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

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ClinicalTrials.gov Identifier: NCT02462018
Recruitment Status : Unknown
Verified April 2015 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy, Congenital Muscle Spasticity Device: WalkAide Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Functional Electrical Stimulation on Gait in Children With Hemiplegic and Diplegic Cerebral Palsy
Study Start Date : May 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: WalkAide Device: WalkAide

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 Measures :
  1. "Six min walk test" [ Time Frame: 4 months ]
    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)

  2. "Gross motor function measure" (GMFM) section E [ Time Frame: 4 months ]
    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)

  3. "Timed up and down stairs test" [ Time Frame: 4 months ]
    This test measures time going up and down 14-step flight of stairs (Zaino CA et al 2004)

  4. Ankle angle at initial contact [ Time Frame: 4 months ]
    measured by "Gait analysis laboratory"

  5. Peak dorsiflexion angle in swing phase [ Time Frame: 4 months ]
    measured by "Gait analysis laboratory"



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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462018


Contacts
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Contact: Aviva Fatal-Valvski, MD 972-36974517 afatal@post.tau.ac.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Publications:
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02462018     History of Changes
Other Study ID Numbers: TLV-0192-15
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: April 2015

Keywords provided by Tel-Aviv Sourasky Medical Center:
Cerebral Palsy
Muscle Spasticity
Orthoses
Functional Electrical Stimulation
Prospective

Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Muscle Spasticity
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations