |
| Estimated Enrollment : | 40 participants |
| Observational Model: | Case Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Postural Instability in Progressive Supranuclear Palsy: Why do Patients With PSP Fall? |
| Study Start Date : | December 2011 |
| Group/Cohort |
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Progressive Supranuclear Palsy
Patients with a diagnosis of probable or possible PSP as defined by the National Institute of Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy (NINDS-SPSP) diagnostic criteria.
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Parkinson's Disease
Idiopathic PD according to the UK Parkinson‟s Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)
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| Healthy Control |
- Relative contributions of vestibular and visual information to postural control in PSP [ Time Frame: Single visit. 2 hours. ]To gage the relative contributions of vestibular and visual information to postural control in PSP we will measure body sway using two different tests (LOS and SOT) while a patient stands on a movable force plate within a movable visual surround.
- Postural Response Latencies [ Time Frame: Single visit. 2 hours. ]Subjects will stand on a movable platform with a movable visual surround. Subjects will be asked to keep their balance while the platform is translated or roated.
- Gait patterns and postural transitions [ Time Frame: Single visit. 10 minutes. ]Subjects will be asked to rise from a chair, walk and turn. Ambulatory balance will be measured by a time up and go test (TUG). Six accelerometers will be placed on the subject and will measure parameters including arm swing, number of steps and turn duration.
- Perception of vertical and horizontal references [ Time Frame: Single visit. 2 hours. ]Subjects will perform two different tasks with their eyes closed while standing and sitting on a force plate that is tilting in the antero-posterior direction. They will perform the following two tasks: 1. Hold a rod parallel to the gravitional vertical 2. Hold a rod perpendicular to the tilting surface so it remains 90 degrees to the surface at all times. Six accelerometers will measure lower and upper body tilt.
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| Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Diagnosis of probable or possible PSP as defined by the National Institute of Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy (NINDS-SPSP) diagnostic criteria.
- Be able to ambulate and stand unassisted for 5 minutes
- Be able to cooperate with gait and balance testing
- Be able to give informed consent.
Exclusion Criteria:
- Cannot exhibit behavior or have dementia that precludes participation in the protocol
- Cannot have medical or orthopedic illness that, in the investigator's opinion, would impact the patient's postural control or ability to participate in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563276
| Contact: Anna M Lovelace, BS, BA | 503.494.9531 | lovelaca@ohsu.edu | |
| Contact: Bernadette Schoneberg, MD | 503.494.7230 | schonebu@ohsu.edu |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Anna M Lovelace, BS, BA 503-494-9531 lovelaca@ohsu.edu | |
| Principal Investigator: Bernadette Schoneberg, MD | |
| Principal Investigator: | Bernadette Schoneberg, MD | Oregon Health and Science University |
Additional Information:
| Responsible Party: | Bernadette Schoneburg, Movement Disorders Fellow, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01563276 History of Changes |
| Other Study ID Numbers: |
IRB00007924 |
| First Posted: | March 26, 2012 Key Record Dates |
| Last Update Posted: | March 26, 2012 |
| Last Verified: | March 2012 |
Keywords provided by Bernadette Schoneburg, Oregon Health and Science University:
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Progressive Supranuclear Palsy PSP Falls Gait |
Balance Parkinson's Disease PD |
Additional relevant MeSH terms:
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Parkinson Disease Paralysis Supranuclear Palsy, Progressive Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders |
Neurodegenerative Diseases Neurologic Manifestations Signs and Symptoms Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Eye Diseases |