Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
研究概览
简要总结
The purpose of this study is to to determine how implementing a home-based virtual reality video (VR) game exercise program in young people with Multiple Sclerosis(MS) can improve disability outcomes by measuring its impact on cognitive assessments (BICAMS), subjective measures of cognitive, physical and psychosocial disability, and motor assessments (6MWT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Pediatric-Onset MS (<18 years) according to the 2017 revised McDonald criteria (relapsing-remitting)
- •Expanded Disability Status Scale (EDSS) ≤ 5.0
- •Relapse free for the past 30 days (including no corticosteroids)
- •No contraindications to physical activity, including pregnancy
- •Participant and parent (if between 15 and 18 years of age) written informed consent.
排除标准
- •History of visual provoked seizures
- •EDSS > 5.0
研究组 & 干预措施
Control Group
干预措施: Standard Management of Physical Activity (Behavioral)
Exercise Group
干预措施: VR active video game intervention (Device)
Exercise Group
干预措施: Educational session (Behavioral)
结局指标
主要结局
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
时间窗: 12 months
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
时间窗: 12 months
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
时间窗: 12 months
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
时间窗: 3 months
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
时间窗: 6 months
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
时间窗: 3 months
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
时间窗: 6 months
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
时间窗: 3 months
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
时间窗: 6 months
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
次要结局
- Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)(12 month)
- New Activity on MRI (T2 Lesions, Gd+)(12 months)
- Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire(12 months)
- Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)(12 month)
- Distance Walked as Assessed by the Six Minute Walk Test (6MWT)(12 months)
- Number of Clinical Relapses(12 months)
- Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)(12 month)
- Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.(6 month)
- Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.(3 month)
- Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire(6 months)
- Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.(1 month)
- Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)(3 Month)
- Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)(6 month)
- Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)(3 months)
- Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)(6 month)
- Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)(3 month)
- Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)(6 month)
- Distance Walked as Assessed by the Six Minute Walk Test (6MWT)(6 months)
研究者
Rohini Samudralwar
Assistant Professor
The University of Texas Health Science Center, Houston