ISRCTN18436655CompletedUnknown
A pilot study to compare static night time ankle foot orthosis with contracture control device in the management of ankle contractures in ambulant boys with Duchenne muscular dystrophy
ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites5 target enrollmentStarted: February 9, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •primary submission:
- •1. Genetic diagnosis of DMD
- •2. Ankle ROM of between +10 degrees of dorsiflexion and -10 degrees of dorsiflexion.
- •3. On assessment ROM has either deteriorated or remained the same since prior appointment despite good adherence to current stretching regime
- •4. Aged between 4 and 10 years of age
- •5. Orthotic naïve
- •AMENDMENT to inclusion criteria: Re-submission:
- •1. Ankle orthotic naïve or supplied with an AFO in the last 18 months that currently fits well
- •2. From JWMDRC clinics or referred to us by a centre which borders us
- •3. Email or written evidence that the local specialist team are amenable to our oversight of orthotics for the duration of the study
Exclusion Criteria
- •1. Significant behavioural issues that would make adherence problematic
- •2. Previous or current lower limb fracture within the last year
- •3. Previous tenotomy or other interventions for contracture management
- •4. Non-English speaking
Investigators
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