Investigating of Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training On Gait Parameters In Children With Diplegic Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 20
- Primary Endpoint
- Walking energy expenditure measurements were done with breath by breath method.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
intervention group
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.
Intervention: Cycling Functional Electrical Stimulation (Other)
intervention group
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.
Intervention: Physiotherapy (Other)
control group
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: Physiotherapy (Other)
Outcomes
Primary Outcomes
Walking energy expenditure measurements were done with breath by breath method.
Time Frame: 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.
Time Frame: 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 Outcomes
- Gross motor function was measured using GMFM.(change from baseline gross motor funciton at 8 weeks)
- Modified Ashworth (MAS) scale was used to evaluate muscle tone.(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.(change from baseline gross motor funciton at 8 weeks)
- Balance was assessed with pediatric balance scale (PBS).(change from baseline gross motor funciton at 8 weeks)
- Dynamic balance was assessed withTime up & go test (TUG).(change from baseline gross motor funciton at 8 weeks)
- Quality of life was assessed withThe Child Health Questionnaire (CHQ-PF50).(change from baseline gross motor funciton at 8 weeks)
- Daily living activity was assessed with Pediatric Evaluation of Disability Inventory.(change from baseline gross motor funciton at 8 weeks)
Investigators
Duygu Turker
principal investigator
Hacettepe University