Metformin for Motor and Cognitive Improvement in Children With Cerebral Palsy: A Feasibility Study
Last updated on July 2021Recruitment
- 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