Contracture management in Duchenne muscular dystrophy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18436655

Enrollment

Registered

2024-02-09

Start date

2021-04-21

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne muscular dystrophy Musculoskeletal Diseases

Interventions

A single-centre, single-blinded, randomised control trial pilot study comparing CCDs and AFOs over 12 weeks of intervention. Once agreeing to take part, each boy is randomly put into a group and asked

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time frame
Feasibility of trial design, measured using attrition rate assessed using the number of participants who consented to participate who remained in the study until the end of follow-up at 12 weeks.	—

Secondary

Measure	Time frame
1. Ankle ROM measured using goniometry at [baseline T1, baseline T2, week 4 T4, week 8 T5 (no week 8 visits following amendment), week 12 end of study T6] 2. Motor function measured using the North Star ambulatory assessment (NSAA) at baseline T1, baseline T2, week 4 T4, week 8 T5 (no week 8 visits following amendment), week 12 end of study T6 3. Satisfaction with service and device measured using the Orthotics and Prosthetics User's Survey (OPUS) at week 2 T3, week 4 T4, week 8 T5 (no week 8 visits following amendment), week 12 end of study T6 4. Adherence to the intervention measured using a daily diary for 12 weeks	—

Measure

Time frame

1. Ankle ROM measured using goniometry at [baseline T1, baseline T2, week 4 T4, week 8 T5 (no week 8 visits following amendment), week 12 end of study T6] 2. Motor function measured using the North Star ambulatory assessment (NSAA) at baseline T1, baseline T2, week 4 T4, week 8 T5 (no week 8 visits following amendment), week 12 end of study T6 3. Satisfaction with service and device measured using the Orthotics and Prosthetics User's Survey (OPUS) at week 2 T3, week 4 T4, week 8 T5 (no week 8 visits following amendment), week 12 end of study T6 4. Adherence to the intervention measured using a daily diary for 12 weeks

—

Countries

England, United Kingdom

Contacts

Public ContactDionne Moat

dionne.moat@newcastle.ac.uk+44 (0)191 2418756

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026