Arm training in boys with Duchenne Muscular Dystrophy

Phase 2

Recruiting

Conditions: Duchenne
10028396
10028302

Registration Number: NL-OMON37157

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* A DNA-established diagnosis of DMD
* Boys who are ambulant of wheelchair-dependent and:
- can raise arms (at least one arm) above head only by flexing the elbow (shorthning
the circumference of the movement) or using accessory muscles during 10 repetitions, or
- cannot raise hands above head, but can raise an 8-oz glass of water to the mouth, or
- can raise both hands to the mouth, but cannot raise an 8-oz glass of water to the mouth

Exclusion Criteria

* Boys <7 years old
* Boys who are still able to raise both arms 10 times above head without
flexing the elbow or without using accessory muscles
* Other disabling diseases influencing mobility
* Boys with a clinical symptomatic cardiomyopathy
* Boys who cannot bring their hands to the mouth
* Boys who participate in another intervention trial that aims to delay
physical deterioration. In particular patients that already participate in an
Antisense oligonucleotide (AON)-induced exon skipping study, which may
alter the course of the disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the Motor Function Measure (MFM). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be: the Abilhand, joint range of motion (ROM), muscle<br /><br>echo intensity (EI), lab-based structured 3D movement analysis combined with<br /><br>surface electromyography (sEMG), accelerometry, a quality of life questionnaire<br /><br>and the Performance of the upper limb for DMD (PUL). </p><br>