The aim of the study is to evaluate the effectiveness of an activity stimulation program on performance of mobility and lifestyle in children with cerebral palsy, in comparison with regular paediatric physiotherapy.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the intervention, measurements will be performed directly before
randomization, after four months, after six months (end of intervention) and
after one year (six-months follow-up).
Primary outcomes are performance of mobility (StepWatch activity monitor +
activity diary, activity questionnaire[AQUA, FMS]), sports participation
(CAPE), intention towards physically active lifestyle (stage of change).
Secondary outcome
Fitness(submaximal and maximal cycle test, Wingate sprinttest on a stationary
bicycle, muscle strength measured with handheld dynamometry)
Capacity of mobility (sit-to-stand, attaining stand from half kneel stand,
lateral step up test, 1 minute walktest, GMFM domain D,E [standing, walking,
running])
Social participation (Life-Habits kids)
Health-related quality of life (CP-QOL and fatigue scale [MFS])
Self-concept (SPPC)
Background summary
Children with CP show reduced levels of physical activity compared to typically
developing peers. Especially in CP children, physical activity is important,
since it may prevent a decrease in mobility and decreases the risk for
secondary complications due to inactivity.
Study objective
The aim of the study is to evaluate the effectiveness of an activity
stimulation program on performance of mobility and lifestyle in children with
cerebral palsy, in comparison with regular paediatric physiotherapy.
Study design
A six-months single blinded randomized controlled clinical trial with a
six-month follow-up will be performed in local centres for paediatric
physiotherapy between June 2009 and October 2011. Participants are randomised
in either the control group or the experimental group. The control group
follows their regular physiotherapy and the experimental group follows the
activity stimulation program.
Intervention
The intervention is an activity stimulation program that consists of: 1)
physical group training (4 months), and parallel, 2) a life style intervention
(6 months). Group training consists of muscle strength, aerobic and anaerobic
exercises. The lifestyle intervention includes home-based mobility training and
counselling sessions towards a more active lifestyle. Content of the lifestyle
intervention is individually defined. Physical group training takes place in
local centres for paediatric physiotherapy. Home-based physiotherapy and
counselling will be offered at home.
Study burden and risks
It is hypothesized that the activity stimulation program increases performance
of mobility in children with CP. Muscle soreness is likely to occur but is
expected to be temporary. Joint complaints are the most likely physical
complaints. Risks are comparable to usual sport and therapy situations.
Boelelaan 1118
Amsterdam 1007 MB
NL
Boelelaan 1118
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
Spastic cerebral palsy
Able to walk with or without assistive device
7-13 years old
Exclusion criteria
Surgery <6 months ago or botuline toxine treatment <3 months ago
Contraindications or other medical conditions that may interfere with physical training
Children who visit secondary school
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 | NL26539.029.09 |