Full Speed Ahead: For Joyful Movement and Health (fullspeed)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Full speed ahead

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Department of Woman's and Children's health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

GMFCS II-V

Exclusion Criteria:

severe intelectual disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; Frame running and gross motor training	Behavioral: Full speed ahead; 12 weeks of daily training at home and 1 group training session /week including both Frame running and grossmotor training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sens motion, Accelerometry	Measure physical activity in daily life	From enrollment to the end of intervention at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional mobility scale (FMS)	Measure childrens ability to walk on a 5 graded scale	From enrollment to the end of treatment at 3 months
Pediatric Evaluation of the Disability Inventory (PEDI- CAT)	Mobility module measure childrens ability to move in the environment on a 0-100 scale	From enrollment to the end of treatment at 3 month
Time up and Go (TUG)	Measure balans in standing and motion, mesaure in seconds	From enrollment to the end of treatment at 3 months
Goal Attainment scale (GAS)	Measure individualized goals, based a a 5-graded scale	From enrollment to the end of treatment at 3 month
Ultra sound	Measure the muscles thickness and form	From enrollment to the end of treatment at 3 months
Pediatrice Rehabilitation Intervention Measure of Engagement for Parents (Prime P)	Descrieb the parents engagement in treatment	From enrollment to the end of treatment at 3 month
Service Provider-Rated Measure of Client Engagement (Prime SP)	Describe the therapist's assessment of the child's engagement	From enrollment to the end of treatment at 3 month
Wrist-worn heart rate monitor	Measure the pulse continously during certain period	From enrollment to the end of treatment at 3 weeks

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; children; mobility; early intervention; cerebral palsy; Frame running
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Behavior; Cerebral Palsy; Motor Activity
• Other Study ID Numbers: Dnr 2024-05809-01; Privat donations 3 500 000 SEK (Other Identifier: Karolinska Institutet)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Patient data and we need to know more about the result

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No