Clinical trial NCT06248073: Effectiveness of Online Program and Task-related Training for Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Occupational Therapy
Telerehabilitation
Activities of Daily Living
Keywords: Telerehabilitation
early intervention
patient-reported outcome assessment
self-perception
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Purdue Pegboard Test
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Box and Block test
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Proprioceptive sensitivity Assessment
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
Secondary outcomes:
measure: Time up and go test (TUG)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Grip Strength measure
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Pinch Strength measure
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Hand length measure
timeFrame: Baseline (before intervention)
measure: The University of Pennsylvania Smell Inventory Test (UPSIT)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline (before intervention)
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: WHOQOL-bref Taiwan version
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up ( 6 months after intervention)
measure: Home activity log
timeFrame: Within the intervention (6 weeks)
measure: General Self-Efficacy Scale (GSE)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up ( 6 months after intervention)
measure: The unified Parkinson's disease rating scale (UPDRS)
timeFrame: Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
Other outcomes:
measure: Mini-Mental Status Examination (MMSE)
timeFrame: Screening-before intervention (one of the inclusive criteria)
measure: Beck depression scale
timeFrame: Screening-before intervention (one of the inclusive criteria)
Locations:
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Kuan-yi Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: