Comparing the Effectiveness of Online Self-management Program and On-site Task-related Training for People With Early Stage Parkinson's Disease on Activity Participation and Quality of Life
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Parkinson Disease
- 发起方
- Chang Gung University
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Box and Block test
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The goal of this clinical trial is to compare the effectiveness of online self-management program and on-site task-related training for people with early stage Parkinson's disease.
people with early stage of Parkinson's disease (age range: 45-70 years) will be randomly assigned into the following three groups: control group, online self-management program group and on-site task-related training group.The control group will receive no treatment during the experimental period. For the other two groups, participants will receive the intervention twice a week, one hour per session and 12 sessions in total.
The main questions it aims to answer are:
- the potential impact of motor and non-motor symptoms on activity participation and quality of life for people with early stage of Parkinson's disease (PD).
- compare and examine the the effectiveness of online self-management program and on-site task-related training for people with early stage Parkinson's disease on activity participation and quality of life.
详细描述
This study aims to answer two major research questions. First, the investigators will investigate the potential impact of motor and non-motor symptoms on activity participation and quality of life for people with early-stage Parkinson's disease (PD). Second, the investigators will compare and examine the effectiveness of online self-management programs and on-site task-related training for people with early-stage Parkinson's disease on activity participation and quality of life. Introduction: Previous studies have indicated that hand function impairment may be one of the early motor symptoms and precursor markers of Parkinson's disease. Compared to only receiving drug treatment, additional interventions such as exercise training, environmental adjustments, cognitive behavior and self-management can effectively improve the execution of daily activities and improve the quality of life of patients. Method: The investigators plan to recruit 100 participants within three years and randomly assign them to one of the following three groups: control group, online self-management program group, and on-site task-related training group. Participants: People with early-stage Parkinson's disease (age range: 45-70 years). Procedure: The control group will receive no treatment during the experimental period. For the other two groups, participants will receive the intervention twice a week, one hour per session, and 12 sessions in total. The online self-management program will be an individualized self-management program provided remotely by certified occupational therapists. The on-site task-related training program will include balance and exercise, hand function, and functional task training. Outcome measures: The assessment will be performed before intervention, after the completion of intervention, and 6 months after the post-test. Prior to the experiment, the investigatorswill conduct a pretest. Then, the investigators will conduct a post-test (after intervention) to ensure the short-term effects. Follow-up: After six months of completing the post-test, the cases will undergo a second post-test to understand the long-term effects. Statistical analysis: This study will use two-way repeated measured ANOVA design.The independent variables consist of two factors: the first is the between-group factor, which is the intervention method (control group vs.online self-management program group vs. physical task-related training group); the second is the within-group factor, which is time (pretest vs. first post-test vs. second post-test (follow-up).
研究者
入排标准
入选标准
- •Willingness to sign the informed consent form.
- •Age between 45 and 70 years, with mild idiopathic Parkinson's disease and Hoehn and Yahr stage 1-
- •No cognitive impairment.
- •No severe depression that could affect the motivation to participate in the study.
- •No history of shoulder dislocation or fracture that could affect body proprioception.
- •No diseases that could affect the ability to reach for objects, such as stroke.
- •No diseases that could affect peripheral sensation, such as diabetes.
- •No severe tremors; patients whose hands, when relaxed and placed on the apparatus, still exhibit significant tremor interfering with the experiment will not be included.
- •Able to follow instructions and complete the assessment process.
- •Have not received physical or occupational therapy in the past year.
排除标准
- •Other central nervous system diseases, such as stroke.
- •Have major surgery on the head or upper limbs.
- •Inability to perform the reaching task while sitting.
结局指标
主要结局
Box and Block test
时间窗: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
The change from baseline in dexterity will be measured by the number of blocks participants can put to another box as quickly as possible. Box and Block test is a commonly used tool in occupational therapy to assess hand dexterity. The patient is seated and the experimenter sits opposite the patient to confirm the testing process. The patient is asked to perform the test with their dominant hand, picking up one block at a time and crossing the partition with the block, placing it in the empty space on the other side. The faster the better. Before the formal test, the patient is given 15 seconds of practice time. The formal test lasts for 1 minute.
Proprioceptive sensitivity Assessment
时间窗: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
The examiner will use a customized apparatus from the Sensorimotor Control Laboratory at the University of Minnesota to assess position sense motion sense acuity. Participants will be tested on the same-side position matching test and the psychophysical discrimination threshold test. The examiner moves the examinee's testing hand from the starting position to the testing position and then moves the examinee's wrist back to the starting position. The instrument will use an adaptive algorithm to determine whether to give a simpler or more difficult displacement for the next trial based on whether the examinee's answer is correct or not. A total of about 20 tests are required, and the test time is about 10-15 minutes. The instrument will record the position matching error.
Purdue Pegboard Test
时间窗: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
The change from baseline in dexterity will be measured by the number of pegs participants can put into the holes as quickly as possible. The higher the score, the better the hand dexterity. The test consists of four tasks: inserting pegs with the right hand, inserting pegs with the left hand, inserting pegs with both hands, and assembling pegs with both hands. The time taken to complete the test will be recorded.
Parkinson's Disease Questionnaire (PDQ-39)
时间窗: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
This self-administered questionnaire consists of 39 questions assessing the quality of life of individuals with Parkinson's disease across eight dimensions, including mobility, activities of daily living, emotional wellbeing, stigma, cognition, social support, communication, and bodily discomfort. The questions ask participants to rate the difficulty they experienced in various activities during the past month of living with Parkinson's disease. There are five response options for each question: Not at all, Occasionally, Sometimes, Often, and Always or cannot do at all, scored from 0 to 4, respectively. A higher score indicates greater difficulty experienced by the participant.
Nottingham Extended Activities of Daily Living Scale (NEADL)
时间窗: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
This assessment tool is used to measure an individual's capacity for instrumental activities of daily living. Based on the classification of the International Classification of Functioning, Disability, and Health (ICF model), the assessment pertains to the level of activities and participation. It includes a total of 22 items, all of which are activities performed in daily life. Participants are asked to respond based on their actual performance or involvement in these activities over the past few weeks. Each item has four response options for the participant to self-report: can complete independently, can complete independently but with some difficulty, requires assistance from others to complete, and did not perform this activity. Each item is scored on a scale of 0-3, with a total score of 66. The higher the score, the better the patient's ability to perform daily activities of living.
次要结局
- Grip Strength measure(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- Home activity log(Within the intervention (6 weeks))
- Hand length measure(Baseline (before intervention))
- Montreal Cognitive Assessment (MoCA)(Baseline (before intervention))
- Time up and go test (TUG)(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- Multidimensional Fatigue Inventory (MFI)(Baseline (before intervention), week 6 (after intervention), follow-up ( 6 months after intervention))
- WHOQOL-bref Taiwan version(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- Pinch Strength measure(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- The University of Pennsylvania Smell Inventory Test (UPSIT)(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- The unified Parkinson's disease rating scale (UPDRS)(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- International Physical Activity Questionnaire (IPAQ)(Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention))
- General Self-Efficacy Scale (GSE)(Baseline (before intervention), week 6 (after intervention), follow-up ( 6 months after intervention))