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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Diplegic Cerebral Palsy
• Intervention / Treatment: Other: Physiotherapy; Other: Cycling Functional Electrical Stimulation

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Physiotherapy; Other: Cycling Functional Electrical Stimulation
ACTIVE_COMPARATOR: 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.	Other: Physiotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: yavuz yakut, prof.dr, Hacettepe University

Publications and helpful links

General Publications

• Dodd KJ, Taylor NF, Damiano DL. A systematic review of the effectiveness of strength-training programs for people with cerebral palsy. Arch Phys Med Rehabil. 2002 Aug;83(8):1157-64. doi: 10.1053/apmr.2002.34286.
• Kerr C, McDowell B, McDonough S. Electrical stimulation in cerebral palsy: a review of effects on strength and motor function. Dev Med Child Neurol. 2004 Mar;46(3):205-13. doi: 10.1017/s0012162204000349. No abstract available.
• Chiu HC, Ada L. Effect of functional electrical stimulation on activity in children with cerebral palsy: a systematic review. Pediatr Phys Ther. 2014 Fall;26(3):283-8. doi: 10.1097/PEP.0000000000000045.
• Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.
• Fowler EG, Knutson LM, DeMuth SK, Sugi M, Siebert K, Simms V, Azen SP, Winstein CJ. Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS)--a randomized controlled trial protocol for a stationary cycling intervention. BMC Pediatr. 2007 Mar 21;7:14. doi: 10.1186/1471-2431-7-14.
• Williams H, Pountney T. Effects of a static bicycling programme on the functional ability of young people with cerebral palsy who are non-ambulant. Dev Med Child Neurol. 2007 Jul;49(7):522-7. doi: 10.1111/j.1469-8749.2007.00522.x.
• Johnston TE, Wainwright SF. Cycling with functional electrical stimulation in an adult with spastic diplegic cerebral palsy. Phys Ther. 2011 Jun;91(6):970-82. doi: 10.2522/ptj.20100286. Epub 2011 Apr 28.
• Trevisi E, Gualdi S, De Conti C, Salghetti A, Martinuzzi A, Pedrocchi A, Ferrante S. Cycling induced by functional electrical stimulation in children affected by cerebral palsy: case report. Eur J Phys Rehabil Med. 2012 Mar;48(1):135-45. Epub 2011 Apr 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): April 15, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: June 3, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Gait Analysis; Diplegic Cerebral Palsy; Cycling With Functional Electrical Stimulation; Functional Strenght Training; Qxygen Consumption
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: GO 14/119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No