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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01563276
Other study ID # IRB00007924
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2011
Est. completion date May 10, 2013

Study information

Verified date September 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 10, 2013
Est. primary completion date May 10, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

1. 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.

2. Be able to ambulate and stand unassisted for 5 minutes

3. Be able to cooperate with gait and balance testing

4. Be able to give informed consent.

Exclusion Criteria:

1. Cannot exhibit behavior or have dementia that precludes participation in the protocol

2. 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.

Study Design


Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relative contributions of vestibular and visual information to postural control in PSP 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. Single visit. 2 hours.
Secondary Postural Response Latencies 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. Single visit. 2 hours.
Secondary Gait patterns and postural transitions 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. Single visit. 10 minutes.
Secondary Perception of vertical and horizontal references 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. Single visit. 2 hours.
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