NCT06248073

Effectiveness of Online Program and Task-related Training for Parkinson's Disease

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chang Gung University · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Parkinson Disease
• Occupational Therapy
• Telerehabilitation
• Activities of Daily Living

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2024-02-08
• Last updated: 2026-03-20

Locations

1 site across 1 country: Taiwan