|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR2165 |
|
Date of registration:
|
07/01/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Energy cost of walking in boys with Duchenne.
|
|
Scientific title:
|
Energy cost of walking in boys with Duchenne muscular dystrophy; a reproducibility and sensitivity study. -
|
|
Date of first enrolment:
|
1/3/2010 |
|
Target sample size:
|
20 |
|
Recruitment status: |
recruiting |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2165 |
|
Study type:
|
observational |
|
Study design:
|
Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: Single arm
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
M.A.
Brehm |
|
Address:
|
de Boelelaan 1117
1081 HV
Amsterdam
The Netherlands |
|
Telephone:
|
+31 (0)20 4443062 |
|
Email:
|
M.Brehm@vumc.nl; m.a.brehm@amc.uva.nl |
|
Affiliation:
|
|
|
|
Name:
|
M.A.
Brehm |
|
Address:
|
de Boelelaan 1117
1081 HV
Amsterdam
The Netherlands |
|
Telephone:
|
+31 (0)20 4443062 |
|
Email:
|
M.Brehm@vumc.nl; m.a.brehm@amc.uva.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Children aged at least 6 years, and not older than 14;
2. Children diagnosed with duchenne muscular dystrophy;
3. Children capable of walking independently for more than 150m without any supportive devices, and who are likely to be able to continue walking for more than 150m for at least one year.
Exclusion criteria: 1. Children who underwent surgery (<6 months ago);
2. Children who are unable to follow simple instructions;
3. Children who have behavioural problems that compromise participation in the study.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Duchenne muscular dystrophy, preservation of functioning, Energy cost (EC) of walking, Reproducibility
|
|
Primary Outcome(s)
|
1. From the ECWT: speed (m/min), non-dimensional speed (N_speed), net energy cost (EC) (J/kg/m), and net N_EC;
2. From the 6MWT: speed (m/min), N_speed, and the 6-minute walking distance (6MWD) (m).
|
|
Secondary Outcome(s)
|
1. From the Life-Habits: participation in daily activities and social roles;
2. From the Borg scale: the Rating a patient?s Perceived Exertion (RPE score);
3. From the intake and physical examination: age (yrs), height (cm), weight (kg), and leg length (cm);
4. From the Brooke scale: functional capacities.
|
|
Secondary ID(s)
|
|
WC2009-098 / 09/322
|
|
Source(s) of Monetary Support
|
|
Prosensa Therapeutics B.V.
|
|