Effect of Sensory-motor Rehabilitation of the Hand on Cognitive Functions in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Montreal Cognitive Assessment
研究概览
简要总结
Evidence suggests the association between fine motor skills of the hand and cognitive function, as well as the positive effects of hand rehabilitation on hand function and the effectiveness of cognitive rehabilitation on cognitive functions in patients with Parkinson's disease (PD). In response to the question of whether there is a cause-and-effect relationship between fine manual skills and cognitive function, we designed the present randomized controlled trial to investigate the effectiveness of sensory-motor rehabilitation of the hand on cognitive functions compared to the effectiveness of cognitive rehabilitation on sensory-motor skills of the hand in patients with PD.
In this double-blinded, randomized controlled trial, a convenience sample including 48 people with PD will participate based on simple non-random sampling. The participants will be allocated randomly through stratified randomization to parallel groups of intervention (sensorimotor hand rehabilitation) and control (cognitive rehabilitation) with a 1:1 allocation ratio. The associate researcher responsible for assessing outcome measures and the statistician responsible for analyzing the data are blinded to the intervention protocol. The intervention protocol for the intervention group includes hand sensory-motor rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week, in addition to cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. The intervention protocol for the control group includes cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. All participants undergo three assessment sessions: the day before the intervention, the day after the intervention, and one month after the last intervention session. Data will be analyzed using SPSS version 22.0. The significance level will be set at 0.05.
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
- Single (Outcomes Assessor)
盲法说明
Statistician responsible for data analysis
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
- •45-65 years old: age of peak incidence of PD;
- •Minimum 2 years and maximum 10 years from initial diagnosis: stabilization of the disease process and medications;
- •disability level of at most 3 in the Modified Hoehn and Yahr Scale: physically independent;
- •Mild cognitive impairment: score between 20 and 26 in Montreal cognitive assessment;
- •Signing the written informed consent.
排除标准
- •Patients with neurological diseases other than PD
- •Patients with orthopedic and internal diseases that would make participation in the study difficult
研究组 & 干预措施
Hand Sensorimotor Rehabilitation
The intervention protocol includes hand sensory-motor rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week, in addition to cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week.
干预措施: Hand Sensorimotor Rehabilitation (Other)
Cognitive Rehabilitation
The intervention protocol includes cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. The cognitive rehabilitation program will be conducted the same as the cognitive rehabilitation for the intervention group, which was explained in the previous section
干预措施: Hand Sensorimotor Rehabilitation (Other)
Cognitive Rehabilitation
The intervention protocol includes cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. The cognitive rehabilitation program will be conducted the same as the cognitive rehabilitation for the intervention group, which was explained in the previous section
干预措施: Cognitive Remediation (Other)
结局指标
主要结局
Montreal Cognitive Assessment
时间窗: - The day before the intervention - The day after the intervention - One month after the last intervention session
To assess the general cognitive status of the participants. In the scoring of this test, a score of 26 and above indicates normal cognitive function, a score of 25 and below indicates mild cognitive impairment, and a score below 20 means severe cognitive impairment
KING'S PD Pain Scale
时间窗: - The day before staring intervention - The day after ending intervention - one month after ending intervention
this tool measures pain which is specifically designed for patients with PD.
Cambridge Neuropsychological Test Automated Battery - Reaction Time
时间窗: - The day before the intervention - The day after the intervention - One month after the last intervention session
To measure the speed of the participants' response to a visual target in which a predictable (simple reaction time) or unpredictable (choice reaction time) stimulus is presented. The approximate test time is 5 minutes. The response time latency is measured in milliseconds.
Cambridge Neuropsychological Test Automated Battery - Spatial Span Test
时间窗: - The day before the intervention - The day after the intervention - One month after ending intervention
This test examines working and short-term memory. The participants are asked to tap on the squares on the monitor screen as they light up, in the order they appear. The approximate time to complete the test is 5 minutes
Cambridge Neuropsychological Test Automated Battery - Match to Sample Visual Search Test
时间窗: - The day before the intervention - The day after the intervention - One month after the last intervention session
This test measures attention and visual search. In this test, a complex visual pattern is displayed in the middle of the monitor screen. After a short delay, a variable number of similar patterns are displayed in a circle around the edge of the monitor screen.
Cambridge Neuropsychological Test Automated Battery - Stop Signal Task
时间窗: - The day before the intervention - The day after the intervention - One month after the last intervention session
This test measures response inhibition. The test consists of two parts: in the first part, the participant is told to press the left button when they see an arrow pointing to the left direction and the right button when they see an arrow pointing right; In the second part, the participant is told to continue selecting buttons while they see the arrows, but if they hear an audible signal (beep), they must hold their response and not select the button
Box & Block Test
时间窗: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This test assesses hand fine motor skills by moving one-inch wooden cubes from one side of a 5.8 x 4.25 x 7.53 cm box to the other side.
The Purdue Pegboard Test
时间窗: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This test assesses fine motor skills and hand-eye coordination. The assembly subtest will considered in the present study.
Hand Dynamometer Hydraulic Jamar
时间窗: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This tool measures hand grip strength.
Pinch gauge
时间窗: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This tool measures fine fingertip grip strength
Semmes-Weinstein monofilaments
时间窗: - The day before staring intervention - The day after ending intervention - one month after ending intervention
This test assesses the tactile pressure perception threshold
The Michigan Hand Outcome Questionnaire
时间窗: - The day before staring intervention - The day after ending intervention - one month after ending intervention
It measures the individual's own perspective on overall hand function
次要结局
未报告次要终点
研究者
Hamid Reza Rostami
Dr. Hamid Reza Rostami
Isfahan University of Medical Sciences