Neural Markers of Static & Dynamic Balance Before & After Yoga in Adults With Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Balance Performance from Baseline to Post-Intervention Timepoint
研究概览
简要总结
The feasibility study is designed to assess the feasibility of conducting a group yoga intervention and acquiring neuroimaging data in adults with chronic brain injury.
详细描述
In the United States in 2014, nearly 2.9 million individuals sustained traumatic brain injuries that resulted in emergency department visits, hospitalizations, and death. Traumatic brain injury (TBI) is caused by trauma, or an external force that creates rapid acceleration and deceleration of the brain within the skull creating lasting neurophysiological dysfunction. Although there are many effective treatment strategies for the weeks and months post-injury (e.g. intensive, multi-disciplinary in-patient rehabilitation), millions of individuals are living with residual disability from brain injury following discharge to home. This residual disability can include significant social, cognitive, emotional, and physical impairment. To date, there are limited strategies for treating the residual deficits of chronic brain injury. One such physical deficit is balance impairment, which is associated with increased fall risk, reduced community integration, and decreased quality of life. The use of intensive, holistic rehabilitation may be effective for improving balance and other impairments in individuals with chronic brain injury. Yoga, a holistic treatment option, is thought to be more therapeutic than traditional exercise because of the integration of the mind, body, and spirit. Further, yoga can be modified to accommodate individual abilities and needs. And, unlike formal rehabilitation, yoga does not need to be approved by insurance or prescribed by a physician and adapted yoga is available in the community. Thus, yoga is readily available, so long as yoga instructors are trained to appropriately modify activities. Recently, the research team found that group yoga improved balance performance in seven adults with chronic brain injury. This study is designed to test the feasibility of conducting another group yoga intervention and acquiring neuroimaging data before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, ages 18+
- •Diagnosis of traumatic brain injury (TBI) or acquired brain injury (ABI) that occurred ≥ 6 months prior,
- •Self-reported balance limitations.
排除标准
- •Ability to engage in non-adapted (i.e. mainstream) yoga classes
- •Standard contraindications for MRI (e.g. metal plates in head, claustrophobia, etc.)*
- •Individuals could still participate in the group yoga intervention even if they could not complete MRI scans.
结局指标
主要结局
Change in Balance Performance from Baseline to Post-Intervention Timepoint
时间窗: Baseline was ~ 2 weeks before the start of group yoga; Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Six balance tasks, adapted from the Berg Balance Scale, were administered with simultaneous functional near infrared spectroscopy (see secondary outcomes). Each balance task was evaluated using Functional Independence Measure (FIM) scoring, ranging from 0 (dependent, unable to do) to 7 (independent, able to do without help). A composite score was generated by averaging FIM scores from each balance task. Change in balance was quantified as the difference in the post-intervention balance composite score and the baseline balance composite score.
Change in Executive Functioning from Baseline to Post-Intervention Timepoint
时间窗: Baseline was ~ 2 weeks before the start of group yoga; Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Executive function was assessed with a self-report measure, the Behavior Rating Inventory of Executive Function - Adult Version. The BRIEF-A includes nine clinical scales: inhibit, self-monitor, plan/organize, shift, initiate, task monitor, emotional control, working memory and organization of materials. Items are self-rated using a three-point frequency scale (1 = never; 2=sometimes; 3=often). These items contribute to two broad indexes, behavioral regulation and metacognition, which are combined for a summary score. Raw scores are transformed into a T-score. Higher T scores reflect more reported problems and T scores at or above 65 are considered clinically significant.
次要结局
- Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Baseline(Baseline was ~ 2 weeks before the start of group yoga.)
- Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Baseline(Baseline was ~ 2 weeks before the start of group yoga.)
- Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Post-Intervention(Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.)
- Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Post Intervention(Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.)
- Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Baseline(Baseline was ~ 2 weeks before the start of group yoga.)
- Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Post-Intervention(Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.)
- Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Baseline(Baseline was ~ 2 weeks before the start of group yoga.)
- Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Post-Intervention.(Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.)