Speed of Processing Training in Patients With Parkinson's Disease and Healthy Older Adults
The Effect of Speed of Processing Training on Pedestrian Behavior in Patients With Parkinson's Disease and Healthy Older Adults
2 other identifiers
interventional
88
1 country
1
Brief Summary
The purpose of this prospective, within-subject randomized cross-over design study is to determine if a computer training program (Speed of Processing Training - SOPT) improves safe pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a virtual reality pedestrian environment. Pedestrian injury poses significant risk to healthy older adults and patients with Parkinson's disease. Several age-related changes, including slowing of visual processing speed, increase risky pedestrian behavior. This study will determine if SOPT improves pedestrian behavior in patients with Parkinson's disease and healthy older adults and evaluate the persistence of the SOPT training effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMarch 26, 2018
March 1, 2018
3 years
October 7, 2016
March 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time to contact
Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls
3 months
Secondary Outcomes (3)
Useful Field of View (UFOV)
3 months
Executive function (MoCA, Trails, Stroop)
3 months
Vigilance
3 months
Study Arms (4)
Control Initial Training Group
ACTIVE COMPARATORHealthy Controls will receive initial SOPT training and will be compared against controls in the delayed training group and the PD subjects in the initial training group
Control Delayed Training Group
ACTIVE COMPARATORHealthy Controls will receive delayed SOPT training and will be compared against controls in the initial training group and the PD subjects in the delayed training group
PD Initial Training Group
OTHERPD subjects will received initial SOPT training and will be compared against PD subjects in the delayed training group and the control subjects in the initial training group
PD Delayed Training Group
OTHERPD subjects will receive delayed SOPT training and will be compared against PD subjects in the initial training group and the control subjects in the delayed training group
Interventions
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
Eligibility Criteria
You may qualify if:
- Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
- On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
- Age ≥50 at the time of entry into the study
- Age of onset of Parkinson's disease 45 - 85 years old
- Asymmetric onset of PD
- Progressive motor symptoms of PD
- Hoehn and Yahr stages 1-4
- Ability to walk up and down a single stair step
- Access to a computer with internet
You may not qualify if:
- Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
- Neuroleptic treatment at time of onset of Parkinsonism
- Active treatment with a neuroleptic at time of study entry
- History of multiple strokes with stepwise progression of Parkinsonism
- History of multiple head injuries
- Inability to walk without assistance, including a cane, wheelchair, or walker
- Cognitive dysfunction that would prevent subject's ability to perform virtual reality simulation, speed of processing training, or complete questionnaire
- Blindness
- Any medical condition that, based on discretion of the PI, would prevent the subject's ability to participate in the study
- Age ≥50 at the time of entry into the study
- On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
- Ability to walk up and down a single stair step
- Access to a computer with internet
- Parkinson's disease or other neurodegenerative disorder
- Inability to walk without assistance, including a cane, wheelchair, or walker
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Amara, MD, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 11, 2016
Study Start
February 1, 2015
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
March 26, 2018
Record last verified: 2018-03