Clinical trial Recruiting at 1 site Observational Ages 1 Year to 3 Men only

Remote monitoring approach to track movement in young boys with Duchenne muscular dystrophy

Official title: TODDLER Study: Transforming Outcomes in Duchenne Muscular Dystrophy Using DigitaL Endpoints Remotely

Run by University of Oxford · NCT07423026 · Data updated 2026-11-12

A remote, watch-based method is being tested to see if it can accurately track how boys with Duchenne muscular dystrophy move, especially for ages 1-3.

More Duchenne Muscular Dystrophy (DMD) trials

Quick facts

Study typeObservational
Ages1 Year to 3 Years
SexMen only
Enrollment60 (estimated)
SponsorUniversity of Oxford
Academic / other
Locations1 site (Oxford)
StatusRecruiting
StartedJune 24, 2026
Main results expectedOctober 1, 2027
Study endsJuly 1, 2028
Registry record updatedJune 10, 2026
Trial IDNCT07423026 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are boys aged 1-3 with genetically confirmed DMD who can walk 10 meters independently, along with a consenting parent/guardian.

Probably not a fit

Children with DMD who are non-ambulant, have recent limb surgery, or have other conditions affecting movement may see limited benefit from this measurement approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores a new remote testing approach using ankle-worn devices to measure movement in very young boys with Duchenne muscular dystrophy. It focuses on toddlers who cannot easily complete traditional motor tests, aiming to capture reliable movement data outside clinic visits. The study is led by the University of Oxford and compares children with DMD to healthy controls to understand baseline motion and disease-related changes. It does not specify a treatment, but seeks to improve how outcomes are measured in early-stage research and future trials.

Why it matters

Potential benefit: If successful, the wearable approach could provide a convenient way to monitor disease progression and response to therapies in very young children.

How similar studies have gone: Prior research suggests wearable movement sensors can capture meaningful motor data, but use in very young children with DMD is exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Participant with DMD:

* Male
* Aged 1-3 years old
* Ambulant (walking 10m independently)
* Genetically confirmed diagnosis of DMD
* Parent(s)/legal guardian(s) able and willing to provide written informed consent for the child to participate in the study
* Parent(s)/legal guardian(s) able and willing to participate in the study

Parent/legal guardian of participant with DMD:

* Aged 18 years or more
* Legal carer of the patient diagnosed with DMD
* Willingness to follow study procedures and assist with remote assessments, as assessed by the research team
* Willingness to sign the consent form
* Ability to understand all the information with regards to the study, as assessed by the research team

Healthy Control participant:

* Male
* Aged 1-3 years old
* Ambulant (walking 10m independently)
* Parent(s)/legal guardian

Exclusion Criteria:

Participant with DMD:

* Limb surgery/trauma (within 6 months)
* Significant comorbid chronic or acute conditions affecting motor function (within 3 weeks)
* Prematurity (born \<37 weeks' gestation)
* Oral corticosteroids to treat DMD (before enrolment)
* Enrolment in therapeutic clinical trials
* Any comorbidity which could limit their ability to complete the study assessments (according to the investigator's clinical judgement)

Healthy Control participant:

* Limb surgery/trauma (within 6 months)
* Significant comorbid chronic condition affecting motor function
* Significant acute condition affecting motor function (within 3weeks of enrolment)
* Prematurity (born \<37 weeks' gestation)
* Neurodevelopmental concerns or delay in acquisition of WHO developmental milestones.
* Any comorbidity which could limit their ability to complete the study assessments (according to the investigator's clinical judgement).

Where it's running

  • Oxford University
    Oxford, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.