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Enrolling by Invitation

NCT Number: NCT07374432

Full Speed Ahead: For Joyful Movement and Health

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Woman's and Children's health

Stockholm, Sweden

Who can participate

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

Treatment and study plan

Full speed ahead

Behavioral

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

Primary outcomes

  1. Gross Motor Function MEasure (GMFM)

    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

Secondary outcomes

  1. Sens motion, Accelerometry

    Time frame: From enrollment to the end of intervention at 3 months

    Measure physical activity in daily life

Other outcomes

  1. Functional mobility scale (FMS)

    Time frame: From enrollment to the end of treatment at 3 months

    Measure childrens ability to walk on a 5 graded scale

  2. Pediatric Evaluation of the Disability Inventory (PEDI- CAT)

    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

  3. Time up and Go (TUG)

    Time frame: From enrollment to the end of treatment at 3 months

    Measure balans in standing and motion, mesaure in seconds

  4. Goal Attainment scale (GAS)

    Time frame: From enrollment to the end of treatment at 3 month

    Measure individualized goals, based a a 5-graded scale

  5. Ultra sound

    Time frame: From enrollment to the end of treatment at 3 months

    Measure the muscles thickness and form

  6. Pediatrice Rehabilitation Intervention Measure of Engagement for Parents (Prime P)

    Time frame: From enrollment to the end of treatment at 3 month

    Descrieb the parents engagement in treatment

  7. Service Provider-Rated Measure of Client Engagement (Prime SP)

    Time frame: From enrollment to the end of treatment at 3 month

    Describe the therapist's assessment of the child's engagement

  8. Wrist-worn heart rate monitor

    Time frame: From enrollment to the end of treatment at 3 weeks

    Measure the pulse continously during certain period

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Acronym: fullspeed

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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