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Clinical Trials/NCT07374432
NCT07374432
Enrolling By Invitation
Not Applicable

Full Speed Ahead: For Joyful Movement and Health

Karolinska Institutet1 site in 1 country20 target enrollmentStarted: December 7, 2024Last updated:
InterventionsFull speed ahead

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
20
Locations
1
Primary Endpoint
Gross Motor Function MEasure (GMFM)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • severe intelectual disability

Arms & Interventions

intervention

Experimental

Frame running and gross motor training

Intervention: Full speed ahead (Behavioral)

Outcomes

Primary Outcomes

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

  • Sens motion, Accelerometry(From enrollment to the end of intervention at 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ann-Christin Eliasson

Professor, PhD

Karolinska Institutet

Study Sites (1)

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