Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337688
Status:
COMPLETED
Last Update Posted:
2011-09-14
First Post:
2006-06-14
Brief Title:
Power Wheelchair Joystick Use in Spastic Cerebral Palsy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Joystick Use for Virtual Electric Power Wheelchair Driving in Individuals With Spastic Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are over 750000 individuals in the US with Cerebral Palsy CP Up to 46 of adults with CP report limited mobility in their communities However upper limb spasticity and problems with movement can make the independent use of a wheelchair difficult Forty percent of individuals who desire mobility via electric wheelchairs are precluded from using them because of problems with upper limb function No studies to date have produced devices that definitively improve mobility for these individuals We will recruit 22 subjects with Spastic CP and 22 age and gender matched control subjects without apparent disability from advertisements mailings and outpatient clinics Both a conventional joystick MSJ and a novel joystick that is customized for each subject will each be used six different computer screen tasks that simulate driving a wheelchair on a path We will compare subjects and joysticks based on driving performance Understanding problems with driving will help us to design joysticks and other assistive devices not only for CP but for Traumatic Brain Injury Spinal Cord Injury Parkinsons Disease stroke or a variety of other disabilities
Detailed Description:
There are over 750000 individuals in the US with Cerebral Palsy CP Up to 46 of adults with CP report limited mobility in their communities However upper limb spasticity and motor control impairment can make the independent use of a wheelchair difficult Forty percent of individuals who desire mobility via electric wheelchairs are precluded from using them because of problems with upper limb function including motor sensory or cognitive impairments that can make the use of a conventional joystick difficult No studies to date have produced devices that definitively improve mobility for these individuals We will recruit 22 subjects with Spastic CP and 22 age and gender matched control subjects without apparent disability from advertisements mailings and outpatient clinics Both a conventional motion sensing joystick MSJ and a novel isometric joystick that is customized for each subject will each be used to maneuver a sprite on a computer screen in six different tasks Each task involves a path with 90-degree turns Two tasks have paths that are completely visible to the subject while four have paths that appear either immediately or at 1 2 or 3 seconds ahead of the sprite Because subjects with CP and control subjects are likely to drive at different speeds subjects will drive under conditions of freely chosen speed and with speed controlled at 12 ms Joystick input signals that represent the sprites velocity and position will be recorded Changes in direction and speed average deviation from path center number of boundary violations start and stop reaction times response times to turns and duration of subject movement will be calculated We will use a Repeated Measures design treating speed as a covariate under the condition when it is freely chosen We hypothesize that regardless of joystick or speed condition subjects with Spastic CP will have more direction and speed changes greater average deviation from path center more boundary violations prolonged reaction times and response times to turns and prolonged subject movement time compared to controls We hypothesize that regardless of joystick or speed condition decreasing warning time before turns will be correlated with more direction and speed changes greater average deviation from path center more boundary violations and prolonged subject movement time and that the magnitude of these changes will be greater for those with Spastic CP We hypothesize that regardless of speed condition subjects with Spastic CP when using a MSJ compared to the isometric joystick will have more direction and speed changes greater average path deviation more boundary violations and prolonged subject movement Understanding driving task deficits and warning time for movement decisions will help to identify customization parameters for joysticks and other assistive devices not only for CP but for Traumatic Brain Injury Spinal Cord Injury Parkinsons Disease stroke or a variety of other disabilities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None