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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
Pathways and Resources for Engagement and Participation (PREP)
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.

Michal Waisman-Nitzan, Dr contact

972-544552728

michalwni@gmail.com

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 groups in NCT06540365
Study groupRoleWhat they receive
Community-Based activity programExperimentalNot 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.

  1. 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.

  1. First posted6 Aug 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

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)
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

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.

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Clinical Trial NCT06540365 | AzTrials