Clinical trial NCT03440632: Functional Electrical Stimulation During Walking in Cerebral Palsy
Official title: Functional Electrical Stimulation of the Ankle Dorsiflexors During Walking in Children With Unilateral Spastic Cerebral Palsy: a Randomized Crossover Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Spastic
Foot Drop
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomisation for the order of treatments and thereby for the total length of the 'conventional therapy phase'.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in goal attainment scale (GAS)
timeFrame: Setting of goal(s) at start, assessment at every end of a phase: week 12, 18 and 30.
Secondary outcomes:
measure: Change in participation
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in walking distance
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in physical activity
timeFrame: assessment at start and end of a phase (except for the wash-out phase): week 12 and 30.
measure: Change in frequency of falling
timeFrame: assessment at every end of a phase: week 12, 18 and 30.
measure: Change in stability during walking
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in ankle dorsiflexion angle
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in calf muscle activation
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in ankle plantarflexion strength during walking
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in ankle dorsiflexion and plantarflexion strength
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in feelings about donning and doffing
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: Change in patient satisfaction
timeFrame: assessment at start and every end of a phase: week 12, 18 and 30.
measure: The compliance and acceptability of FES
timeFrame: the FES devices measures this automatically during wearing; so this will happen during the 12 weeks of FES therapy
measure: Type of brain lesion in relation to FES success
timeFrame: 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.
measure: Cost-effectiveness of FES
timeFrame: analysis after study completion, week 30, using the EQ-5D-Y results.
measure: Change in health
timeFrame: assessment at every end of a phase: week 12, 18 and 30.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: R.J. Vermeulen, prof M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moll I, Vles JSH, Soudant DLHM, Witlox AMA, Staal HM, Speth LAWM, Janssen-Potten YJM, Coenen M, Koudijs SM, Vermeulen RJ. Functional electrical stimulation of the ankle dorsiflexors during walking in spastic cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Dec;59(12):1230-1236. doi: 10.1111/dmcn.13501. Epub 2017 Aug 17.
citation: Waters E, Davis E, Mackinnon A, Boyd R, Graham HK, Kai Lo S, Wolfe R, Stevenson R, Bjornson K, Blair E, Hoare P, Ravens-Sieberer U, Reddihough D. Psychometric properties of the quality of life questionnaire for children with CP. Dev Med Child Neurol. 2007 Jan;49(1):49-55. doi: 10.1017/s0012162207000126.x.
citation: Moll I, Marcellis RGJ, Coenen MLP, Fleuren SM, Willems PJB, Speth LAWM, Witlox MA, Meijer K, Vermeulen RJ. A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial. BMC Pediatr. 2022 Jan 13;22(1):37. doi: 10.1186/s12887-021-03037-9.