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Functional Electrical Stimulation During Walking in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03440632
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

Children with spastic cerebral palsy (CP) often walk with insufficient ankle dorsiflexion in the swing phase. A pathological gait, known as drop-foot gait, can be the result and this has 2 major complications: foot-slap during loading response and toe-drag during swing. This is partly caused by weakness of the anterior tibial muscle and partly due to co-contraction of both the fibular- and anterior tibial muscle. For classification of gait, the Winters scale can be used, where unilateral CP with dropfoot is classified as type I.

In daily life these problems cause limited walking distance and frequent falls, leading to restrictions in participating in daily life. The current guideline for spastic cerebral palsy describes the following therapies: 1) conservative therapy (physiotherapy, orthopaedic shoes and orthoses) 2) drugs suppressing spasticity 3) surgical interventions.

Functional electrical stimulation (FES) may be an effective alternative treatment for children with spastic CP and a drop foot. By stimulating the fibular nerve or the anterior tibial muscle directly during the swing phase, dorsiflexion of the foot is stimulated. In contrast to bracing, FES does not restrict motion, but does produce muscle contraction, and thus has the potential to increase strength and motor control through repetitive neural stimulation over time.

In a systematic review the investigators found that FES immediately improves ankle dorsal flexion and reduces falls and these effects also sustain. However, it should be noted that the level of evidence is limited. Until now, the use of FES in CP is limited and no data exist about the effects on walking distance (activity level) and participation level.

The overall objective of this study is to conduct a randomised cross-over intervention trial in children with unilateral spastic CP with 12 weeks of FES (for every participant) and 18 weeks of conventional therapy. The effectiveness of FES will be examined at participation leven, using individual goal attainment. Next to that the effect at gait will be measured. An additional goal is to investigate the cost effectiveness of FES, which, in case of a positive effect, may support allowance by insurance companies.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Spastic Foot Drop Device: FES Not Applicable

Detailed Description:

Children with spastic cerebral palsy often walk with insufficient ankle dorsiflexion in the swing phase or with eversion of the foot. A pathological gait, known as drop-foot gait, can be the result and this has 2 major complications: foot-slap during loading response and toe-drag during swing. This is partly caused by weakness of the anterior tibial muscle and partly due to co-contraction of both the fibular- and anterior tibial muscle. In time, the disorder appears to be progressive due to atrophy and contractures of the muscle and increasing bodyweight. For classification of gait, the Winters scale can be used, where unilateral CP with dropfoot is classified as type I.

In daily life these problems cause limited walking distance and frequent falls. This can lead to restrictions in participating in daily activities at school and in leisure. The current guideline for spastic cerebral palsy describes the following therapies: 1) conservative therapy, which includes physiotherapy, orthopaedic shoes and orthoses. 2) systemically and locally applied drugs suppressing spasticity. 3) surgical interventions, e.g. tenotomy, transposition and osteotomy. In each intervention, there is the risk of side effects, such as sedation with oral medications, pressure sores and atrophy in a static orthosis, temporary effect in a Botulinum toxin A treatment and surgical complications due to a result of the surgery, and on the other hand as a result of the execution.

Functional electrical stimulation (FES) may be an effective alternative treatment for children with spastic CP and a drop foot. By stimulating the fibular nerve or the anterior tibial muscle directly during the swing phase, dorsiflexion of the foot is stimulated. In contrast to bracing, FES does not restrict motion, but does produce muscle contraction, and thus has the potential to increase strength and motor control through repetitive neural stimulation over time.

In a systematic review the investigators found that FES immediately improves ankle dorsal flexion and falls. In addition, longer sustained effects of FES on ankle dorsal flexion and falls are found. However, it should be noted only two study studies (4 articles) were of level II class evidence (small RCT) and all other studies used a single subject design. Until now, the use of FES in CP is limited and no data exist about the effects on walking distance (activity level) and participation level.

The overall objective of this study is to conduct a randomised cross-over intervention trial in children with unilateral spastic CP with 12 weeks of FES for every participant and 18 weeks of conventional therapy. The effectiveness of FES will be examined at participation leven, using individual goal attainment. With every individual a goal at walking distance will be set, next to possible other goals. Next to that, results will be measured at the activity and functional level: the effect at gait kinematics (such as ankle dorsiflexion and balance), walking distance, falls, spasticity and muscle force. The type of brain damage of the patients is also taken in to account. An addition al goal is to investigate the cost effectiveness of FES, which, in case of a positive effect, may support allowance by insurance companies.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomisation for the order of treatments and thereby for the total length of the 'conventional therapy phase'.
Masking: Single (Outcomes Assessor)
Masking Description: The physical examination and the advanced analysis of the 3D gait analysis will be done be a blinded examiner.
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation of the Ankle Dorsiflexors During Walking in Children With Unilateral Spastic Cerebral Palsy: a Randomized Crossover Intervention Study
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
FES start

Start: 4 weeks 'adaptation phase' and 8 weeks 'FES phase'. Adaption phase: the stimulus (in Volt) will gradually be increased up to an effective level and the wear time has to be increased from 30 minutes to 6 hours a day. FES phase: the participants have to wear the FES device for minimal 6 hours a day during walking. Usual physiotherapy can be continued during the FES phase.

Second: after the FES phase, this group will enter the 'wash-out' period of 6 weeks for fading of the therapeutic effects, in which they return to their conventional therapy. Afterwards, 12 weeks of conventional therapy (orthoses/shoes and usual physiotherapy) with measurements at start and end will follow.

Device: FES
Functional electrical stimulation of the ankle dorsiflexors during walking, using a (superficial) neurostimulator with tilt sensor.

Conventional start

Start: wearing usual orthoses/shoes on a daily basis for the first 12 weeks of the study. Usual physiotherapy can be continued.

Second: after 12 weeks this group will enter a 6 week watch out phase, and next be switched to FES treatment for 12 weeks, consisting of: 4 weeks 'adaptation phase' with gradual increase of the treatment and 8 weeks 'FES phase'.

Device: FES
Functional electrical stimulation of the ankle dorsiflexors during walking, using a (superficial) neurostimulator with tilt sensor.




Primary Outcome Measures :
  1. Change in goal attainment scale (GAS) [ Time Frame: Setting of goal(s) at start, assessment at every end of a phase: week 12, 18 and 30. ]
    Goal attainment scale: definition of an individual goal at start, followed by a 6- point numeric scale indicating to what extent the goal is (score 0 till +2) or is not (-3 indicating detoriation till -1) reached.


Secondary Outcome Measures :
  1. Change in participation [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    as measured in the Cerebral Palsy Quality of Life Questionnaire (see reference).

  2. Change in walking distance [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    Measured by the 6 minute walking test and the functional mobility scale (3 items, 6-point rating scale).

  3. Change in physical activity [ Time Frame: assessment at start and end of a phase (except for the wash-out phase): week 12 and 30. ]
    measured by activity monitor

  4. Change in frequency of falling [ Time Frame: assessment at every end of a phase: week 12, 18 and 30. ]
    measured by a questionnaire

  5. Change in stability during walking [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    measured by variation of center of mass and margins of stability assessed during 3D gait analysis

  6. Change in ankle dorsiflexion angle [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    measured in degrees during gait analysis during 3D gait analysis

  7. Change in calf muscle activation [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    Assessed by spasticity measurement and electromyography (EMG) during 3D gait analysis

  8. Change in ankle plantarflexion strength during walking [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    Calculated by net push off moments during 3D gait analysis

  9. Change in ankle dorsiflexion and plantarflexion strength [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    measured in Newton by handheld dynamometer

  10. Change in feelings about donning and doffing [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    measured by a questionnaire

  11. Change in patient satisfaction [ Time Frame: assessment at start and every end of a phase: week 12, 18 and 30. ]
    measured by a visual analogue scale with smileys (0 = unsatisfied, 6 = perfectly satisfied).

  12. The compliance and acceptability of FES [ Time Frame: the FES devices measures this automatically during wearing; so this will happen during the 12 weeks of FES therapy ]
    derived from delivered stimulations and hours of wear time in the log file

  13. Type of brain lesion in relation to FES success [ Time Frame: Assessment and analysis of available imaging will be done after completion of the study by the patient, so after week 30, up to week 50 to collect a batch of finished patients. No imaging will be performed because of the study. ]
    Derived from available brain imaging

  14. Cost-effectiveness of FES [ Time Frame: analysis after study completion, week 30, using the EQ-5D-Y results. ]
    compared to conventional therapy

  15. Change in health [ Time Frame: assessment at every end of a phase: week 12, 18 and 30. ]
    EQ-5D-Y Questionnaire, youth version



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral foot drop of central origin, particularly the absence of initial heel contact
  • Participants are currently treated with ankle-foot orthoses or (adapted) shoes to wear on a daily basis
  • Participants ambulate independently, and thus classified as Gross Motor Function Classification System (GMFCS) levels I or II and have a gait type 1 according to Winters et al (4).
  • Participants are able to walk for at least 15 minutes
  • Confirmed cerebral abnormality with MRI (showing medial infarction, maldevelopment of the brain, or porencephaly).
  • Participants are aged 4-18 years at time of inclusion

Exclusion Criteria:

  • Plantarflexion ankle contracture of more than 5 degrees plantarflexion with the knee extended
  • Botulinum toxin A injection to the plantar or dorsiflexor muscle groups within the 6 months before the study
  • Orthopaedic surgery to the legs in the previous year
  • Uncontrolled epilepsy with daily seizures

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): NCT03440632


Contacts
Contact: R.J. Vermeulen, M.D., PhD +31(0)387 7054 jeroen.vermeulen@mumc.nl
Contact: I. Moll, M.D. +31611922127 irene.moll@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: I. Moll, M.D.    +31611922127 ext +31611922127    irene.moll@maastrichtuniversity.nl   
Contact: I. Moll         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: R.J. Vermeulen, prof M.D. Maastricht University Medical Center

Additional Information:
Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03440632     History of Changes
Other Study ID Numbers: NL63250.068.17
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: With publishing our results, an additional data file will be available containing the original individual data (anonymized) in order to make meta-analysis possible.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: In the years 2020 and 2021.
Access Criteria: not yet known.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
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