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

Chang Gung University

Status: Enrolling

Conditions: Telerehabilitation; Occupational Therapy; Parkinson Disease; Activities of Daily Living

Treatments: Behavioral: onsite task-related training; Behavioral: on-line self-management training

Study type: Interventional

Funder types: Other

Identifiers

NCT06248073

202202160B0C601

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willingness to sign the informed consent form.
2. Age between 45 and 70 years, with mild idiopathic Parkinson's disease and Hoehn and Yahr stage 1-2.
3. No cognitive impairment.
4. No severe depression that could affect the motivation to participate in the study.
5. No history of shoulder dislocation or fracture that could affect body proprioception.
6. No diseases that could affect the ability to reach for objects, such as stroke.
7. No diseases that could affect peripheral sensation, such as diabetes.
8. 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.
9. Able to follow instructions and complete the assessment process.
10. Have not received physical or occupational therapy in the past year.

Exclusion criteria

1. Other central nervous system diseases, such as stroke.
2. Have major surgery on the head or upper limbs.
3. Inability to perform the reaching task while sitting.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

on-line self-management group

Experimental group

Description:

The investigators plan to conduct 12 sessions of intervention, one hour per session, 2 sessions per week, for a total of 6 weeks. Participants will receive interventions in their home via online meetings with a certified occupational therapist. The training will be related to functional tasks in daily life. In addition, the investigators will guide participants to use self-management skills in their daily routines. Participants will receive booklets to conduct their self-practice and exercise for 30 minutes per session, two sessions per week, for a total of 6 weeks.

Treatment:

Behavioral: on-line self-management training

on-site task-related group

Experimental group

Description:

The investigators plan to conduct 12 sessions of intervention, one hour per session, 2 sessions per week, for a total of 6 weeks. Participants will receive interventions at Chang Gung Memorial Hospital. A certified occupational therapist will conduct the interventions. The training will include motor function of upper extremities, balance training and functional tasks. The level of difficulty of the tasks will be adjusted based on the participants' abilities.

Treatment:

Behavioral: onsite task-related training

control group

No Intervention group

Description:

To compare the two experimental groups in the context of early Parkinson's disease, the control group will not receive any additional intervention and will continue their regular daily activities without changes.