Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training in Cerebral Palsy
- Conditions
- Diplegic Cerebral PalsyCerebral Palsy
- Interventions
- Other: Cycling Functional Electrical StimulationOther: Physiotherapy
- Registration Number
- NCT03600012
- Lead Sponsor
- Hacettepe University
- Brief Summary
The aim of this study was to investigate the effects of cycling functional electrical stimulation applied to the lower extremities of children with spastic diplegic cerebral palsy (CP) on the gait parameters and daily living activities.
- Detailed Description
Cerebral palsy (CP) is a broadly-defined neurological disorder that encompasses brain injury or malformation in a child's brain that occurs before, during, or immediately after birth and results in impaired motor control. Because of the broad definition of CP, people with CP can exhibit a very wide range of symptoms, and no two people with CP will exhibit the same symptoms. However, people with CP generally have difficulty moving parts of their bodies normally because of muscle weakness or paralysis, impaired muscle coordination, and/or spasticity. Impaired motor control can also be accompanied by intellectual impairment, seizures, or sensory impairment.
Physical impairment can severely limit participation in physical activity by people with CP, as is true for anyone with physical impairments. Lack of physical activity can lead to the development of any number of chronic diseases, especially in children with disabilities like CP. Exercise is an effective method for mitigating the negative secondary health effects of neuromuscular diseases like CP, but how can someone with CP exercise despite their impaired motor control, especially when 31% of children with CP have limited walking ability.
Cycling is an exercise that challenges the muscular and cardiovascular systems, potentially leading to improved health, fitness, and well-being. Cycling with functional electrical stimulation (FES) has been primarily used by people with spinal cord injury; improvements have been seen in bone mineral density, muscle strength (force-generating capacity), and cardiorespiratory measures. Recent reports indicated benefits for people after stroke; improvements in strength and motor control were seen when an FES cycling program was added to traditional rehabilitation. However, there have been no reports of FES cycling for children with CP.
Cycling with FES may be a suitable intervention for with CP because the seated position decreases balance demands, and FES can create or augment pedaling forces. Many people with CP may be incapable of generating sufficient forces during cycling to reach the exercise intensity needed for optimal fitness-related outcomes and musculoskeletal benefits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- cerebral palsy
- classified in levels I - II of the Gross Motor Function Classification System (GMFCS)
- able to follow and accept verbal instruction
- any orthopaedic surgery or botulinum toxin injection in the past 6 months,
- children whose parents refused to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group Physiotherapy intervention group: Cycling Functional Electrical Stimulation \& Physiotherapy Children in intervention group were taken in a therapy program withRT 300 SLSA FES system for cycling functional electrical stimulation training additionly to physiotherapy program including weight shifting, knee and hip strenging and gait training for 8 weeks, 3 sessions in a week and 45 min per session. control group Physiotherapy control group: Physiotherapy Children with cp in control group were taken physiotherapy program including weight shifting, knee and hip strenging and gait training for 8 weeks, 3 times in a week, 45 min per session. intervention group Cycling Functional Electrical Stimulation intervention group: Cycling Functional Electrical Stimulation \& Physiotherapy Children in intervention group were taken in a therapy program withRT 300 SLSA FES system for cycling functional electrical stimulation training additionly to physiotherapy program including weight shifting, knee and hip strenging and gait training for 8 weeks, 3 sessions in a week and 45 min per session.
- Primary Outcome Measures
Name Time Method Walking energy expenditure measurements were done with breath by breath method. change from baseline gross motor funciton at 8 weeks Walking energy expenditure measurements were done with breath by breath method using an open-circuit indirect calorimeter (Vmax 29c, Sensormedics, USA).
Gait was assessed using a three-dimensional Gait Analysis motion system. change from baseline gross motor funciton at 8 weeks Gait was assessed using a three-dimensional, seven-camera, VICON 512 motion measurement system (Oxford Metrics Ltd., Oxford, UK). The VICON Clinical Manager software was used for calculating and plotting temperospatial parameters, sagittal plane joint motion data, and kinematic data. Fifteen reflective markers were placed on specific anatomic landmarks bilaterally of the subject's pelvis, thighs, shanks and feet according to the marker protocol of Davis et al.
- Secondary Outcome Measures
Name Time Method Gross motor function was measured using GMFM. change from baseline gross motor funciton at 8 weeks The GMFM measures capability, or what a child 'can do' in a standardized environment. Items include tasks related to lying and rolling, sitting, crawling and kneeling, standing, walking, running and jumping, with the most difficult items on the scale representing abilities obtained by children developing typically by 5 years of age. Each item is scored by observation on a four-point ordinal scale (0-3).
Modified Ashworth (MAS) scale was used to evaluate muscle tone. change from baseline gross motor funciton at 8 weeks The MAS is a 6-point rating scale which assesses muscle tone by manually manipulating the joint through its available range of motion and clinically recording the resistance to passive movements.
The 30s Repetition Maximum test was used to assess functional muscle strength of the lower extremities. change from baseline gross motor funciton at 8 weeks The three closed kinetic chain exercises of lateral step-up test, sit to stand, and attain stand through half knee were used.
Balance was assessed with pediatric balance scale (PBS). change from baseline gross motor funciton at 8 weeks Functional balance was assessed using the PBS, which consists of 14 tasks similar to activities of daily living. The items are scored on a five-point scale (0, 1, 2, 3 or 4), with zero denoting an inability to perform the activity without assistance and four denoting the ability to perform the task with complete independence. The score is based on the time for which a position can be maintained, the distance to which the upper limb is capable of reaching in front of the body, and the time needed to complete the task. The maximum score is 56 points.
Dynamic balance was assessed withTime up & go test (TUG). change from baseline gross motor funciton at 8 weeks TUG test a performance measure of speed to complete a sequenced functional mobility task. The TUG test measures, the time required for an individual to stand up from a standard chair with armrest, walk 3m, turn around, walk back to the chair, and sit down again. The test has been widely used in clinical practice as an outcome measure to evaluate functional mobility.
Quality of life was assessed withThe Child Health Questionnaire (CHQ-PF50). change from baseline gross motor funciton at 8 weeks CHQ is a multidimensional generic health status questionnaire developed for clinicians and researchers interested in measuring children's functional health and well-being. It is available as a parent/proxy report for children aged 5-18 years and as a corresponding self-report for adolescents. The CHQ PF50 includes 13 single and multi-item scales that tap concepts contributing to overall functioning and well-being for children in the context of their family and social environments. One of the purported advantages of the CHQ PF50 is the availability of two summary scores (psychosocial and physical), which may be used in the evaluation of outcomes when information at the scale level is not practical.
Daily living activity was assessed with Pediatric Evaluation of Disability Inventory. change from baseline gross motor funciton at 8 weeks Pediatric Evaluation of Disability Inventory quantitatively measures functional performance. This questionnaire was administered in interview form to one of the child's caregivers who was knowledgeable about the performance of the child in typical activities and tasks of daily routine. The first part of the questionnaire was used. This assesses skills in the child's repertoire grouped into three functional categories: self-care (73 items), mobility (59 items) and social function (65 items). An item is scored 0 (zero) when the child is unable to perform the activity or 1 (one) when the activity is part of the child's repertoire of skills. The scores are totaled per category.