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Functional Electrical Stimulation During Walking in Cerebral Palsy

Primary Purpose

Cerebral Palsy, Spastic, Foot Drop

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FES
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

FES start

Conventional start

Arm Description

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.

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'.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in participation
as measured in the Cerebral Palsy Quality of Life Questionnaire (see reference).
Change in walking distance
Measured by the 6 minute walking test and the functional mobility scale (3 items, 6-point rating scale).
Change in physical activity
measured by activity monitor
Change in frequency of falling
measured by a questionnaire
Change in stability during walking
measured by variation of center of mass and margins of stability assessed during 3D gait analysis
Change in ankle dorsiflexion angle
measured in degrees during gait analysis during 3D gait analysis
Change in calf muscle activation
Assessed by spasticity measurement and electromyography (EMG) during 3D gait analysis
Change in ankle plantarflexion strength during walking
Calculated by net push off moments during 3D gait analysis
Change in ankle dorsiflexion and plantarflexion strength
measured in Newton by handheld dynamometer
Change in feelings about donning and doffing
measured by a questionnaire
Change in patient satisfaction
measured by a visual analogue scale with smileys (0 = unsatisfied, 6 = perfectly satisfied).
The compliance and acceptability of FES
derived from delivered stimulations and hours of wear time in the log file
Type of brain lesion in relation to FES success
Derived from available brain imaging
Cost-effectiveness of FES
compared to conventional therapy
Change in health
EQ-5D-Y Questionnaire, youth version

Full Information

First Posted
November 20, 2017
Last Updated
October 1, 2021
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03440632
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Foot Drop

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomisation for the order of treatments and thereby for the total length of the 'conventional therapy phase'.
Masking
Outcomes Assessor
Masking Description
The physical examination and the advanced analysis of the 3D gait analysis will be done be a blinded examiner.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R.J. Vermeulen, prof M.D.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
In the years 2020 and 2021.
IPD Sharing Access Criteria
not yet known.
Citations:
PubMed Identifier
28815571
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.
Results Reference
background
PubMed Identifier
17209977
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.
Results Reference
background
PubMed Identifier
35027013
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28815571
Description
Pubmed link to the review

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Functional Electrical Stimulation During Walking in Cerebral Palsy

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