Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540365
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Applying the Pathways and Resources for Engagement and Participation Protocol Among People With Muscles Dystrophies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Effectiveness of the Pathways and Resources for Engagement and Participation Protocol Among Youth and Young Adults With Duchenne and Becker Muscle Dystrophies- A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Taking part in community activities is essential for health and well-being Yet it is highly restricted for young people with Duchenne and Becker Muscular Dystrophies DBMD especially as they grow into adulthood The Participation Pathways and Resources for Engagement and Participation PREP intervention is designed to help remove barriers in the environment
This study aims to see if the PREP intervention is useful and practical for youth and young adults with DBMD The main question is How useful is the PREP intervention for improving participation in community-based activities chosen by the participants Participants will start the study at different times 4 5 or 6 weeks and work one-on-one with an occupational therapist on a leisure activity of their choice They will have eight sessions over 12 to 18 weeks to work on this activity
They will use the Canadian Occupational Performance Measure COPM every week to track their performance and satisfaction with the chosen activity before during and after the intervention The findings of this study can guide clinicians families and policymakers to select effective approaches that promote the participation of youth and young adults with DBMD in real world activities they choose It can also increase motivation and compliance and reduce the burden on the healthcare system families and people with DBMD themselves
This study aims to see if the PREP intervention is useful and practical for youth and young adults with DBMD The main question is How useful is the PREP intervention for improving participation in community-based activities chosen by the participants Participants will start the study at different times 4 5 or 6 weeks and work one-on-one with an occupational therapist on a leisure activity of their choice They will have eight sessions over 12 to 18 weeks to work on this activity
They will use the Canadian Occupational Performance Measure COPM every week to track their performance and satisfaction with the chosen activity before during and after the intervention The findings of this study can guide clinicians families and policymakers to select effective approaches that promote the participation of youth and young adults with DBMD in real world activities they choose It can also increase motivation and compliance and reduce the burden on the healthcare system families and people with DBMD themselves
Detailed Description:
Duchenne-Becker muscular dystrophy DBMD is an X-linked recessive disorder affecting 1 in 5000 to 1 in 6000 live male births resulting in difficulties with movement and multi-system implications The affected physical abilities deteriorate as the child grows up In many cases the use of a wheelchair is required at around 10 to 12 years of age followed by a deterioration of strength in the upper limbs and cardiac complications During the last decade the average life expectancy of people with DBMD has risen to their forties As participation in self-chosen meaningful activities within the community and society is essential to health and well-being there is a need to address new opportunities for people with DBMD to participate in an independent and fulfilling life Specifically this pilot study will examine the effectiveness of the PREP intervention protocol among youth and young adults with DBMD
A single-subject experimental design with multiple baselines across participants will be used to study the relative effect of the intervention The intervention will be implemented for 6 participants with DBMD aged 14 to 30 and will be introduced at varying times Every two participants will be randomly assigned to 3 baseline lengths 4 5 6 weeks By varying the length of the baseline phase across participants extraneous variables such as maturation and carry-over effects are controlled for Each participant will work individually with an occupational therapist on one participation goal related to leisure-oriented community-based activity chosen by the young person on expected eight sessions throughout 12 to 18 weeks depending on the assigned baseline length The participants will complete the Canadian Occupational Performance Measure weekly through all study phases baseline intervention
For each participation goal a series of data points representing the level of goal performance and satisfaction generated from the COPM will be plotted and analyzed to detect change Visual analysis will be used to identify and compare patterns of change eg level variability and trend between the baseline and intervention phases A statistical analysis will be used to complement visual interpretation Specifically an acceleration line will detect a trend and slope change across intervention phases This method calculates the proportion of data points falling above and below the line If 50 are above the line and 50 below the line this result indicates no treatment effect whereas significantly more observations falling above the line indicate a change in goal performance
The research team comprised of researchers in the field of complex disabilities and transition-aged youth and young adults has partnered with the Little Steps Association for Children with Duchenne and Becker Muscular Dystrophy and is well-positioned to accomplish the study objectives
This study will draw initial conclusions to support effective approaches that promote the participation of youth and young adults with DBMD in real world activities they choose Findings can also suggest implications such approaches can have on increasing motivation and compliance of people with DBMD to intervention and reducing the burden on the healthcare system families and people with DBMD themselves
A single-subject experimental design with multiple baselines across participants will be used to study the relative effect of the intervention The intervention will be implemented for 6 participants with DBMD aged 14 to 30 and will be introduced at varying times Every two participants will be randomly assigned to 3 baseline lengths 4 5 6 weeks By varying the length of the baseline phase across participants extraneous variables such as maturation and carry-over effects are controlled for Each participant will work individually with an occupational therapist on one participation goal related to leisure-oriented community-based activity chosen by the young person on expected eight sessions throughout 12 to 18 weeks depending on the assigned baseline length The participants will complete the Canadian Occupational Performance Measure weekly through all study phases baseline intervention
For each participation goal a series of data points representing the level of goal performance and satisfaction generated from the COPM will be plotted and analyzed to detect change Visual analysis will be used to identify and compare patterns of change eg level variability and trend between the baseline and intervention phases A statistical analysis will be used to complement visual interpretation Specifically an acceleration line will detect a trend and slope change across intervention phases This method calculates the proportion of data points falling above and below the line If 50 are above the line and 50 below the line this result indicates no treatment effect whereas significantly more observations falling above the line indicate a change in goal performance
The research team comprised of researchers in the field of complex disabilities and transition-aged youth and young adults has partnered with the Little Steps Association for Children with Duchenne and Becker Muscular Dystrophy and is well-positioned to accomplish the study objectives
This study will draw initial conclusions to support effective approaches that promote the participation of youth and young adults with DBMD in real world activities they choose Findings can also suggest implications such approaches can have on increasing motivation and compliance of people with DBMD to intervention and reducing the burden on the healthcare system families and people with DBMD themselves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None