Department of Woman's and Children's health
Stockholm, Sweden
NCT Number: NCT07374432
The aim of this project is to implement and evaluate the effects of a mobility-focused training program, including the use of running frames, on gross motor function and physical activity levels in children aged 2-5 years with cerebral palsy. The hypothesis is that these children can improve their mobility with or without assistive devices, that the training program will influence their overall activity level, and that it will provide cardiovascular exercise leading to improved fitness and muscle development.
In previous studies, the investigators have observed positive health-related outcomes in older children. Recently, three-wheeled Frame Running bikes designed for very young children have become available; however, no research has been conducted on these devices or their potential effects in toddlers.
In this project, group training sessions will be offered to children aged 2-5 years. Participants will receive mobility and gait training with or without assistive devices, depending on individual needs. The three-wheeled Frame Running bike will be included as one training component, although participants may use other assistive aids as needed. Training is planned as play-based activities together with peers, for one hour per week over a 12-week period, complemented by home-based exercises.
Interested in participating?
Request Info2 year–6 year
All sexes
Interventional
Not applicable
Stockholm, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
GMFCS II-V
Exclusion criteria
severe intelectual disability
12 weeks of daily training at home and 1 group training session /week including both Frame running and grossmotor training
Time frame: From enrollment to the end of treatment at 3 month
Measure gross motor function in children with CP from 6 month to 18 years, the scale ranging from 0-100 units, higher is better
Time frame: From enrollment to the end of intervention at 3 months
Measure physical activity in daily life
Time frame: From enrollment to the end of treatment at 3 months
Measure childrens ability to walk on a 5 graded scale
Time frame: From enrollment to the end of treatment at 3 month
Mobility module measure childrens ability to move in the environment on a 0-100 scale
Time frame: From enrollment to the end of treatment at 3 months
Measure balans in standing and motion, mesaure in seconds
Time frame: From enrollment to the end of treatment at 3 month
Measure individualized goals, based a a 5-graded scale
Time frame: From enrollment to the end of treatment at 3 months
Measure the muscles thickness and form
Time frame: From enrollment to the end of treatment at 3 month
Descrieb the parents engagement in treatment
Time frame: From enrollment to the end of treatment at 3 month
Describe the therapist's assessment of the child's engagement
Time frame: From enrollment to the end of treatment at 3 weeks
Measure the pulse continously during certain period
Karolinska Institutet
Other
Acronym: fullspeed
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