The Effectiveness of Mental Imagery in Motor and Cognitive Rehabilitation in Subjects of Early Stage of Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change is being assessed (Change from Baseline Balance at 12 weeks)
研究概览
简要总结
The purpose of the present study is to investigate the effectiveness of mental imagery (MI) in subjects with early stage of dementia. The hypothesis of the study is that MI will have a beneficial effect in motor, cognitive and emotional state in this clinical population.
详细描述
Dementia is a disorder that is characterized by a decline in cognition involving one or more cognitive domains (learning and memory, language, executive function, complex attention, perceptual-motor, social cognition). The most common form of dementia in older adults is Alzheimer disease (AD), accounting for 60 to 80 percent of cases.
Mental imagery (MI) is a technique which involves envisioning motor actions without actual execution. MI is considered an effective rehabilitative tool in athletes, Parkinson's disease, and post stroke because it engages the same or similar neural systems as the actual execution of motor actions to improve gait, gait-related, and cognitive functions having as a result improvements in gait speed, stride length, tandem stance, timed up and go, clock drawing and stroop interference.
The recruitment of the population will be carried out by Day Care Centers in Athens Alzheimer Association. A group of elderly patients with early stage of dementia, aged 65 to 95 years, will participate. Information sheet and consent form will be provided to all participants. A randomized intervention study is designed to assess the efficacy of MI as therapeutic strategy for subjects with early stage of dementia and the sample will be randomized to one of the three following study groups: 1. MI and exercise program (intervention group) 2. Only exercise program (control group) 3. Neither MI nor exercise program (2nd control group). Assessment will be obtained in three-time periods: prior to the program, middle of the program and after the program.
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
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* 95 years\65 years
- •* Diagnosed early stage of dementia
- •* Good oral and written speech and to perform orders
- •* Both sexes
- •* Ambulatory
- •* No other health issues in the last month
排除标准
- •Late stage of dementia
- •Psychiatric problems
- •Serious health problems
- •Not able to walk
研究组 & 干预措施
Mental imagery (MI) and exercise program
MI will start immediately when the sample is going to start the exercise program. The intervention group will undergo 24 sessions of imagery, starting from the 1st exercise program session. Participants of the intervention group will undergo a 45-minute imagery session sitting in a quiet place after the end of every exercise program session. The content of every imagery session is alike with the content of the exercise program session. That means that every session includes imagery of the same exercises of the exercise program performed earlier by the subject in the Day Center. Sessions are identical for all subjects of the intervention group. The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks).
干预措施: Mental imagery (MI) and exercise program (Other)
Mental imagery (MI) and exercise program
MI will start immediately when the sample is going to start the exercise program. The intervention group will undergo 24 sessions of imagery, starting from the 1st exercise program session. Participants of the intervention group will undergo a 45-minute imagery session sitting in a quiet place after the end of every exercise program session. The content of every imagery session is alike with the content of the exercise program session. That means that every session includes imagery of the same exercises of the exercise program performed earlier by the subject in the Day Center. Sessions are identical for all subjects of the intervention group. The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks).
干预措施: Mental Imagery and Exercise program (Device)
Exercise program
The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks).
干预措施: Mental imagery (MI) and exercise program (Other)
结局指标
主要结局
Change is being assessed (Change from Baseline Balance at 12 weeks)
时间窗: Prior to the 1st week of the program, the 12th week of the program
The Berg Balance Scale (BBS) is used to objectively determine a subject's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Change is being assessed (Change from Baseline Functional status at 12 weeks)
时间窗: Prior to the 1st week of the program, the 12th week of the program
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It measures the time that a subject takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Change is being assessed (Change from Baseline Stability at 12 weeks)
时间窗: Prior to the 1st week of the program, the 12th week of the program
The Multidirectional Reach Test (Reach in Four Directions Test) is a screening tool to determine the limits of stability of subjects in 4 directions: forward, backward, leftward and rightward. Subjects performed maximal outstretched arm reach in each direction with their feet flat on the floor.
Change is being assessed (Change from Baseline Siti-to-stand ability at 12weeks)
时间窗: Prior to the 1st week of the program, the 12th week of the program
The Five Times Sit-to-Stand Test (FTSST) is considered to be a useful, consistent and low-cost tool to assess sit-to-stand ability. The FTSST measures the time taken to stand five times from a sitting position as quickly as possible that measures of lower limb strength, balance control and exercise capacity.
次要结局
- Cognitive ability(Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program)
- Depression(Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program)
- Quality of life(Prior to the 6th week of the program, the 6th week of the program, the 12th week of the program)
研究者
Anna Christakou
Principal Investigator
University of West Attica