Feasibility of Technology-based Cognitive-motor Training in Rehabilitation: A Pilot-trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- User Experience
研究概览
简要总结
This pilot trial aims to evaluate the feasibility and effectiveness of a technology-based intervention for cognitive-motor training in rehabilitation clinics with geriatric, neurological and cardiac patients.
The primary objective of this pilot study is to evaluate the feasibility of exergame-based cognitive-motor training in in-patient rehabilitation settings.
The secondary objective of this pilot trial is to evaluate the effectiveness of an expanded rehabilitation treatment (combining exergame training with conventional care) on physical and cognitive functioning in different patient groups.
详细描述
This study is a pilot trial with two arms: an intervention group where the conventional treatment during the stay in the in-patient rehabilitation clinic is extended with a technology-based cognitive-motor intervention and a control group following just the conventional treatment. Participants will be randomly allocated to one of the two groups. The selected methods to evaluate the primary and secondary endpoints include quantitative and qualitative measures. This national study will be conducted in Switzerland in a multicentre setup; three rehabilitation clinics are involved as study centres.
The study will include at least 40 patients in each of the rehabilitation clinics involved as study centres (20 patients in the intervention group, 20 patients in the control group), resulting in a total sample size of 120 patients. At clinic entry, patients potentially fulfilling all inclusion criteria will be informed in oral and written about the study and asked if they wish to participate. All interested participants will then be screened for eligibility. The included participants will then undergo a baseline assessment battery and will be subsequently randomly allocated to the intervention or the control group using a block randomization.
Screening as well as baseline measurements (T1-measurements) are conducted within the first two days upon entry at the rehabilitation clinic. T1-measurements will last around 60-70 minutes. One day after T1- measurements, the intervention will begin (for patients in the intervention group). The intervention period will be equal to the length of the stay in the rehabilitation clinic (between 2-3 weeks, according to each cantonal/regional regulations and insurance coverage) and will include short daily training sessions using the Dividat Senso (5x/week à 10-15min), resulting in 10 to 15 training sessions in total. The training sessions will be supervised by a qualified study investigator (carefully observing patients while training and also preventing/aiding in case of adverse events). At the last two days before discharge from the clinic, post-measurements (T2-measurements) will be performed with all (intervention & control) study participants. T2-measurements last around 70-80 minutes.
Intervention group:
The patients allocated to the intervention group will conduct simultaneously combined cognitive- motor training on a technological device providing exergames, the Dividat Senso. Both, the hardware (Dividat Senso) and the software (exergames) are specifically developed considering the needs and requirements of older adults but also clinicians/therapists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients with prescription for rehabilitation*
- •≥ 50 years old
- •Able to score ≥ 20 at the Mini Mental State Examination (MMSE)
- •Able to provide a signed informed consent
- •Physically able to stand for at least 3min without external support (self-report)
排除标准
- •Mobility or cognitive limitations or comorbidities which impair the ability to use the training games and overall system
- •Conservatively treated osteoporotic fractures
- •Previous or current major psychiatric illness (e.g. schizophrenia, bipolar disorder, recurrent major depression episodes)
- •History of drugs or alcohol abuse
- •Terminal illness
- •Severe sensory impairments (mainly visual, auditory, color blindness)
- •Insufficient knowledge of German to understand the instructions/games
- •*In the rehabilitation clinics involved as study centres, mainly persons suffering from cardiovascular diseases (clinic Seewis), persons suffering from neurological diseases (esp. Parkinson's Disease according to the United Kingdom Brain Bank criteria) (clinic Zihlschlacht) and geriatric patients (clinic Dussnang) will be included in this study.
结局指标
主要结局
User Experience
时间窗: The questionnaire is completed at the post-measurement by the intervention group. The survey lasts 2 minutes.
A questionnaire with (self-developed) questions regarding perceived enjoyment during training, perceived positive effects, intention to use after study's end etc. will be filled out by the intervention group
Training motivation
时间窗: The question is assessed before each training session during the intervention period, an average of 3-4 weeks..
Average training motivation based on motivation question in each session (Scale 1-5) answered by patients.
Attrition rate
时间窗: The attrition rate is assessed during the data collection period, an average of 3-4 weeks.
Number of participants lost during the trial will be recorded (drop-outs in both groups)
Adherence rate
时间窗: The adherence rate is assessed for all training sessions during the intervention period, an average of 3-4 weeks.
Percentage of the number of attended training sessions in relation to the number of planned training sessions
Adverse Events
时间窗: Adverse events are assessed during the data collection period, an average of 3 to 4 weeks.
Related and un-related adverse events during the pre-post assessments as well as during each training session will be registered
System Usability Scale (SUS)
时间窗: The SUS is completed at the post-measurement by the intervention group. The survey lasts 2 minutes.
Participants of the intervention group will receive a survey form at the end of the intervention period regarding usability of the device used for the delivery of the exergame training (Dividat Senso)
Nasa Task Load Index (NASA-TLX)
时间窗: The NASA-TLX is assessed after each training sessions during the intervention period. The survey lasts 1-2 minutes.
The NASA-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 DIVIDAT exergames). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. A score from 1-100 is calculated based by averaging all answers to all questions.
次要结局
- Changes in psychomotor speed(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The 6-RTT lasts 5 minutes.)
- Changes in physical performance(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The SPPB lasts 5 minutes.)
- Changes in inhibitory control(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The test lasts 10 minutes.)
- Changes in Single-Task Walking(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The Single-Task Walk lasts 3 minutes.)
- Changes in mental flexibility(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The TMT lasts ca. 10 minutes.)
- Changes in functional mobility(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The TUG lasts 2 minutes.)
- Changes in Dual-Task Walking(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The Dual-Task Walk lasts 3 minutes.)
- Changes in selective attention(Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The Go/No-Go lasts 5 minutes.)
研究者
Eling DeBruin
Prof. Dr.
Swiss Federal Institute of Technology