None listed
Conditions
Brief summary
Aim: The primary aim of this project is to evaluate the feasibility of functional electrical stimulation cycling exercise for persons moderately affected cerebral palsy. Electrical stimulation uses brief electrical pulses applied via gel-electrodes to the muscles to produce muscle contractions in weak or paralyzed muscles. Functional Electrical Stimulation cycling devices rhythmically apply electrical stimulation to the leg muscles to induce muscle contractions that can cause paralyzed legs to pedal a stationary exercycle and exercise the legs. Electrical stimulation exercises has many disadvantages, including the cost of equipment, the time invested in setting up the equipment each session and the low intensity of exercise it provides. However, persons with CP who have more severe mobility limitations often have less options for exercise, and even though it has many drawbacks electrical stimulation may be a good exercise mode for this population. Intervention: In this project twelve adolescents with moderate CP (i.e. gross motor function classification scale III) will perform 8 weeks of functional electrical cycling training at the Faculty of Health Sciences, University of Sydney. The method of functional electrical stimulation cycling which will be employed is one which we have shown to produce better enhancements in muscle mass than prior methods of electrical stimulation cycling. Participants will perform cycling two times per week and each session will involve 45min of exercise. Eight muscle groups will be electrically stimulated via self-adhesive gel electrodes. The quadriceps, gluteal muscles, hamstrings, and calf muscles of each leg will be electrically stimulated. We will measure the outcome variables before and after the 8 week intervention. Hypothesis: The primary hypothesis tested is that our method of electrical stimulation cycling is a feasible form of exercise for persons with moderate CP. We believe that appropriately designed ES-cycling exercise can enhance the exercise options that persons with moderate cerebral palsy can currently perform. We will measure feasibility through adherence to the program and test outcome measures related to health and function. Secondary hypotheses include that regular exercise with an appropriate ES cycling system results in leg muscle hypertrophy (assessed via ultrasound and leg circumference measures) in people with moderate CP and consequently produces improvements in lower limb function, and quality of life. Evaluation of our secondary hypotheses also include measures of perceived quality of life, cycling ability, leg extension strength, leg flexion strength, gait and leg function, and spasticity/tonus.
Interventions
Pilot Study of Functional Electrical Stimulation (FES) Cycling Exercise in Cerebral Palsy
It is necessary for persons with cerebral palsy (CP) to exercise in order to prevent secondary comorbidities later in life such as declining physical performance, health and premature sarcopenia. However, persons with CP with more severe mobility limitation often have reduced options for exercise and often the exercise intensity that can be achieved is low. Functional electrical stimulation (FES) leg cycl
Pilot Study of Functional Electrical Stimulation (FES) Cycling Exercise in Cerebral Palsy It is necessary for persons with cerebral palsy (CP) to exercise in order to prevent secondary comorbidities later in life such as declining physical performance, health and premature sarcopenia. However, persons with CP with more severe mobility limitation often have reduced options for exercise and often the exercise intensity that can be achieved is low. Functional electrical stimulation (FES) leg cycling may be useful to enhance exercise options and bestow benefit in persons with CP. FES may be able to assist voluntary contractions and achieve a training effect on lower limb muscle mass leading to changes in function and quality of life. However, FES cycling has many disadvantages, including the cost of equipment, the time invested in setting up the equipment each session, and that the stimulation sensation is unpleasant. Prior to this application, we have demonstrated the feasibility of our method of FES cycling for persons with advanced multiple sclerosis (MS) (Fornusek 2014). Clinical findings in CP can be similar to advanced MS with paresis, hypertonia and variable but often preserved sensation. This study examines the feasibility of FES cycling in persons with moderate CP (GMFCS-III). Participants will perform FES cycling training (2 x per week for 45min per session) for 8 weeks at 10 RPM on a custom isokinetic functional electrical stimulation cycle ergometer (University of Sydney). The sessions will be administered one-on-one by physiotherapy and exercise science students from the University of Sydney with overseeing supervision from a rehabilitation engineer with 20 years experience in FES cycle design and training experience. The FES cycling training program has been adapted to suit persons with CP and enhance muscle hypertrophy. The duration and intensity of each exercise session will be tailored to the initial strength and fitness levels of each individual and exercise duration will be increased gradually over the first 3 weeks up to 45 min. The quadriceps, gluteal muscles, hamstrings, and tibialis anterior muscles of each leg will be stimulated via self-adhesive gel electrodes. The stimulation parameters will be 300 microsecond pulse width and 35 Hz pulse frequency. The pulse amplitude (mA) will be personalized to the individual tolerance of each individual and slowly increased from the beginning of each session as the participant becomes accustomed to the uncomfortable sensation. Exercise intensity will be enhanced by the participant contributing voluntary contractions to the cycling action where possible. A computer display will provide participants with visual feedback of their cycling performance. The FES cycling intervention will be performed at the FitAbility Clinic (C Block) at the School of Exercise & Sports Science (Faculty of Health Sciences, The University of Sydney). This pilot study is to test the feasibility of using FES cycling in adolescents with cerebral palsy and collect data for a larger future study. Feasibility will assessed from the appropriateness, acceptability, number of adverse events, and adherence rate of the intervention. Adherence will be evaluated by average percentage of sessions and amount of training time completed in the 8 week training. Reasons for absences from training will be recorded. Appropriateness and acceptability will be assessed by a custom survey. Effectiveness will be assessed via secondary health and functional measures that might be enhanced due to the exercise intervention.
Sponsors
Dr Che Fornusek
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for participants are: 1) 13-18 years old 2) The diagnosis of Cerebral Palsy 3) GMFCS Level III (uses an assistive mobility device or a wheelchair for long distances) 4) Sufficient covering of the femoral head in the acetabulum (MIGR% < 40%) and no significant scoliosis (primary curve >40 degrees). 5) Absence of severe tactile hypersensitivity in the lower extremities 6) Visuoperceptual skills sufficient to follow multiple step commands and to attend to tasks associated with data collection 7) The ability to maintain an upright position with minimal support and to sit in a wheelchair for approximately one hour. 8) Have adequate passive range of motion of the hips, knees and ankle to complete a full revolution of the cycle ergometer. 9) Ability to communicate pain or discomfort directly with the researcher or indirectly via a carer to participate in cycling trials (Communication Function Classification System less than or equal to 3) 10) The willingness to participate in two training sessions per week for 8 weeks lasting approximately 1 hour each session (approximately 15 min of set up and up to 45 minutes of training) and to complete 2-3 days of testing during each assessment period (baseline, post testing). 11) The ability to gain consent from participant and parent/guardian
Exclusion criteria
Exclusion criteria are: 1) Lower extremity joint pain during cycling 2) Spinal fusion that extends to the pelvis 3) Hip, knee, or ankle joint instability or dislocation 4) History of lower limb stress fractures in the past year 5) Pulmonary disease limiting exercise tolerance 6) Symptomatic or known cardiac disease 7) Unhealed wounds or pressure sores 8) Muscles that are non-responsive to electrical stimulation 9) History of surgery or traumatic fracture to the lower extremities within the past year 10) Botox injections to the lower extremity muscles within the past 6 months. 11) Severe spasticity in legs (score of 4 on the Modified Ashworth scale) 12) Severely limited range of joint motion/irreversible muscle contractures that prevent the subject from being able to be safely positioned on the cycle. 13) Presence of an uncontrolled seizure disorder 14) Pregnancy
Outcome results
None listed