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Effects of Functional Electrical Stimulation on Gait in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Congenital, Muscle Spasticity

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
WalkAide
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Congenital focused on measuring Cerebral Palsy, Muscle Spasticity, Orthoses, Functional Electrical Stimulation, Prospective

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Children above age of 6 years, with hemiplegic and asymmetric diplegic CP GMFCS I/II, with drop foot and dynamic contracture of the ankle on examination, who are being treated at the CP clinic at Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Exclusion Criteria:

  • Children with fixed contracture of ankle joint (passive range of motion< 0 degree); children who had orthopedic surgery to the leg or had botulinum toxin injection to the plantar or dorsiflexor muscles within the 6 months prior to the study; children who cannot tolerate the electrical stimulation delivered by the device.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    WalkAide

    Arm Description

    Outcomes

    Primary Outcome Measures

    "Six min walk test"
    This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (Maher C et al ,2008)
    "Gross motor function measure" (GMFM) section E
    The Gross Motor Function Measure (GMFM) is a clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. Section E evaluate walking, running and jumping skills (Rosenbaum PL et al, 2008)
    "Timed up and down stairs test"
    This test measures time going up and down 14-step flight of stairs (Zaino CA et al 2004)
    Ankle angle at initial contact
    measured by "Gait analysis laboratory"
    Peak dorsiflexion angle in swing phase
    measured by "Gait analysis laboratory"

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2015
    Last Updated
    May 31, 2015
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02462018
    Brief Title
    Effects of Functional Electrical Stimulation on Gait in Children With Cerebral Palsy
    Official Title
    Effects of Functional Electrical Stimulation on Gait in Children With Hemiplegic and Diplegic Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture. Muscle weakness and spasticity associated with CP limit the joint range of motion and negatively impact ambulatory ability. Most ambulatory children with CP are prescribed with ankle-foot orthoses (AFOs) to improve ankle position and stability and to maintain muscle range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle weakness and atrophy. During the last years a novel method is being used for treating upper motor neuron drop foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES). These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating the tibialis anterior muscle. Most of the studies of FES devices were conducted on adult population. These studies showed improvement in laboratory and functional gait parameters. There are relatively few studies on children with hemiplegic or diplegic CP with favorable results. There is no solid evidence whether the improvements seen in laboratory setting of children with CP, are reflected on functional ambulation in daily life. In addition, there are no defined parameters which could predict the response to FES among those children. The aim of this study is to determine whether using FES device (WalkAide; Innovative Neurotronics, Austin, TX, USA) improves daily motor function and gait parameters in children with spastic hemiplegic or diplegic CP. additionally, we aim to define clinical and biomechanical parameters that can predict a favorable response to using the FES device.
    Detailed Description
    Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture. Individuals with CP exhibit a wide range of motor disabilities; however, approximately 70% of them achieve the ability to ambulate during childhood, albeit with difficulty. Muscle weakness and spasticity associated with CP limit the joint range of motion and negatively impact ambulatory ability. The ankle joint is affected in virtually all patients. Insufficient ankle dorsiflexion during swing, foot drop and excessive plantar flexion during early to mid-stance may cause standing and walking instability with greater risk for falling. Most ambulatory children with CP are prescribed with ankle-foot orthoses (AFOs) to improve ankle position and stability for standing and walking and to maintain muscle range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle weakness and atrophy, leading to further loss of function over time. In addition many children, especially adolescents, avoid using AFOs because of discomfort and concerns regarding negative effects on body image. During the last years a novel method is being used for treating upper motor neuron drop foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES). These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating the tibialis anterior muscle. FES devices, by actively stimulating the muscle have theoretical advantages over static AFOs. In addition the stimulator can be cosmetically better accepted. Most of the studies of FES devices were conducted on adult population with upper motor neuron defect. These studies showed improvement in laboratory and functional gait parameters.In addition to the direct orthotic effect of the device during utilization, some studies also indicated a therapeutic effect ("carry over effect"), which was postulated to arise through the neural plasticity facilitation by increasing the strength of afferent feedback inputs to CNS. Whether this therapeutic effect actually exists and for how long is still unclear. A variety of Functional Electrical Stimulation (FES) devices are being increasingly prescribed as a treatment option in CP children. There are relatively few studies on children with hemiplegic or diplegic CP. Prosser et al(Prosser et al 2013), reported good acceptability of FES device in CP population. Other studies have showed as well favorable results, with improvement of ankle kinematics parameters, such as dorsiflexion angle at swing phase and initial contact. Damiano et al (Damiano et al 2012) showed evidence of use-dependent muscle plasticity with increased tibialis anterior muscle thickness while using FES devices in CP patients. There is still no solid evidence whether the improvements seen in laboratory setting are reflected on functional ambulation in daily life. Some studies showed improvement in walking speed while others did not. Moreover, some studies also indicated an effect variability among subjects, which could be partially explained by the heterogeneity of CP population. There are no defined parameters which could predict the response to FES among those children. The WalkAide(WalkAide; Innovative Neurotronics, Austin, TX, USA) is a battery-operated, small medical electrical stimulator device, which attaches to a molded cuff located just below the knee and produces controlled dorsiflexion of the foot during walk.It utilizes a tilt sensor and accelerometer to control the timing and duration of the stimulation during walking.Use of the Tilt Sensor to trigger stimulation eliminates the need for additional components or external wires. The aim of this study is to determine whether using WalkAide device, improves daily motor function and gait parameters in children with spastic hemiplegic or diplegic CP. In addition, we aim to define clinical and biomechanical parameters that can predict a favorable response to using the FES device.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Congenital, Muscle Spasticity
    Keywords
    Cerebral Palsy, Muscle Spasticity, Orthoses, Functional Electrical Stimulation, Prospective

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    WalkAide
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    WalkAide
    Intervention Description
    Patiants with hemiplegic or asymmetric diplegic CP will use WalkAide device for 4 months .First month for adjustment and three months of daily using of the device. For each patient two assessments will be conducted: at baseline and at post-intervention follow-up. During the assessments each child will go through: A. Medical interview and neurological and physical therapist examination. B. Motor function tests: "6 min walk test", Gross motor function measure (GMFM) ,"Timed up and down stairs test" (TUDS), walking on a ramp ,with and without the FES device. C. Gait analysis test with and without FES device. D. Parents will be requested to complete questionnaires on the frequency of falling. E. On the second assessment parents wiil be requested to complete a questionnaire about the compliance to the FES.
    Primary Outcome Measure Information:
    Title
    "Six min walk test"
    Description
    This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (Maher C et al ,2008)
    Time Frame
    4 months
    Title
    "Gross motor function measure" (GMFM) section E
    Description
    The Gross Motor Function Measure (GMFM) is a clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. Section E evaluate walking, running and jumping skills (Rosenbaum PL et al, 2008)
    Time Frame
    4 months
    Title
    "Timed up and down stairs test"
    Description
    This test measures time going up and down 14-step flight of stairs (Zaino CA et al 2004)
    Time Frame
    4 months
    Title
    Ankle angle at initial contact
    Description
    measured by "Gait analysis laboratory"
    Time Frame
    4 months
    Title
    Peak dorsiflexion angle in swing phase
    Description
    measured by "Gait analysis laboratory"
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Children above age of 6 years, with hemiplegic and asymmetric diplegic CP GMFCS I/II, with drop foot and dynamic contracture of the ankle on examination, who are being treated at the CP clinic at Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. Exclusion Criteria: Children with fixed contracture of ankle joint (passive range of motion< 0 degree); children who had orthopedic surgery to the leg or had botulinum toxin injection to the plantar or dorsiflexor muscles within the 6 months prior to the study; children who cannot tolerate the electrical stimulation delivered by the device.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aviva Fatal-Valvski, MD
    Phone
    972-36974517
    Email
    afatal@post.tau.ac.il

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22924431
    Citation
    Prosser LA, Curatalo LA, Alter KE, Damiano DL. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2012 Nov;54(11):1044-9. doi: 10.1111/j.1469-8749.2012.04401.x. Epub 2012 Aug 27.
    Results Reference
    background
    PubMed Identifier
    13761879
    Citation
    LIBERSON WT, HOLMQUEST HJ, SCOT D, DOW M. Functional electrotherapy: stimulation of the peroneal nerve synchronized with the swing phase of the gait of hemiplegic patients. Arch Phys Med Rehabil. 1961 Feb;42:101-5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    18467936
    Citation
    Maher CA, Williams MT, Olds TS. The six-minute walk test for children with cerebral palsy. Int J Rehabil Res. 2008 Jun;31(2):185-8. doi: 10.1097/MRR.0b013e32830150f9.
    Results Reference
    background
    PubMed Identifier
    18318732
    Citation
    Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1.
    Results Reference
    background
    PubMed Identifier
    17057533
    Citation
    Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A.
    Results Reference
    background

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    Effects of Functional Electrical Stimulation on Gait in Children With Cerebral Palsy

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