1. To determine the reproducibility and sensitivity of the EC of walking test in boys with DMD, in comparison with the reproducibility and sensitivity of the 6MWT. 2. To evaluate the one-year course of limitations in ambulation among boys with DMD,…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters
-Speed (m/min)
-Net energy cost (J/kg/m)
-6-minute walking distance (m)
Secondary outcome
Secondary study parameters
-Participation in daily activities and social roles
-Intensity of participation
-Perceived exertion
Additional study parameters
-Age (yrs)
-Height (cm)
-Body-mass (kg)
-Leg length (cm)
Background summary
Many boys with Duchenne muscular dystrophy (DMD) describe limitations in
ambulation. The course of these limitations can be measured with the 6-minute
walking test (6MWT) or with the energy cost (EC) of walking test. However,
information on the reproducibility and sensitivity of both these tests in boys
with DMD is unknown, and has never been described in the literature. This lack
of knowledge is a major drawback for choosing the most appropriate functional
measurement tool in clinical trials among boys with DMD.
Study objective
1. To determine the reproducibility and sensitivity of the EC of walking test
in boys with DMD, in comparison with the reproducibility and sensitivity of the
6MWT.
2. To evaluate the one-year course of limitations in ambulation among boys with
DMD, as quantified with the EC of walking test and 6MWT.
Study design
In order to determine the reproducibility of the EC of walking test and the
6MWT in boys with DMD, an intra-rater test-retest reproducibility study will be
conducted at the outpatient clinic of the department of Rehabilitation medicine
in the VU University medical center (VUmc) in Amsterdam.
Study burden and risks
Benefits: this study will show whether the EC of walking test is a more
reproducible and sensitive test than the 6MWT. This information is important
for choosing the most appropriate functional measurement tool that can be used
in studies evaluating the effect of therapies and treatment in boys with DMD.
Risks and burden: the risk for the patients in this study is negligible. Also,
the burden for the patients is low; per visit two sub-maximal walking tests
will be performed (comparable to walking in daily-life), with bouts of (seated)
rest in between the different parts of the experiment.
De Boelenaan 1117
1081HV Amsterdam
NL
De Boelenaan 1117
1081HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
-children diagnosed with Duchenne muscular dystrophy
-children aged between 6 and 14 years
-children capable of walking independently for more than 150m without any supportive devices.
Exclusion criteria
-children who underwent surgery (<6 months ago)
-children who are unable to follow simple instructions;
-children who have behavioural problems that compromise participation in the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29858.029.09 |