Duchenne Muscular DystrophyNCT06540365
Applying the Pathways and Resources for Engagement and Participation Protocol Among People With Muscles Dystrophies
A study testing Pathways and Resources for Engagement and Participation (PREP) in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy, run by University of Haifa.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 30 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
- What is being tested?
- Pathways and Resources for Engagement and Participation (PREP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with DBMD
- aged 14-30 years
- from any sector of Israeli society.
Who cannot join
- have previously received the PREP intervention
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed description
Duchenne-Becker muscular dystrophy (DBMD) is an X-linked recessive disorder affecting 1 in 5,000 to 1 in 6,000 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 (e.g., 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.
- Being tested
- Pathways and Resources for Engagement and Participation (PREP)
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways and Resources for Engagement and Participation (PREP)Behavioural
Each participant will work individually with an occupational therapist (OT) to pursue one leisure-oriented, community-based activity chosen by the young person. The participant will choose the community program using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward). The OT will then search for the appropriate program, identify and remove potential environmental barriers to participation in that activity (e.g., accessibility, equipment), and educate program instructors regarding the person's specific needs. This process will include an expected 8 sessions lasting 12 to 18 weeks (depending on the assigned baseline length).
| Study group | Role | What they receive |
|---|---|---|
| Community-Based activity program | Experimental | Not described Receives: Behavioral: Pathways and Resources for Engagement and Participation (PREP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
A gold-standard 10-point scale that measures activity performance and satisfaction. The score ranges from 1 (unable to perform) to 10 (performs extremely well)
Measured: Up to 18 weeks (once a week, during base-line and intervention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Principal investigator, Michal Waisman Nitzan, University of Haifa
- Investigators
- Michal Waisman-Nitzan, Dr, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540365
- Sponsor's protocol ID
- DBMD PREP Intervention
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06540365
- Acronym / sponsor ID
- DBMD PREP Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Duchenne-Becker muscular dystrophy (DBMD) is an X-linked recessive disorder affecting 1 in 5,000 to 1 in 6,000 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 (e.g., 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-Based activity program | Experimental | Behavioral: Pathways and Resources for Engagement and Participation (PREP) |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosed with DBMD
- aged 14-30 years
- from any sector of Israeli society.
Key exclusion criteria (1 listed)
- have previously received the PREP intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathways and Resources for Engagement and Participation (PREP)Each participant will work individually with an occupational therapist (OT) to pursue one leisure-oriented, community-based activity chosen by the young person. The participant will choose the community program using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward). The OT will then search for the appropriate program, identify and remove potential environmental barriers to participation in that activity (e.g., accessibility, equipment), and educate program instructors regarding the person's specific needs. This process will include an expected 8 sessions lasting 12 to 18 weeks (depending on the assigned baseline length). | Behavioural | Community-Based activity program |
Primary outcome
Canadian Occupational Performance Measure
Time frame: Up to 18 weeks (once a week, during base-line and intervention phase)
A gold-standard 10-point scale that measures activity performance and satisfaction. The score ranges from 1 (unable to perform) to 10 (performs extremely well)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Waisman-Nitzan, Dr principal investigator
University of Haifa
Questions about this trial
What is this clinical trial studying?
A study testing Pathways and Resources for Engagement and Participation (PREP) in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy, run by University of Haifa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Waisman-Nitzan, Dr (972-544552728, michalwni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: Up to 18 weeks (once a week, during base-line and intervention phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.