An activity stimulation program improves mobility performance and fitness in children with cerebral palsy.
ID
Bron
Verkorte titel
Aandoening
cerebral palsy, training, physical activity, counseling, children
Ondersteuning
Phelpsstichting
JohannaKinderfonds
Revalidatiefonds
Kinderfonds Adriaanstichting
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Performance of mobility:<br>
1. Physical activity measured by 7-days accelerometry (Stepwatch);<br>
2. Self reported activities (CAPE, AQUA, Functional Mobility Scale).
Achtergrond van het onderzoek
BACKGROUND:
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.
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.
PARTICIPANTS:
A total of 50 ambulatory children (age 7-12 years) with cerebral palsy, GMFCS I-III (walking with or without walking aids).
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 and special schools for disabled children 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). The lifestyle intervention includes home-based mobility training and counselling sessions towards a more active lifestyle. Content of the lifestyle intervention is individually defined.
MEASUREMENTS:
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, questionnaires). Secondary outcomes are fitness, capacity of mobility, participation, quality of life, fatigue and self-concept.
Doel van het onderzoek
An activity stimulation program improves mobility performance and fitness in children with cerebral palsy.
Onderzoeksopzet
1. Pretetst at baseline;
2. Fitness tests at 4 months;
3. Fitness and physical activity at 6 months;
4. Follow-up measurement at 12 months.
Onderzoeksproduct en/of interventie
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.
An activity stimulation program consisting of:
1. Physical group training (4 months), and parallel;
2. A tailored life style intervention (6 months).
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age 7 to 12 years;
2. Diagnosis spastic cerebral palsy based on published diagnostic criteria (2);
3. Able to walk with or without assistive devices, that means, class I to III on the GMFCS.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. If they underwent surgery (<6 months ago) or botuline toxine treatment (<3 months ago);
2. If they have cardiovascular contraindications or other medical conditions that may interfere with physical training;
3. If they are unable to follow simple instructions;
4. Have behavioural problems that interfere with participating in a group training;
5. Have predominant dyskinetic or atactic movement disorder.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1982 |
| NTR-old | NTR2099 |
| Ander register | METC VUmc : 2009/14 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |