None listed
Conditions
Brief summary
The broad aim of this multi-site, randomised wait-list controlled trial is to determine the effectiveness of the 8-week program of FES-cycling and functional sit to stand (STS) training (2 x per week) and a home exercise program (1 x per week) of recreational cycling and STS training, to improve gross motor function, perceived performance and satisfaction of transfer-related occupational tasks (COPM) and cycling performance in 40 children with moderate CP (GMFCS levels II-IV). Secondary aims are to determine the effects of the intervention on STS and activity capacity; participation at home, school and in the community; and habitual physical activity levels. A qualitative evaluation will independently examine engagement of children/adolescents and their families in the program. This randomised wait-list controlled trial of 40 children with CP will compare an immediate intervention group, to a waitlist group, who will continue to receive usual care then receive the training program. Children/youth with CP who are/have: aged 8-18 years; functioning at GMFCS levels II, III or IV; goals to improve cycling ability or STS transfers; adequate range of motion (ROM) in the lower limbs to cycle will be recruited. Activate-CP will consist of 3 x 60 minute training sessions per week for 8 weeks (24 hours over 24 sessions). Two sessions will be FES-C and STS training. The third session will be completed at home including the STS training and recreational cycling. All FES-C training will be completed on an RT300-SLSA cycle (Restorative Therapies Inc.) designed for users to cycle while sitting in their own wheelchair. FES-electrodes will be applied to both quadriceps, hamstrings, gluteal, gastrocnemius and tibialis anterior muscles as tolerated, A global starting frequency of 40-50Hz will be applied and pulse-width and amplitude will be adjusted based on participant's tolerance. Participants will undertake STS transfers at home and at school to gain context-specific practice. Adapted and recumbent tricycles will be customized to meet individual needs for use at home and in the community. The primary outcome is the Gross Motor Function Measure where an improvement of more than or equal to 3 points following the 8-week intervention is proposed (T2); along with greater perceived performance and satisfaction ratings (by more than or equal to 2 points) on Canadian Occupational Performance Measure (COPM) and improved cycling performance immediately following the intervention (T2). Secondary outcomes will test their STS transfer capacity (Five times STS test); activity capacity (PEDI-CAT), participation at home, school and in the community (PEM-CY), and 7 day habitual physical activity (HPA) levels.
Interventions
The intervention will be an 8-week program of FES-powered cycling (FES-cycling), goal-directed and task-specific sit-to-stand transfer training and a home-based exercise program for children with CP who use an aid or wheelchair to mobilise.
The program will consist of 3 x 60 minute training sessions per week for 8 weeks (a total of 24 sessions, total dose of 24 hours). Two sessions per week will be conducted by a qualified physiotherapist at the Queensland Paediatric Rehabilitation Service (QPR
The intervention will be an 8-week program of FES-powered cycling (FES-cycling), goal-directed and task-specific sit-to-stand transfer training and a home-based exercise program for children with CP who use an aid or wheelchair to mobilise. The program will consist of 3 x 60 minute training sessions per week for 8 weeks (a total of 24 sessions, total dose of 24 hours). Two sessions per week will be conducted by a qualified physiotherapist at the Queensland Paediatric Rehabilitation Service (QPRS) at the LCCH, or at Griffith University, Gold Coast Campus. The third session each week will be completed as a home or community-based exercise program, supervised by the child’s parent/guardian. Each onsite visit will be broken into 30 minutes of FES-C (detailed below) followed by 30 minutes of goal-directed sit-to-stand (STS) transfer practice using a variety of progressive exercises and transfer tasks. The home exercise program will consist of up to 30 minutes of cycling using an adapted cycle and 30 minutes of goal-directed training. Participants will be able to use their own adapted tricycles/bikes if they have access to one or will be provided one on loan. The adapted cycles and various attachments will depend on the child's functional abilities and needs. Cycles may range from a simple recumbent bike with a backrest, to an upright tricycle with a high back rest, looped handle bars, a lap/trunk strap for support and foot straps to keep the child's feet on the pedals. The treating physiotherapist will attend a home visit prior to the study to assess cycling equipment and arrange necessary adaptations. To ensure adequate recovery time, training days will be separated by at least 24 hours. FES-C training parameters will be as follows: Frequency: 2 x sessions per week for 8 weeks; Intensity: A percentage of maximum speed or power output will be used as training targets when cycling on the RT300 and intensity will be monitored by a pulse oximeter, with the aim to maintain >60% of the peak age-predicted heart rate (or >40% of HRR). Duration: up to 30 mins; Progression: Initially, some participants may need to start with shorter sessions while they become accustomed to FES, before progressing to sessions that are greater than 20 mins. Participants will begin cycling for as long as they can before fatigue (up to a maximum of 30 minutes), with the intention to progressively increase the resistance, cadence and cycling duration and reduce the level of motorized support. FES will be delivered bilaterally via adhesive surface electrodes (as tolerated) to the quadriceps, hamstrings, gluteals, tibialis anterior and gastrocnemius muscles/muscle groups. The stimulation parameters for FES-C will be similar to those used in preliminary feasibility research on adolescents with CP and adjusted based on the participant’s tolerance (1-3). A global starting frequency of 40Hz - 50Hz will be used for all muscle groups. 40Hz is the default frequency on the RT300, however Harrington (2011) found that 50Hz was well tolerated by adolescents with CP (2,3). For smaller muscle groups such as the gluteals and gastrocnemius, a frequency closer to 40Hz may be more feasible. Pulse-width and amplitude will be adjusted based on participant’s tolerance, while ensuring that the overall intensity is sufficient to induce a motor response. Goal-directed training parameters will be as follows: Frequency: 2 sessions x per week for 8 weeks (as per FES-C training); Intensity: 1-3 sets of 6-15 repetitions of each transfer-related task, or 50-85% of 1 rep max; Duration: 30mins (following FES-C); Type: Specific to individual participants and dependent on COPM goals. Examples include practicing transfers from different chair heights (incremented for difficulty by starting from a high chair height to low stool), transferring onto different surfaces (i.e. hard plinth vs a soft couch) or sit to stand practice, incremented for difficulty with weighted backpacks/belts. Activities will be designed to maintain participant motivation and provide enjoyment and sense of achievement. In addition to the prescribed program, participants will be encouraged to increase the frequency of STS transfers at home and at school to consolidate training effects and to participate in recreational cycling beyond the prescribed training dose, if this is a form of physical activity that participants enjoy. Training/treatment fidelity: The treating therapist will be a physiotherapist registered under the Australian Health Practitioner Regulation Agency. The therapist will be trained in the administration of the Gross Motor Functional Measure (GMFM-66) by a senior therapist who is a qualified GMFM assessor. The study therapist will also have completed training in the use of the Canadian Occupational Performance Measure and the RT300 cycle ergometer in addition to attending multiple workshops and demonstrations run by an experienced physiotherapist. To maximize participant’s engagement in the home program, the treating physiotherapist will have appropriate knowledge of adapted cycling equipment/community funding for equipment. Treatment fidelity will be monitored by: Video recording training sessions (with parent/caregiver consent); having one therapist conduct all sessions to ensure consistency; having participants complete training/usual care logs to track the home exercise training dose in addition to other training or therapeutic activities completed throughout the study. Due to the nature of the goal-based STS training, the content of the STS program may differ between participants, although efforts will be made to ensure a similar exercise dose. 1. Trevisi E, Gualdi S, De Conti C, Salghetti A, Martinuzzi A, Pedrocchi A, et al. Cycling induced by functional electrical stimulation in children affected by cerebral palsy: case report. European journal of physical and rehabilitation medicine 2012;48(1):135. 2. Harrington AT. The development of a functional electrical stimulation assisted cycling intervention to increase fitness and strength in children with cerebral palsy [Ph.D.]. Ann Arbor: University of Delaware; 2011. 3. Harrington AT, McRae CG, Lee SC. Evaluation of functional electrical stimulation to assist cycling in four adolescents with spastic cerebral palsy. International journal of pediatrics. 2012:1-11. 4. McRae C, Johnston T, Lauer R, Tokay A, Lee S, Hunt K. Cycling for children with neuromuscular impairments using electrical stimulation—Development of tricycle-based systems. Medical Engineering and Physics. 2009;31(6): 650-9.
Sponsors
Ellen Armstrong
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Outcome results
None listed