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

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy; Physical Medicine / Rehabilitation - Physiotherapy; Neurological - Other neurological disorders

• Registration Number: ACTRN12617000644369
• Lead Sponsor: Ellen Armstrong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-03
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure (GMFM-66)[Baseline: 1 week prior to starting the intervention (T1) Immediately post training (T2) Follow up - after an 8 week maintenance period (T3) Follow up - after an 8 week maintenance period for wait-list group only (T4)];Gross Motor Function Measure (GMFM-88)[Baseline: 1 week prior to starting the intervention (T1) Immediately post training (T2) Follow up - after an 8 week maintenance period (T3) Follow up - after an 8 week maintenance period for wait-list group only (T4)];GMFM-88 goal sections[Baseline: 1 week prior to starting the intervention (T1) Immediately post training (T2) Follow up - after an 8 week maintenance period (T3) Follow up - after an 8 week maintenance period for wait-list group only (T4)]