Cerebral Palsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Children with cerebral palsy or a related non-progressive disorder between the ages of 4 and 12. - Gross Motor Function Classification System (GMFCS) level I - III. - Parents and/or children have a treatment question related to either walking ability and/or participation of their child.
Exclusion criteria
Exclusion criteria: - Participants that suffer from a progressive neurological disorder. - Treatment with botulinum toxin and/or serial casting in lower extremities planned during the study. - Treatment with botulinum toxin in the 12 weeks prior to the study. - Treatment with serial casting in the 3 weeks prior to the study. - Children that underwent a selective dorsal rhizotomy in the 12 months before participation in the study. - Children that underwent orthopedic surgery on their lower extremities in the 12 months before participation in the study. - Children that have already received MegaPower training in the last 4 months before participation in the study - Children for whom walking is not their preferred method of locomotion (yet).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary research outcome is an improvement in participation and activity, measured through Goal Attainment Scaling (GAS). Using the GAS, patient-tailored goals will be set up and evaluated using a Likert scale with a reach from -3 (decline) to +2 (much more improvement than original goal). Pre-baseline, the children will undergo the mobility questions of the Canadian Outcome Performance Measure (COPM) together with a therapist. The COPM is especially suited to identify and order personal mobility goals on participation and activity level. After identifying these goals, 1-3 GAS-goals will be written down on both participation and activity level. The child will then have to order their goals and choose a primary goal for both participation and activity. All GAS-goals will be (re-)evaluated at t = 12 weeks (end of intervention), t = 24 weeks (halfway follow-up), and t = 36 weeks (end of follow-up). In case a chosen primary goal cannot be accurately measured or defined using the Likert scale, a secondary goal will become the new primary goal. Only the primary goals will be used for statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parent-reported mobility (questionnaires); measured using the Gait Outcomes Assessment List (GOAL) and Mobility Questionnaire (MobQues28). 2. Physical tests for the following paramaters a. Walking speed -> 1-minute walk test b. Aerobic endurance -> 10m shuttle run test c. Anaerobic capacity -> Muscle Power Sprint Test 3. Body composition; measured using bioelectrical impedance analysis (BIA). 4. Dietary intake at baseline (questionnaire); measured using a 3-day food diary in which parents have to track the nutritional intake of their child during 2 week days and 1 weekend day. 5. Physical activity and sleep, measured over a 7-day period using a wrist-wearable accelerometer. 6. Self-perception of the child (questionnaire); measured using Harter's Self-Perception Profile for Children on the domains of social competence, athletic competence, and global self-worth. 7. General baseline characteristics (questionnaire); including: o Age, height, weight, BMI, gender, Gross Motor Function Classification System, CP type, Amsterdam Gait Classification, Selective Control Assessment of Lower Extremities, type of education, education level of their parent(s), use of ankle-foot orthoses. 8. Process evaluation (also see 'aanvullende opmerkingen'). As part of the process evaluation we will also measure parental satisfaction regarding the MegaPower training. | — |
Countries
Netherlands
Contacts
Amsterdam UMC