Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248073
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-07
Brief Title:
Effectiveness of Online Program and Task-related Training for Parkinsons Disease
Sponsor:
Chang Gung University
Organization:
Chang Gung University
Study Overview
Official Title:
Comparing the Effectiveness of Online Self-management Program and On-site Task-related Training for People With Early Stage Parkinsons Disease on Activity Participation and Quality of Life
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons disease
people with early stage of Parkinsons 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 groupThe 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 Parkinsons 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 Parkinsons disease on activity participation and quality of life
people with early stage of Parkinsons 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 groupThe 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 designThe independent variables consist of two factors the first is the between-group factor which is the intervention method control group vsonline 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
Introduction Previous studies have indicated that hand function impairment may be one of the early motor symptoms and precursor markers of Parkinsons 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 Parkinsons 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 designThe independent variables consist of two factors the first is the between-group factor which is the intervention method control group vsonline 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None