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

Primary Purpose

Cerebral Palsy, Diplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cycling Functional Electrical Stimulation
Physiotherapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Diplegic Cerebral Palsy, Cycling With Functional Electrical Stimulation, Gait Analysis, Functional Strenght Training, Quality of Life, Qxygen Consumption

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    intervention group

    control group

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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.
    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).

    Secondary Outcome Measures

    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).
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    June 3, 2018
    Last Updated
    July 24, 2018
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03600012
    Brief Title
    Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training in Cerebral Palsy
    Official Title
    Investigating of Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training On Gait Parameters In Children With Diplegic Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    April 15, 2015 (Actual)
    Study Completion Date
    December 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Diplegic Cerebral Palsy
    Keywords
    Diplegic Cerebral Palsy, Cycling With Functional Electrical Stimulation, Gait Analysis, Functional Strenght Training, Quality of Life, Qxygen Consumption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Single (Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Cycling Functional Electrical Stimulation
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy
    Primary Outcome Measure Information:
    Title
    Gait was assessed using a three-dimensional Gait Analysis motion system.
    Description
    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.
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Title
    Walking energy expenditure measurements were done with breath by breath method.
    Description
    Walking energy expenditure measurements were done with breath by breath method using an open-circuit indirect calorimeter (Vmax 29c, Sensormedics, USA).
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Secondary Outcome Measure Information:
    Title
    Gross motor function was measured using GMFM.
    Description
    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).
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Title
    Modified Ashworth (MAS) scale was used to evaluate muscle tone.
    Description
    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.
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Title
    The 30s Repetition Maximum test was used to assess functional muscle strength of the lower extremities.
    Description
    The three closed kinetic chain exercises of lateral step-up test, sit to stand, and attain stand through half knee were used.
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Title
    Balance was assessed with pediatric balance scale (PBS).
    Description
    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.
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Title
    Dynamic balance was assessed withTime up & go test (TUG).
    Description
    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.
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Title
    Daily living activity was assessed with Pediatric Evaluation of Disability Inventory.
    Description
    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.
    Time Frame
    change from baseline gross motor funciton at 8 weeks
    Title
    Quality of life was assessed withThe Child Health Questionnaire (CHQ-PF50).
    Description
    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.
    Time Frame
    change from baseline gross motor funciton at 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    yavuz yakut, prof.dr
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    14995090
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24819681
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12161840
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20093327
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17374171
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17593125
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21527385
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21508913
    Citation
    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.
    Results Reference
    background

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

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