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OpenTrials
Completed

NCT Number: NCT01563276

Postural Instability in Progressive Supranuclear Palsy

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Postural Instability in Progressive Supranuclear Palsy: Why do Patients With PSP Fall?

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2012
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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