An Engineering-Based Balance Assessment and Training Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Root Mean Squared Deviation between Center of Mass and Center of Base of Support (RMSD)
研究概览
简要总结
This is a proposal to develop a Balanced Reach Training Protocol (BRTP) to evaluate and train dynamic standing balance. The BRTP is based upon the Balanced Reach Test (BRT) that the investigators previously developed and validated. In the BRT subjects stand and point to a target disk moving unpredictably across a large projection screen in front of them without stepping. Body movements undertaken to track the disk are integral to many daily activities and represent an important class of "expected" balance disturbances that can precipitate falls. The BRTP employs engineering and psychophysical methods, and exploits advances in real time computing in a novel and innovative way to more effectively evaluate and train balance function. The BRTP presents a challenging reaching/tracking task that subjects perform at their limit of balance. The BRTP is an objective, quantitative test that can evaluate balance function without floor or ceiling effects, and train balance across the spectrum of aging, disease, and injury.
详细描述
This study comprises two Specific Aims: SA-1) Development of a Balance Assessment and Training Platform (BATP) based upon the existing BRT; and SA-2) Evaluation of the BATP Assessment Module's test-retest reliability and the Training Module's motor learning effect.
Methods related to Specific Aim 1 SA-1.1: Develop a BATP based on the BRT that incorporates real-time computing and an Adaptive Staircase Algorithm to establish subjects' Limit of Balance. Modify the BRT's experimental control algorithm and hardware setup such that data from our extant measurement systems are continuously streamed to a Real Time Computing Workstation and read by the experimental control algorithm, enabling it to monitor foot movement and compute key performance measures on an ongoing basis. These measures will include Root Mean Square tracking Error (RMSE) and Root Mean Squared Deviation (RMSD) between the ground plane projection of Center of Mass (CoM) and the center of the Base of Support (BoS). Incorporate an Adaptive Staircase Algorithm into the real time experimental control algorithm to establish the target positions corresponding to Limit of Balance, based on foot movement (i.e., stepping).
SA-1.2: Replace the projection screen with Virtual Reality eyewear. The experimental control algorithm will be further modified to display a virtual sphere in the virtual reality eyewear. The virtual reality eyewear will provide a direct view of the actual physical environment but also show the sphere following the trajectory specified by the Adaptive Staircase Algorithm, or the assessment or training modules. When the subject's tracking fingertip contacts the center of the target sphere it will provide visual feedback by changing color.
SA-1.3: Develop the BATP's Assessment and Training modules. The Assessment Module consists of measuring the subject's Limit of Balance, computing the manifold bounding target motion, and the target's motion within the manifold; as just described. The harnessed subject then tracks the disk for 90 sec. After a 2 1/2 minute rest the process is repeated a second time. Tracking and resting durations can be varied to optimize measurement quality and accommodate individual subject needs and capabilities.
The Training Module operates in a loop that presents an operator-specified number of training bouts. One training bout consists of measuring Limit of Balance, computing the manifold and target motion, presenting the tracking target for five minutes, and pausing for a 2 1/2 minute rest period before signaling the operator to begin the next bout. Tracking and resting durations can be varied to optimize training efficacy and accommodate individual subject needs and capabilities. For this proposal a training session will consist of five bouts and last approximately 60 minutes. As in the Assessment Module, subjects will be harnessed while performing the tracking task to guard against falling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-40 years old and in good health; 60 years and older
- •For Ages 60 or older-stroke with persistent motor function deficit.
- •For ages 18-40-experienced no falls in the past year. Fall is defined as a fall that occurs under conditions that an able body individual would not fall.
- •Able to perform the balanced reach task without assistive devices for 90 seconds
- •Able to perform a sit-to-stand with minimal assistance and walk 10 meters without human assistance
- •Adequate language and neurocognitive function to give adequate informed consent & to participate in testing and training
- •Vision adequate to see a 1 inch diameter black disk against a white background at 3 feet
- •Able to tolerate the use of Virtual Reality eyewear for ~10 minutes
排除标准
- •Clinical history of:
- •Any health condition that the study team deems would preclude safe completion of the BATP
- •For ages 18-40-History of a stroke, orthopedic deficits, or sensorimotor deficits
- •Body Mass Index (BMI) >40
- •Excessive daily alcohol consumption (>3 oz. liquor; >12 oz. wine; or >36 oz. beer) or illicit drug abuse
- •For ages 60 and older-Dementia based on Montreal Cognitive Assessment (MOCA) score of less than 23 for more than 9th grade education.
- •Neurological disease other than stroke, such as Parkinson's disease. Vestibular disorders sufficient to preclude safe completion of the BATP or MMBI
- •Poorly controlled hypertension (>190/105) on at least two separate occasions
- •Poorly controlled type 1 or 2 diabetes (HbA1c >10)
- •Recent hospitalization for severe disease or surgery (<3 months)
- •Congestive heart failure or valvular dysfunction symptomatic with ordinary activities (NYHA II)
- •Self-reported Pregnancy
- •Symptomatic orthostatic hypotension
研究组 & 干预措施
STR
Older people who have suffered a stroke
干预措施: Balanced Reach Assessment and Training Protocol (Diagnostic Test)
结局指标
主要结局
Root Mean Squared Deviation between Center of Mass and Center of Base of Support (RMSD)
时间窗: Assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week
Measure of Balance Capability. Root Mean Squared Deviation (RMSD) records the root mean squared distance between the ground plane projection of whole-body Center of Mass and the center of the Base of Support during performance of the balanced reach task, in centimeters. It ranges from zero to the distance from the center of the Base of Support to the boundary of the Base of Support. Larger deviations indicate better performance than smaller deviations.
次要结局
- Falls Efficacy Scale(Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week))
- Multi-Directional Reach Test(Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week))