Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cerebral Palsy
  • Cerebral Palsy, Mixed
  • Cerebral Palsy, Spastic
  • Spastic
  • Spastic Cerebral Palsy
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double blinded. Participants and research personnel will remain masked until the completion of all study participants.Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 12 years
Gender
Both males and females

Description

Clinically, children with CP may receive active physiotherapy, and there is support for goal directed physiotherapy with a focus on motor function and active motor learning principles to enhance motor function in children with CP. For this study, the investigators want to do a feasibility study, to ...

Clinically, children with CP may receive active physiotherapy, and there is support for goal directed physiotherapy with a focus on motor function and active motor learning principles to enhance motor function in children with CP. For this study, the investigators want to do a feasibility study, to see if taking the drug metformin for 16 weeks while doing physiotherapy leads to better gross motor function (i.e. controlled body movements) and thinking skills when compared to doing physiotherapy alone. Participants in both groups will receive goal-directed, active physiotherapy twice a week during the same 16 weeks intervention period. This study will be done at two different locations in Toronto 1) Holland Bloorview Kids Rehabilitation Hospital and 2) the Hospital for Sick Children (SickKids). Each participant will be asked to go to both hospitals to do different tests and assessments for the study. Fifty participants with bilateral spastic CP age 5 to 12 with evidence of white matter imaging (WMI) and gross motor function classification system (GMFCS) levels II-V will be recruited for participation. MRI, cognitive testing and questionnaires will be conducted at SickKids where paediatric protocols and processes have been developed.

Tracking Information

NCT #
NCT03710343
Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Darcy Fehlings, MD, MSc Holland Bloorview Kids Rehabilitation Hospital