Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training in Cerebral Palsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating of Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training On Gait Parameters In Children With Diplegic Cerebral Palsy

Conditions
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Cerebral Palsy, Diplegic Cerebral Palsy

Intervention / Treatment
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* Other: Cycling Functional Electrical Stimulation
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cerebral palsy classified in levels I - II of the Gross Motor Function Classification System (GMFCS) able to follow and accept verbal instruction Exclusion Criteria: any orthopaedic surgery or botulinum toxin injection in the past 6 months, children whose parents refused to participate

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>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. | Other: Cycling Functional Electrical Stimulation<br> <br> Other: Physiotherapy<br> <br> |
| Active Comparator: control group<br>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. | Other: Physiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait was assessed using a three-dimensional Gait Analysis motion system. | 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. | change from baseline gross motor funciton at 8 weeks | 
| Walking energy expenditure measurements were done with breath by breath method. | Walking energy expenditure measurements were done with breath by breath method using an open-circuit indirect calorimeter (Vmax 29c, Sensormedics, USA). | change from baseline gross motor funciton at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross motor function was measured using GMFM. | 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). | change from baseline gross motor funciton at 8 weeks | 
| Modified Ashworth (MAS) scale was used to evaluate muscle tone. | 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. | change from baseline gross motor funciton at 8 weeks | 
| The 30s Repetition Maximum test was used to assess functional muscle strength of the lower extremities. | The three closed kinetic chain exercises of lateral step-up test, sit to stand, and attain stand through half knee were used. | change from baseline gross motor funciton at 8 weeks | 
| Balance was assessed with pediatric balance scale (PBS). | 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. | change from baseline gross motor funciton at 8 weeks | 
| Dynamic balance was assessed withTime up & go test (TUG). | 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. | change from baseline gross motor funciton at 8 weeks | 
| Daily living activity was assessed with Pediatric Evaluation of Disability Inventory. | 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. | change from baseline gross motor funciton at 8 weeks | 
| Quality of life was assessed withThe Child Health Questionnaire (CHQ-PF50). | 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. | change from baseline gross motor funciton at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Strenght Training, Quality of Life, Qxygen Consumption, Diplegic Cerebral Palsy, Cycling With Functional Electrical Stimulation, Gait Analysis