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
調査の概要
詳細な説明
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. Persons with Parkinson's disease (PD) are at even higher risk of pedestrian injury due to motor and non-motor symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms including slowness, tremor, stiffness, and balance problems. Visual processing speed abnormalities, anxiety, and cognitive problems are common non-motor symptoms.
The Useful Field of View (UFOV®) test is a measure of visual processing speed. The UFOV® test is performed on a touch-screen computer that displays objects in the central and peripheral visual fields for brief durations. Successful performance on the test requires integration of visual sensory information and higher-order cognitive processing. Our own research has shown that the UFOV® test performance correlates with pedestrian behavior in PD patients.
Speed of Processing Training (SOPT) is a computer-based training that uses visual exercises to improve cognitive processing. The training involves identifying and localizing visual information quickly in increasingly demanding visual displays. SOPT has been demonstrated to improve performance on the UFOV test in healthy older adults and PD patients. It is hypothesized that SOPT training will improve pedestrian safety in healthy older adults and PD patients.
In the proposed study, we will use a within-subject, randomized, controlled, cross-over design to evaluate 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 and if the effects of training persist long-term.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35233
- University of Alabama at Birmingham
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria Parkinson's disease Subjects:
- 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
Exclusion Criteria Parkinson's disease Subjects:
- 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
Inclusion Criteria Control Subjects:
- 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
Exclusion criteria Control Subjects:
- Parkinson's disease or other neurodegenerative disorder
- 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 questionnaires
- Blindness
- Any medical condition that, based on the discretion of the PI, would prevent the subject's ability to participate in the study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Control Initial Training Group
Healthy 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
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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.
他の名前：
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アクティブコンパレータ：Control Delayed Training Group
Healthy 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
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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.
他の名前：
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他の：PD Initial Training Group
PD 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
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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.
他の名前：
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他の：PD Delayed Training Group
PD 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
|
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to contact
時間枠：3 months
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Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls
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3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Useful Field of View (UFOV)
時間枠：3 months
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Difference in UFOV total score between baseline and immediate post-training assessments in PD and healthy controls
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3 months
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Executive function (MoCA, Trails, Stroop)
時間枠：3 months
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Difference in MoCA, Trails, and Stroop between baseline and immediate post-training assessments in PD and healthy controls
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3 months
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Vigilance
時間枠：3 months
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Differences in vigilance as measured by psychomotor vigilance task between baseline and immediate post-training assessments in PD and healthy controls
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3 months
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協力者と研究者
捜査官
- 主任研究者：Amy Amara, MD, PhD、University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
パーキンソン病の臨床試験
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