The effects of Functional Electrical Stimulation (FES) cycling, recreational cycling and goal-directed training on functional outcomes and participation in children with cerebral palsy - a randomized controlled trial

Ellen Armstrong0 sites40 target enrollmentMay 3, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 3, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Ellen Armstrong

•This study will include children and adolescents with a confirmed diagnosis of CP who at study entry are/have:
•\*Aged 6\-18 years;
•\*Classified as functioning at GMFCS levels II, III or IV, as these groups are most likely to have functional goals that align with a STS transfer and cycling intervention;
•\*Goals to improve functional mobility, cycling ability or STS, stepping transfers developed in collaboration with the child, parent and therapist;
•\*Adequate range of motion (ROM) in their hips, knees and ankles to complete a full revolution of the RT300 (cycle ergometer) crank arm;
•\*Able to understand and follow instructions for GMFM\-66 testing;
•\*Able to actively engage in up to 45 minutes of physiotherapy;
•\*Able to verbally or non\-verbally communicate pain or discomfort;
•\*Able to attend training, testing and follow\-up sessions at one of our training facilities.

•Exclusion criteria
•\*Unable to remain in a comfortable position to use the cycling equipment for a period of up to 30 minutes;
•\*Hypersensitivity to touch or unable to tolerate electrical stimulation;
•\*Hip displacement that causes severe pain and would prevent the child from participating in a cycling or sit\-to\-stand intervention;
•\*Lower limb joint contracture, severe spasticity or severely reduced ROM that could limit the child’s ability to complete a full cycling revolution;
•\*Surgery, trauma or fractures in the preceding 12 months who do not have medical clearance to participate in the 8 week Activate\-CP intervention;
•\*Orthopaedic surgery or serial casting scheduled during the study period;
•\*Any contraindication for FES, including cardiac demand pacemakers, pregnancy or skin damage that may interfere with electrode placement;
•\*Any children with known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the 8 week cycling intervention;
•\*Uncontrolled seizures or epilepsy.