Cognitive-motor Training on a Labile Surface in Stroke Inpatients: Feasibility and Preliminary Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Adherence rate
研究概览
简要总结
Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.
This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.
详细描述
As a result of the impairment in cognitive and motor functioning after a stroke, the balance ability worsens and gait becomes unsteady. Of all complications following a stroke, falls are one of the most prevalent and the frequency of total fall events is rising with time after the stroke. Since falls are in general the leading reason for injuries in older adults and about a third of persons older than 65 years fall once a year, there is an overall need for interventions.
Balance training is an established form of exercise in people suffering from stroke and other neurological disabilities. However, cognitive-motor training is superior to single physical training in improving motor functioning e.g. gait speed and walking endurance in stroke patients. More specifically, compared to sequential (e.g. cycling followed by cognitive training) and simultaneous-additional (e.g. cycling while solving an arithmetical task), simultaneous-incorporated motor-cognitive training (e.g. any type of training in which the cognitive task is "incorporated" into the motor task, i.e. the cognitive task is a relevant prerequisite to successfully solve the motor-cognitive task) seems to be the most promising training type for improving gait speed and potentially other functions in stroke patients.
Exergames (interactive (cognitive) games which are played by body movements) are an excellent tool for the delivery of simultaneous-incorporated cognitive-motor training and they have already been used in the context of several frail and neurologic populations, including stroke patients.
Proprioception is used to stabilize the body by sensing its position in space via the sense of joint and limb positioning. Proprioception training addresses the balance and somatosensory stimulation and can therefore build a possible prevention strategy for further falls and of managing ADLs. Combining proprioceptive training with simultaneous cognitive tasks could have additional positive outcomes in stroke rehabilitation. Indeed, a recent systematic review concluded that proprioceptive and dual-task exercises stimulate and promote postural balance, gait, and quality of life and reduce the risk of falls in stroke patients compared with traditional rehabilitation programs.
There is currently just one study that has looked into the effects of exergame-based cognitive-motor training with the additional proprioceptive stimulation (by playing the exergames on a labile platform). They found that compared to the training on a stable platform and to a passive control group, training on an instable platform is more effective for the improvement of reactive balance and functional mobility under dual-task conditions in healthy, community-dwelling older adults. The feasibility and effects of this type of training (exergame training on labile surface and thus rich in proprioceptive stimulation) in stroke patients remains unknown.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescription for inpatient rehabilitation due to a stroke
- •Ability to provide a signed informed consent
- •Mini-Mental State Examination (MMSE) score ≥ 20
- •Physically able to stand for at least 3 minutes without external support (self-report)
排除标准
- •Insufficient knowledge of the German language to understand the instructions and the games
- •Conservatively treated osteoporotic fractures in the last 16 weeks
- •Depending on assistance for ambulation (Functional Ambulation Categories <2),
- •Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities which impair the ability to play the exergames and/or conduct the pre-/post assessments
结局指标
主要结局
Adherence rate
时间窗: through study completion, an average of 6 months (over all training sessions)]
Number of attended training sessions as percentages of total possible training sessions
User experience
时间窗: The User Experience questions is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
Several questions specifically tailored to this study regarding perceived safety, perceived positive effects, intention to recommend etc. will be used. Most questions will have a 7step Likert Scale answers. However, there will also be two open ended questions asking for any positive/negative feedback and other general remarks by the participants.
Training Goals
时间窗: The GAS will be defined at T1 (baseline) and will be reevaluated in the middle (after 8 trainings) and T2 (post assessments), through study completion (about 6 months)
Personal goals regarding rehabilitation/training will be assessed with the Goal Attainment Scale (GAS). The GAS is an individual approach to defining and evaluating personal rehabilitation goals. The scale consists of a five-point rating of the achievement of the specified goals. A score of 0 corresponds to the expected improvement or achievement of the predefined goal. A negative score of -1 or -2 is considered worse than expected. A positive score of 1 and 2 is given when the goal is achieved even better than expected. Interpersonal scores for the three time-points will be evaluated descriptively for each participant separately.
Attrition rate
时间窗: through study completion, an average of 6 months
Number of Drop-outs as percentages of patients included in the study
Security incidents
时间窗: through study completion, an average of 6 months (over all training sessions)]
Total number of (Serious) Adverse Events (SAE/AE)
Training Load
时间窗: The 2 questions of the Nasa-TLX will be asked after each training session, through study completion (about 6 months). Answers will be presented descriptively for each training session as well as aggregated by averaging values across all training sessions
The NASA-Task Load Index (TLX) is a self-report, multidimensional assessment tool that rates perceived workload in order to assess a task, a system, or other aspects of performance (in this case the exergames). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. Each subscale can be given a score between 0 and 20. A higher score reflects a higher workload. For this study only the 2 subscales "Mental Demand" and "Physical Demand" will be used.
Usability
时间窗: The System Usability Scale is recorded at the end of the training period and as part of the T2 measurements, through study completion (max. 6 months)
Usability will be assessed on basis of the validated German version of the System Usability Scale (SUS-DE). The SUS-DE is assessed in week 6 of the exergame-based intervention. It consists of ten items that are rated on a five-point Likert scale (i.e. ranging from 1 - "strongly disagree" to 5 - "strongly agree"). A total score will be calculated according to the scoring guidelines of the SUS. The total SUS score ranges between 0 and 100, whereas higher scores indicate better usability. A total SUS score of at least 70 will be considered an "acceptable" solution (i.e. 52 = ok, 73 = good, 85 = excellent, 100 = best imaginable).
Enjoyment
时间窗: The EEQ is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
Enjoyment of the exergame-based intervention concept will be assessed on basis of the Exergame Enjoyment Questionnaire (EEQ) that will be translated to German according to the guidelines for the process of cross-cultural adaptation of self-report measures. It consists of 20 statements corresponding to four categories of questions: (1) immersion, (2) intrinsically rewarding activity, (3) control, and (4) exercise. Each statement will be responded to on a five-point Likert scale (i.e. strongly disagree (1 point), disagree (2 points), neutral (3 points), agree (4 points), and strongly agree (5 points). The EEQ will be analyzed by calculating the average overall score as well as an average score for each category of questions.
次要结局
- Changes in psychomotor speed(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in functional mobility(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in balance confidence(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in cognitive flexibility(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in selective attention(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in gait(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in inhibition and brain activity(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in coordination(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in dynamic balance(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in static balance(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in leg proprioception(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
- Changes in gait confidence(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention)
研究者
Eleftheria Giannouli
Dr.
Swiss Federal Institute of Technology