临床试验雷达

Goal Attainment (Goal Attainment Scaling)

Goal Attainment Scaling (GAS) is a method used to measure the achievement of individual goals in a structured and quantitative manner. It is commonly used in clinical and educational settings to evaluate progress and outcomes. Each goal is scaled on a six-point scale, ranging from -3 to +2: Goal Attainment Scaling endpoints will be formulated according to SMART-principles to standardize results.

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Mobility Questionnaire 28 (MobQues28)

The MobQues28 is a parent-reported mobility questionnaire used in cerebral palsy research that assesses gait-related function across different domains of the International Classification of Functioning, Disability and Health (ICF) developed for ambulant children with CP.

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Gait Outcomes Assessment List (GOAL)

The GOAL is a parent-reported mobility questionnaire that assesses gait-related function across different domains of the ICF and is developed for ambulant children with CP. The GOAL is a more comprehensive and better standardized version of the MobQues28. However, since our study population is based off expected differences in the MobQues28 (since data for the GOAL on this subject does not exist yet), both questionnaires are included.

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Harter's Self-Perception Profile for Children

Harter's Self-Perception Profile for Children (HSPPC) is a psychological assessment tool designed to measure self-concept in children. Children will be assessed on the domains of social competence, athletic competence, and global self-worth.

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Physical activity (accelerometer)

Physical activity will be measured over a 7-day period using a wearable accelerometer that participants will have to carry for seven days. The accelerometer picks up accelerations of the body and can accurately estimate physical (in)activity accordingly. The accelerometer does not have an interface and does not save any personal data.

Baseline (t = 0 weeks); t = 12 weeks

Sleep (accelerometer)

Sleep will be measured over a 7-day period using a wearable accelerometer that participants will have to carry for seven days. The accelerometer picks up accelerations of the body and can estimate sleep duration and quality. The accelerometer does not have an interface and does not save any personal data.

Baseline (t = 0 weeks); t = 12 weeks

Body composition (bioelectrical impedance analysis)

Body composition; measured using bioelectrical impedance analysis (BIA). BIA is a method to assess body composition based on the resistance of different tissue types against an unnoticeable electric pulse through the body, since fat mass and fat free mass have a different conductivity.

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Walking speed (1-minute walk test)

The 1-minute walk test is a physical test that measures walking speed. The child is asked to walk as quickly as possible around a measured track for a period of one minute. The distance walked within 1 minute is measured and recorded.

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Aerobic endurance (shuttle run test)

The shuttle run test is a physical test that measures aerobic endurance. Children walk or run at a set incremental speed between two markers that are placed ten meters apart. These walks/runs are coordinated by a recorded CD that plays a sound at pre-determined intervals. Children have to keep up with the speed of these intervals and are measured by the level they reached. Different validated tests will be used for children of different GMFCS levels.

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Anaerobic capacity (muscle power sprint test).

The Muscle Power Sprint Test is a physical test that measures anaerobic capacity. Children have to perform a fifteen meter sprint as fast as possible, repeated six times with ten seconds of rest in between. Their score will be presented in mean and peak power (force \* speed).

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Dietary intake (3-day food record)

Dietary intake at baseline; measured using a 3-day food record in which parents have to track the nutritional intake of their child during two week days and one weekend day.

Baseline (t = 0 weeks).

Process evaluation

A process evaluation will be employed to monitor and document program implementation. With this information, the goal is to evaluate to what extend the MegaPower training was implemented as intended in the participating study centers. This allows us to understand the relationship between specific program elements and program outcomes. The framework by Saunders et al., describing five components of process evaluation will be used. The methods proposed contains questionnaires, report and registration forms, interviews, and focus groups. As a part of this process evaluation, parents will also be asked to fill out a questionnaire about whether their child is happy with the care they received.

Through study completion. An average of 2 years.

Age

Age (years and months) at start of study.

Baseline (t = 0 weeks)

Height (cm)

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Weight (kg)

Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Gender (male/female/other)

Baseline (t = 0 weeks)

GMFCS level (I, II, or III)

The mobility and gross motor skills of people with cerebral palsy are categorized into five different levels using a tool called the Gross Motor Function Classification System (GMFCS).

Baseline (t = 0 weeks)

Type of cerebral palsy

Spastic/dyskinetic/ataxic/unilateral/bilateral/hemiplegia/diplegia/quadriplegia/other.

Baseline (t = 0 weeks)

Type of education (regular/special)

Baseline (t = 0 weeks)

Education level of parent(s)

Baseline (t = 0 weeks)

Use of ankle-foot orthoses (yes/no)

Baseline (t = 0 weeks)

Participation in sports

Do the child and the family of the child participate in any sports? And if so, how many times a week?

Baseline (t = 0 weeks)