To determine whether 3D arm training with arm-support is effective in delaying the loss of arm functions in daily activities from an early age onwards in boys with DMD.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the Motor Function Measure (MFM).
Secondary outcome
Secondary outcomes will be: the Abilhand, joint range of motion (ROM), muscle
echo intensity (EI), lab-based structured 3D movement analysis combined with
surface electromyography (sEMG), accelerometry, a quality of life questionnaire
and the Performance of the upper limb for DMD (PUL).
Background summary
Boys with Duchenne Muscular Dystrophy (DMD) lose their independency for several
activities of daily life (ADL) soon after the onset of wheelchair-dependency
due to muscle weakness of the upper extremity. Nowadays, there are promising
modern arm-supports becoming available that re-enable patients with proximal
arm weakness to functional use their arms by providing external mechanical
compensation for muscle weakness of upper arm and shoulder. However, to make
optimal use of these modern arm-supports patients should maintain joint
mobility and muscle elasticity. Results from previous pilot studies indicate
that assisted functional arm-training can delay the secondary functional
deterioration caused by disuse. A three-dimensional (3D) training of both arms,
starting at an early age, to maintain arm function could even be more useful
but this has not been investigated yet.
Study objective
To determine whether 3D arm training with arm-support is effective in delaying
the loss of arm functions in daily activities from an early age onwards in boys
with DMD.
Study design
Explorative Randomized Controlled Trial (RCT)
Intervention
Boys in the intervention group will receive an assisted 3D arm training for 24
weeks. They will train both arms during 15-min sessions for 5 days per week at
home. Training will consist of a virtual reality game that stimulates the boys
to use their arms in three directions while using an arm-support. The control
group will receive the same intervention after their waiting list period.
Study burden and risks
Burden associated with participation will be limited, since measurements are
non-invasive and the risk of overexertion is limited as the training-intensity
will be relatively low. Signs of overexertion (excessive muscle pain during the
training, prolonged post-exercise muscle pain, a severely uncomfortable feeling
during or after the training, and (extreme) fatigue) will also be investigated
by a postal questionnaire once every two weeks, and in the case of overexertion
training will be adjusted. In addition, from previous studies it is expected
that the interventions are beneficial and may help to preserve functional
abilities for a longer period.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41708.091.12 |
| OMON | NL-OMON27200 |