Power Wheelchair Joystick Use in Spastic Cerebral Palsy

NCT00337688 | Completed

• 1 other identifier: 0512006
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are over 750,000 individuals in the U.S. 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, Parkinson's Disease, stroke, or a variety of other disabilities.

Conditions

Cerebral Palsy; Spasticity

Keywords

Cerebral Palsy; Spasticity; Joystick; Wheelchair; rehabilitation

Interventions

isometric joystick DEVICE

isometric joystick

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with CP and controls

You may qualify if:

• subjects must be between the ages of 12-80
• subjects must be able to give written informed consent or consent by proxy to participate
• subjects with the diagnosis of CP must have a score of 2 or 3 on the Modified Ashworth Scale in at least one of the following in the operating limb: wrist flexors, wrist extensors, elbow flexors, or elbow extensors
• control subjects must have a Modified Ashworth score of 0 for all of the above muscle groups in both upper limbs
• subjects must have the minimal motor ability necessary to participate in the trial. This will be measured as follows: after 3 trials, subjects must be able to complete a basic virtual driving with an average minimum speed of no less than 1.2 m/s, an average trial time of no more than 18 seconds, and an average deviation of the center of the virtual wheelchair of no more than 1.5 m from the path center, for each of the two joysticks used. These values are derived from Americans with Disabilities Act (ADA) standard dimensions and human walking speed.

You may not qualify if:

• subjects who are not able to tolerate sitting for 2 hours (the estimated length of the experiment)
• subjects who have active pelvic or thigh wounds (they may be worsened by prolonged sitting)
• subjects with a history of seizures in the last 90 days (uncontrolled seizures may be induced by a computer screen task)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Human Engineering Research Laboratories: collaborator

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brad Dicianno, MD

  Human Engineering Research Laboratories

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 14, 2011

Record last verified: 2011-09