Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury During Acute Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Inclusion rate
研究概览
简要总结
The goal of this clinical study is to test feasibility of a motor-cognitive training program in patients after mild to severe traumatic brain injury in an acute hospitalization setting.
The intervention is a step-based dual-task training, i.e. patients are presented with step patterns that they have to memorize and then execute in the tempo given by a metronome.
Researchers will assess the feasibility of the motor-cognitive training regarding acceptance and safety, user evaluation of the training and training performance.
详细描述
A traumatic brain injury (TBI) refers to a functional disorder of the brain with or without demonstrable injuries to the brain as a result of external force to the skull and/or brain. The most common causes are traffic accidents and falls. After TBI, impairments may occur in motor skills such as gait stability, static and dynamic balance and motor coordination as well as cognitive skills such as memory, dual- and multi-tasking (DT/MT), and psychomotor speed. Therefore, rapid improvement of motor and cognitive functioning and falls prevention are essential.
Dual-task training have been shown to improve gait performance and to reduce the risk of falling in some neurological disorders, such as Parkinson's disease and stroke. Although there are differences in the underlying pathophysiology between these neurological conditions and TBI, research has identified many common fall-risk factors and thus it can be expected that TBI patients would also profit from cognitive-motor dual-task training. However, research on the effects of such training in TBI patients in scarce. To our knowledge, there is only one study that has looked into the effects of dual-task motor-cognitive training in people with neurological conditions, including (but not specifically for) persons with TBI. For this reason, this study aims to assess the feasibility of a concept for stepping training (StepIt) that addresses motor as well as cognitive falls-related aspects in patients with TBI.
This study will be conducted as one-arm, monocentric intervention trial. After admission to the normal ward, patients potentially fulfilling the eligibility criteria will be informed orally and in writing about the study and asked if they wish to participate. All interested participants will then be screened for final inclusion. Baseline data collection will occur prior to the first training session and training evaluation will be conducted after 3 to max. 10 trainings (depending on the length of their hospital stay). During each training session individual training parameters will be documented. In addition to the usual care, the study participants receive the motor-cognitive training "StepIt". The "StepIt" will be conducted as an approximately 15-minute one on one training for at least 3 to max. 10 sessions during the stay at the hospital.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People diagnosed with mild (Glasgow Coma Scale 14-15), moderate (Glasgow Coma Scale 9-13) or severe (Glasgow Coma Scale 3-8) TBI
- •Age ≥ 18 years
- •Planned hospital treatment >24h on regular ward (non-ICU)
- •Physically able to stand (using cane if needed)
- •Able to give informed consent
排除标准
- •Limited vision and hearing ability (except facial injuries with monocular swelling)
- •Inability or contraindications to undergo the investigated intervention.
- •ICU stay only
- •Montreal Cognitive Assessment (MoCa) score < 16
结局指标
主要结局
Inclusion rate
时间窗: through study completion, an average of 9 months
Number of patients included in the study as percentages of patients fitting to the inclusion (resp. exclusion) criteria
Attrition rate
时间窗: through study completion, an average of 9 months
Number of Drop-outs as percentages of patients included in the study
Adherence rate
时间窗: through study completion, an average of 9 months (over all training sessions)
Number of attended training sessions as percentages of total possible training sessions
Compliance rate
时间窗: through study completion, an average of 9 months (over all training sessions)
Number of attended training minutes as percentages of the total possible training minutes
Recruitment rate
时间窗: through study completion, an average of 9 months
Number of patients fitting to the inclusion exclusion (resp. exclusion) criteria as percentages of persons with TBI admitted in the hospital during the study period
Security incidents
时间窗: through study completion, an average of 9 months (over all training sessions)
Total number of (Serious) Adverse Events (SAE/AE)
次要结局
- Patient Satisfaction(through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)))
- Training capacity(through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)))
- Physical and cognitive load(through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)))
- Improvement(through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)))
研究者
Eleftheria Giannouli
Principal Investigator
Swiss Federal Institute of Technology