Functional Electrical Stimulation During Walking in Cerebral Palsy

NCT03440632 | Completed DMC FDA Device

• 1 other identifier: NL63250.068.17
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic; Foot Drop

Outcome Measures

Primary Outcomes (1)

• Change in goal attainment scale (GAS)

  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.

  Setting of goal(s) at start, assessment at every end of a phase: week 12, 18 and 30.

Secondary Outcomes (15)

• Change in participation

  assessment at start and every end of a phase: week 12, 18 and 30.

• Change in walking distance

  assessment at start and every end of a phase: week 12, 18 and 30.

• Change in physical activity

  assessment at start and end of a phase (except for the wash-out phase): week 12 and 30.

• Change in frequency of falling

  assessment at every end of a phase: week 12, 18 and 30.

• Change in stability during walking

  assessment at start and every end of a phase: week 12, 18 and 30.

Study Arms (2)

FES start

OTHER

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

Conventional start

OTHER

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

Interventions

FES DEVICE

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

Conventional start; FES start

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 28815571 BACKGROUND

• 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.

  PMID: 17209977 BACKGROUND

• 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.

  PMID: 35027013 DERIVED

Related Links

• Pubmed link to the review

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Peroneal Neuropathies

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; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• R.J. Vermeulen, prof M.D.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physical examination and the advanced analysis of the 3D gait analysis will be done be a blinded examiner.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: February 22, 2018
• Study Start: August 1, 2018
• Primary Completion: September 10, 2021
• Study Completion: September 30, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: In the years 2020 and 2021.
• Access Criteria: not yet known.

Locations

NL (1)