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

NCT02462018 | Unknown Phase 4

• 1 other identifier: TLV-0192-15
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy, Congenital; Muscle Spasticity

Keywords

Cerebral Palsy; Muscle Spasticity; Orthoses; Functional Electrical Stimulation; Prospective

Outcome Measures

Primary Outcomes (5)

• "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)

  4 months

• "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)

  4 months

• "Timed up and down stairs test"

  This test measures time going up and down 14-step flight of stairs (Zaino CA et al 2004)

  4 months

• Ankle angle at initial contact

  measured by "Gait analysis laboratory"

  4 months

• Peak dorsiflexion angle in swing phase

  measured by "Gait analysis laboratory"

  4 months

Study Arms (1)

WalkAide

EXPERIMENTAL

Device: WalkAide

Interventions

WalkAide DEVICE

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.

WalkAide

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (5)

• 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.

  PMID: 22924431 BACKGROUND

• 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.

  PMID: 13761879 BACKGROUND

• 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.

  PMID: 18467936 BACKGROUND

• 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.

  PMID: 18318732 BACKGROUND

• 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.

  PMID: 17057533 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aviva Fatal-Valvski, MD

CONTACT

972-36974517; afatal@post.tau.ac.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 3, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: June 3, 2015

Record last verified: 2015-04