Effectiveness of Online Program and Task-related Training for Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: on-line self-management training, onsite task-related training.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Occupational Therapy, Telerehabilitation, Activities of Daily Living. Basic parameters: 45 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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: 1. 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). 2. 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.
Detailed description
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).
Interventions
- Behavioral on-line self-management training
To encourage adherence to the home program among early-stage Parkinson's disease participants, the investigators have developed various self-management topics, including medication adherence and exercise benefits. The home program is categorized into two dimensions: daily function and exercise. The investigators will provides participants with detailed guidelines to ensure safe execution of the program independently. - Behavioral onsite task-related training
Participants will receive interventions at Chang Gung Memorial Hospital. A certified occupational therapist will conduct the interventions. These sessions will involve functional tasks tailored to each participant's skill level, with two to four varied tasks per session. Additionally, participants will be given booklets to guide them in self-managing similar exercises at home, mirroring the home program of the self-management group.
Primary outcome measures
- Purdue Pegboard Test [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Box and Block test [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Proprioceptive sensitivity Assessment [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Nottingham Extended Activities of Daily Living Scale (NEADL) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Parkinson's Disease Questionnaire (PDQ-39) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
Secondary outcome measures (12)
- Time up and go test (TUG) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Grip Strength measure [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Pinch Strength measure [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Hand length measure [Time frame: Baseline (before intervention)]
- The University of Pennsylvania Smell Inventory Test (UPSIT) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Montreal Cognitive Assessment (MoCA) [Time frame: Baseline (before intervention)]
- International Physical Activity Questionnaire (IPAQ) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- The Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- WHOQOL-bref Taiwan version [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)]
- Multidimensional Fatigue Inventory (MFI) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up ( 6 months after intervention)]
- Home activity log [Time frame: Within the intervention (6 weeks)]
- General Self-Efficacy Scale (GSE) [Time frame: Baseline (before intervention), week 6 (after intervention), follow-up ( 6 months after intervention)]
Eligibility criteria
Inclusion criteria
- Willingness to sign the informed consent form.
- Age between 45 and 70 years, with mild idiopathic Parkinson's disease and Hoehn and Yahr stage 1-2.
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Chang Gung Memorial Hospital — Linkou District
Identifiers
NCT: NCT06248073 · 202202160B0C601