Full Speed Ahead: For Joyful Movement and Health

NCT07374432 | Enrolling By Invitation

• 2 other identifiers: Dnr 2024-05809-01Privat donations 3 500 000 SEK
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function MEasure (GMFM)

  Measure gross motor function in children with CP from 6 month to 18 years, the scale ranging from 0-100 units, higher is better

  From enrollment to the end of treatment at 3 month

Secondary Outcomes (1)

• Sens motion, Accelerometry

  From enrollment to the end of intervention at 3 months

Other Outcomes (8)

• Functional mobility scale (FMS)

  From enrollment to the end of treatment at 3 months

• Pediatric Evaluation of the Disability Inventory (PEDI- CAT)

  From enrollment to the end of treatment at 3 month

• Time up and Go (TUG)

  From enrollment to the end of treatment at 3 months

Study Arms (1)

intervention

EXPERIMENTAL

Frame running and gross motor training

Behavioral: Full speed ahead

Interventions

Full speed ahead BEHAVIORAL

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

intervention

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• GMFCS II-V

You may not qualify if:

• severe intelectual disability

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Department of Woman's and Children's health

Stockholm, Sweden

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

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

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 28, 2026
• Study Start: December 7, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-09

Locations

SE (1)