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Full Speed Ahead: For Joyful Movement and Health

Full Speed Ahead: For Joyful Movement and Health

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07374432
Acronym
fullspeed
Enrollment
20
Registered
2026-01-28
Start date
2024-12-07
Completion date
2026-12-30
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

cerebral palsy, Frame running, early intervention, children, mobility, physical activity

Brief summary

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.

Interventions

BEHAVIORALFull speed ahead

12 weeks of daily training at home and 1 group training session /week including both Frame running and grossmotor training

Sponsors

Karolinska Institutet
Lead SponsorOTHER
Region Stockholm
CollaboratorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Singel subject design with 3 baseline before intervention and 3 follow up after intervention

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

GMFCS II-V

Exclusion criteria

severe intelectual disability

Design outcomes

Primary

MeasureTime frameDescription
Gross Motor Function MEasure (GMFM)From enrollment to the end of treatment at 3 monthMeasure gross motor function in children with CP from 6 month to 18 years, the scale ranging from 0-100 units, higher is better

Secondary

MeasureTime frameDescription
Sens motion, AccelerometryFrom enrollment to the end of intervention at 3 monthsMeasure physical activity in daily life

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026