Functional Electrical Stimulation During Walking in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440632
• Other study ID #: NL63250.068.17
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 30, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Foot Drop
• Muscle Spasticity
• Peroneal Neuropathies
• Spastic

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in participation	as measured in the Cerebral Palsy Quality of Life Questionnaire (see reference).	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in walking distance	Measured by the 6 minute walking test and the functional mobility scale (3 items, 6-point rating scale).	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in physical activity	measured by activity monitor	assessment at start and end of a phase (except for the wash-out phase): week 12 and 30.
Secondary	Change in frequency of falling	measured by a questionnaire	assessment at every end of a phase: week 12, 18 and 30.
Secondary	Change in stability during walking	measured by variation of center of mass and margins of stability assessed during 3D gait analysis	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in ankle dorsiflexion angle	measured in degrees during gait analysis during 3D gait analysis	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in calf muscle activation	Assessed by spasticity measurement and electromyography (EMG) during 3D gait analysis	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in ankle plantarflexion strength during walking	Calculated by net push off moments during 3D gait analysis	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in ankle dorsiflexion and plantarflexion strength	measured in Newton by handheld dynamometer	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in feelings about donning and doffing	measured by a questionnaire	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	Change in patient satisfaction	measured by a visual analogue scale with smileys (0 = unsatisfied, 6 = perfectly satisfied).	assessment at start and every end of a phase: week 12, 18 and 30.
Secondary	The compliance and acceptability of FES	derived from delivered stimulations and hours of wear time in the log file	the FES devices measures this automatically during wearing; so this will happen during the 12 weeks of FES therapy
Secondary	Type of brain lesion in relation to FES success	Derived from available brain imaging	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.
Secondary	Cost-effectiveness of FES	compared to conventional therapy	analysis after study completion, week 30, using the EQ-5D-Y results.
Secondary	Change in health	EQ-5D-Y Questionnaire, youth version	assessment at every end of a phase: week 12, 18 and 30.

External Links

•   Pubmed link to the review