CPMovetime: elliptical training in school aged children with cerebral palsy.

INTERVENTION: The efficacy of CP‐Movetime will be evaluated using a single case experimental design (SCED) featuring concurrent, randomised, replication multiple‐baseline design across participants with cerebral palsy, aged between 5 and 17 years with severe motor impairments (i.e. Gross Motor Function Classification System (GMFCS) levels IV and V). The phases will include A and B (where A is the baseline and B is the intervention). The study will be conducted and reported as outlined in the Single Case Reporting Guidelines in Behavioural Interventions (SCRIBE) 2016 statement. According to the TIDieR: Why (rationale, theory and goal of elements of the intervention): Non‐ambulant children with cerebral palsy (CP) experience more sedentary behaviour, spending up to 96% of their waking day sitting. With no evidence‐based interventions available, this can have a devastating impact on health and well‐being. With the current recommendations for physical activity being 3 sessions a week for 8 consecutive weeks, CPMovetime aims to develop new interventions based on this dosage to provide opportunities for meaningful and safe physical activity and reduce sedentary behaviour for better health outcomes in children with cerebral palsy. What (is needed for intervention delivery): An ellipitcal trainer, hoist ‐ to enable partial body weight support over the trainer, heart rate monitor and engagement materials such as adapted visual materials and adapted video games. What (procedures and activities used in the intervention): Each session will by 1 hour in duration and consist of 2, 10 minute sessions on an elliptical trainer. The child or participant will be supported with a harness to enable them to be safely upright with partial body weight support. The elliptical trainer will e CONDITION: cerebral palsy; ; cerebral palsy Neurological ‐ Other neurological disorders Physical Medicine / Rehabilitation ‐ Physiotherapy PRIMARY OUTCOME: Goal Attainment Scale (GAS); The Goal Attainment Scale (GAS) is used to enable individualised goal setting to enables goals other than just walking to be evaluated in a meaningful and relevant way. The GAS is a recommended assessment tool for paediatric rehabilitation research particularly as activity and participation outcome measures as it is sensitive to change[The GAS is a target behaviour that will be measured weekly through the A (baseline) and B (intervention) phase of the trial, with 8 weeks post intervention commencement (end of phase B) being the primary endpoint.] Performance and satisfaction ratings on the Canadian Occupational Performance Measure (COPM); The COPM is a widely used outcome measure for children with CP that identifies performance problems in a top down approach in both clinical practice and research. This measure is client/family centered and is therefore the most suitable measure for activity and participation in this population. The COPM is valid, reliable and responsive to changes following intervention from the patient/family’s perspective. [The COPM is a target behaviour that will be measured weekly through the A (baseline) and B (intervention) phase of the trial, with 8 weeks post intervention commencement (end of phase B) being the primary endpoint.] SECONDARY OUTCOME: Blood test evaluation: lipoproteins. ; ; ; ; ; ; ; ; Real time Ultrasound ; ; ; Gel will be applied to the skin with a generous quantity used to ensure no compression or distortion of the muscle which will affect the quality and reliability of the measure. ; ; The distance between the anterior superior iliac spine and the superior border of the patella will be measured and marked with a pen on the skin (as a horizontal line). ; INCLUSION CRITERIA: Children with cerebral palsy, aged between 5 and 17 years classified within GMFCS levels IV and V. ; Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte‐balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i‐STAT cartridge and using the i‐STAT Blood Gas Analyzer (i‐ STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).[This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Blood test evaluation: triglycerides ; Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte‐balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i‐STAT cartridge and using the i‐STAT Blood Gas Analyzer (i‐ STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).[This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Blood test evaluation: cholesterol. ; The Dual‐energy X‐ray Absorptiometry or DXA scanner will be used to determine bone and body composition. The DXA is suitable for use in this population because of the accuracy in determining body composition as well as regional body composition. Ionizing radition is very small (<10 microSieverts) for a whole body scan and this is equivalent to a normal background radiation received over a single day when at sea level. The scan will however, be conducted by a licensed technologist with established competency and reliability in performing the scans. ; Each participant will be asked to lie on the table and to stay still for as long as possible. For children in this study, a two person transfer will be required (from wheelchair to bed). This will be done with a parent and a therapist on site for the DXA scan positioning. The use of foam blocks and straps will be used to position and support the participant on the table so that they are safe and secure given that this population will not have the postural control to attain and maintain a static position. The scan itself will take up to 5 minutes (dependent on how static the participant is able to remain). Outcomes of interest include bone density (produced by Z scores) as well as fat and lean mass percentages. This is a composite secondary outcome measure. ; Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte‐balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i‐STAT cartridge and using the i‐STAT Blood Gas Analyzer (i‐ STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).[This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Blood test evaluation: glucose ; Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte‐balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i‐STAT cartridge and using the i‐STAT Blood Gas Analyzer (i‐ STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).[This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Body Composition (bone density, lean muscle and body fat percentage). ; [This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] CPCHILD ; The CPCHILD a valid and reliable proxy measure specifically developed for non‐ambulant children with CP to determine changes in functional health status, health related quality of life and caregiver burden. The measure contains 36 items and 7 domains which include (1) personal care/activities of daily living, (2) positioning, transfers and mobility, (3) comfort (includes pain and discomfort) and emotions, (4) communication and social interaction, (5) health, (6) overall quality of life.[This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Energy Expenditure (Metabolic Cart) ; [This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Exit interview: feasibility of intervention ; Expired gases will be measured throughout for the determination of Oxygen consumption (VO2), Carbon dioxide production (VCO2), Minute ventilation (VE), Respiratory Exchange Ratio (RER), tidal volume (Vt) and breathing frequency. Expired will be measured breath‐by‐breath by a TrueOne 2400 metabolic cart (ParvoMedics, Sandy, UT, USA) and averaged every 15 seconds. Expired gasses will be measured throughout the duration of the intervention but averaged over a 2 min period to ensure the participant has reached a physiological steady state. A physiological steady‐state is required to ensure the validity of the calculation, where VO2 is truly representative of the energy expenditure. The physiological steady‐state will be defined as the 2‐min period between 4 and 10 min with an increase of less than 100 mL VO2, RER < 1.0 to assume a negligible anaerobic contribution to energy expenditure. Energy expenditure will be expressed in metabolic equivalents (MET) and kilojoules (kJ). Kilojoules will be calculated based on the KJ equivalent of the VO2 (kJ·L‐1 O2, with a calorie‐to‐kilojoule conversion factor of 4184) determined by the RER using non‐protein respiratory quotient. The gas analyser and ventilometer will be calibrated before each test using gases of known concentrations and a 3‐l syringe (5530 series, Hans Rudolph, Inc., Shawnee, KS, USA). This method of measuring energy expenditure is considered the gold standard non‐invasive method and has been the preferred method documented in the literature. ; A semi‐structured exit interview will occur after the "B" phase (intervention). This will enable the experience of the intervention and elements of feasibility to be described and explored from the perspective of children (if able to participate) and caregivers[Immediately post intervention after the "B" phase.] Heart rate using a chest strap Polar Heart Rate monitor. ; Heart rate will be recorded every 5 seconds throughout the intervention (S610, Polar, Finland). [Heart rate is a target behaviour during the elliptical training. This will be measured at each session during the intervention over the 8 weeks. The primary end point is the heart rate at post intervention (end of phase B).] Rectus Femoris muscle morphology description: Muscle thickness ; Ultrasonography is a reliable and clinically relevant method of determining and measuring muscle thickness in children with cerebral palsy. It is a safe and non‐invasive technique with no exposure to ionising radiation. Real‐time ultrasound is performed quickly and accurately within the clinic, so there is no need for anesthetics or hospital admissions. ; Real time ultrasound imaging (B Mode Ultrasound) will be used to determine bilateral rectus femoris muscle thickness, muscle length and tendon length. A standardised position will be used with the Hip and knee at 90 degrees of flexion. This position will be supported by foam blocks and by a research assistant, using a goniometer and angle finder to maintain this position. ; The probe will be oriented to this line, running longitudinal to the plane. Images will be taken at this point until there are 5 successive decreases in measurements. This method will be optimised during the pilot testing. ; [This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Rectus Femoris: Muscle length as measured by 2D muscle ultrasound as describe previously[This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.] Sedentary behaviour ; Participants will be asked to wear the watchlike device (Actigraph GTX3) over 7 days and nights. The raw data will then be convertedusing proprietory algorithms on the Actilife software to identify and quantify time spend in sedentary activities (i.e. lying down or sitting). [This is part of the generalisation probe measures which will occur 3 times: (1) in the 7 days leading into Pre baseline, (2)over 7 days Immediately pre‐intervention which is also immediately post baseline and (3) for 7 days immediately post intervention.] Sleep Disturbance Scale ; A screening questionnaire that has been used as a measure of children’s sleep (including domains of sleep onset, respiration, parasomnias such as restlessness and bruxism). It can be used to measure previous 4 weeks of children’s sleep, and has been used before and after sleep related interventions[This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre‐intervention which is also immediately post baseline and (3) immediately post intervention.]