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Functional Electrical Stimulation During Walking in Cerebral Palsy

Functional Electrical Stimulation of the Ankle Dorsiflexors During Walking in Children With Unilateral Spastic Cerebral Palsy: a Randomized Crossover Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03440632
Enrollment
25
Registered
2018-02-22
Start date
2018-08-01
Completion date
2021-09-30
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Spastic, Foot Drop

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.

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.

Interventions

DEVICEFES

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

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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.

Intervention model description

randomisation for the order of treatments and thereby for the total length of the 'conventional therapy phase'.

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in goal attainment scale (GAS)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

MeasureTime frameDescription
Change in participationassessment 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).
Change in walking distanceassessment 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).
Change in physical activityassessment at start and end of a phase (except for the wash-out phase): week 12 and 30.measured by activity monitor
Change in frequency of fallingassessment at every end of a phase: week 12, 18 and 30.measured by a questionnaire
Change in stability during walkingassessment 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
Change in ankle dorsiflexion angleassessment at start and every end of a phase: week 12, 18 and 30.measured in degrees during gait analysis during 3D gait analysis
Change in calf muscle activationassessment at start and every end of a phase: week 12, 18 and 30.Assessed by spasticity measurement and electromyography (EMG) during 3D gait analysis
Change in patient satisfactionassessment 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).
Change in ankle dorsiflexion and plantarflexion strengthassessment at start and every end of a phase: week 12, 18 and 30.measured in Newton by handheld dynamometer
Change in feelings about donning and doffingassessment at start and every end of a phase: week 12, 18 and 30.measured by a questionnaire
The compliance and acceptability of FESthe FES devices measures this automatically during wearing; so this will happen during the 12 weeks of FES therapyderived from delivered stimulations and hours of wear time in the log file
Type of brain lesion in relation to FES successAssessment 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
Cost-effectiveness of FESanalysis after study completion, week 30, using the EQ-5D-Y results.compared to conventional therapy
Change in healthassessment at every end of a phase: week 12, 18 and 30.EQ-5D-Y Questionnaire, youth version
Change in ankle plantarflexion strength during walkingassessment at start and every end of a phase: week 12, 18 and 30.Calculated by net push off moments during 3D gait analysis

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026