Augmented Reality and Treadmill Training After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Community Balance and Mobility Scale
研究概览
简要总结
Up to 40 participants will be enrolled in this study in order to obtain complete data on 30 participants. The investigators will be assessing if Augmented reality in combination with treadmill training is safe and feasible to use in the clinical environment with participants who have chronic TBI and if there is a signal of effect that this intervention may be more beneficial than treadmill training alone or standard of care.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sustained a TBI requiring inpatient rehabilitation
- •> 1 year post TBI
- •18-65 years of age
- •Not currently participating in any other research study to address balance and gait impairment
- •Not currently participating in physical therapy
- •Ambulates with minimal assistance and/or assistive device
- •Self-report of ongoing balance deficits and mobility deficits
- •Score of 75 or below on CB&M
- •No history of other neurological disorders affecting balance
- •No seizures within the last year
- •No history of psychiatric disorder requiring hospitalization
- •Ability to follow directions and complete standardized instructions
排除标准
- •No pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).
研究组 & 干预措施
Augmented Reality+ Treadmill training
Participants allocated to this group will receive treadmill training with body weight support (BWS) incorporating augmented feedback games chosen to address clinically perceived deficits using the C-Mill training system.
干预措施: Augmented Reality (Behavioral)
Augmented Reality+ Treadmill training
Participants allocated to this group will receive treadmill training with body weight support (BWS) incorporating augmented feedback games chosen to address clinically perceived deficits using the C-Mill training system.
干预措施: Treadmill training (Behavioral)
Treadmill training
Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system.
干预措施: Treadmill training (Behavioral)
Over ground training/standard of care
Participants allocated to this group will receive over ground balance and mobility training that would be considered standard of care in outpatient rehabilitation.
干预措施: Over ground training/standard of care (Behavioral)
结局指标
主要结局
Community Balance and Mobility Scale
时间窗: Baseline to Week 8
13 activities scored from 0-96, higher numbers reflect greater balance
次要结局
- 10 meter walk test(Baseline, Week 4, and Week 8)
- Activities-Specific Confidence Scale(Baseline, Week 4, and Week 8)
- Timed Up and Go Cognitive Test(Baseline, Week 4, and Week8)
- 6 minute walk test(Baseline, Week 4, and Week 8)
- Timed Up and Go Manual(Baseline, Week 4, and Week 8)
- Global Impression of Change(Week 1, Week 2, Week 3, Week 4, and Week 8)
- Blood Pressure(Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8)
- Timed Up and Go(Baseline, Week 4, and Week 8)
- CNS Vital Signs - Reaction Time Domain(Baseline, Week 4, and Week 8)
- Physical Activity Enjoyment Scale(Week 1, Week 2, Week 3, and Week 4)
- CNS Vital Signs - Cognitive Flexibility Domain(Baseline, Week 4, and Week 8)
- CNS Vital Signs - Executive Functioning Domain(Baseline, Week 4, and Week 8)
- Heart Rate(Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8)
- CNS Vital Signs - Psychomotor Speed Domain(Baseline, Week 4, and Week 8)
研究者
Candace Tefertiller
Executive Director of Research and Evaluation
Craig Hospital