Cerebral PalsyNCT03440632
Functional Electrical Stimulation During Walking in Cerebral Palsy
A study testing FES in people with Cerebral Palsy and Spastic, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Foot Drop
- What is being tested?
- FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: Functional Electrical Stimulation of the Ankle Dorsiflexors During Walking in Children With Unilateral Spastic Cerebral Palsy: a Randomized Crossover Intervention Study
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.
Read more
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.
Read the 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.
- Conditions
- Cerebral Palsy, Spastic, Foot Drop
- Being tested
- FES
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FESDevice
Functional electrical stimulation of the ankle dorsiflexors during walking, using a (superficial) neurostimulator with tilt sensor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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'. Receives: Device: FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Setting of goal(s) at start, assessment at every end of a phase: week 12, 18 and 30.
Secondary outcomes (15)
Change in participation
as measured in the Cerebral Palsy Quality of Life Questionnaire (see reference).
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in walking distance
Measured by the 6 minute walking test and the functional mobility scale (3 items, 6-point rating scale).
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in physical activity
measured by activity monitor
Measured: assessment at start and end of a phase (except for the wash-out phase): week 12 and 30.
Change in frequency of falling
measured by a questionnaire
Measured: assessment at every end of a phase: week 12, 18 and 30.
Change in stability during walking
measured by variation of center of mass and margins of stability assessed during 3D gait analysis
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in ankle dorsiflexion angle
measured in degrees during gait analysis during 3D gait analysis
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in calf muscle activation
Assessed by spasticity measurement and electromyography (EMG) during 3D gait analysis
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in ankle plantarflexion strength during walking
Calculated by net push off moments during 3D gait analysis
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in ankle dorsiflexion and plantarflexion strength
measured in Newton by handheld dynamometer
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in feelings about donning and doffing
measured by a questionnaire
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
Change in patient satisfaction
measured by a visual analogue scale with smileys (0 = unsatisfied, 6 = perfectly satisfied).
Measured: assessment at start and every end of a phase: week 12, 18 and 30.
The compliance and acceptability of FES
derived from delivered stimulations and hours of wear time in the log file
Measured: the FES devices measures this automatically during wearing; so this will happen during the 12 weeks of FES therapy
Type of brain lesion in relation to FES success
Derived from available brain imaging
Measured: 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.
Cost-effectiveness of FES
compared to conventional therapy
Measured: analysis after study completion, week 30, using the EQ-5D-Y results.
Change in health
EQ-5D-Y Questionnaire, youth version
Measured: assessment at every end of a phase: week 12, 18 and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Aug 2018
- Primary completion10 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomisation for the order of treatments and thereby for the total length of the 'conventional therapy phase'.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R.J. Vermeulen, prof M.D., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440632
- Sponsor's protocol ID
- NL63250.068.17
- Status last verified
- Sep 2021
- First submitted
- 20 Nov 2017
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: With publishing our results, an additional data file will be available containing the original individual data (anonymized) in order to make meta-analysis possible.
Publications
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.
PubMed 28815571Waters 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.
PubMed 17209977Moll 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.
PubMed 35027013
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation of the Ankle Dorsiflexors During Walking in Children With Unilateral Spastic Cerebral Palsy: a Randomized Crossover Intervention Study
- ClinicalTrials.gov ID
- NCT03440632
- Acronym / sponsor ID
- NL63250.068.17
- Conditions
- Cerebral Palsy, Spastic, Foot Drop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomisation for the order of treatments and thereby for the total length of the 'conventional therapy phase'.
| Arm | Type | Receives |
|---|---|---|
| FES start | Other | Device: FESStart: 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. |
| Conventional start | Other | Device: FESStart: 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'. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FESFunctional electrical stimulation of the ankle dorsiflexors during walking, using a (superficial) neurostimulator with tilt sensor. | Device | Conventional start, FES start |
Primary outcome
Change in goal attainment scale (GAS)
Time frame: 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.
15 secondary outcomes
Change in participation
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in walking distance
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in physical activity
Time frame: assessment at start and end of a phase (except for the wash-out phase): week 12 and 30.
Change in frequency of falling
Time frame: assessment at every end of a phase: week 12, 18 and 30.
Change in stability during walking
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in ankle dorsiflexion angle
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in calf muscle activation
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in ankle plantarflexion strength during walking
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in ankle dorsiflexion and plantarflexion strength
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in feelings about donning and doffing
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
Change in patient satisfaction
Time frame: assessment at start and every end of a phase: week 12, 18 and 30.
The compliance and acceptability of FES
Time frame: the FES devices measures this automatically during wearing; so this will happen during the 12 weeks of FES therapy
Type of brain lesion in relation to FES success
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.
Cost-effectiveness of FES
Time frame: analysis after study completion, week 30, using the EQ-5D-Y results.
Change in health
Time frame: assessment at every end of a phase: week 12, 18 and 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Background: PubMed 28815571Moll 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.
- Background: PubMed 17209977Waters 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.
- Derived from this study: PubMed 35027013Moll 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.
- Pubmed link to the reviewLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. With publishing our results, an additional data file will be available containing the original individual data (anonymized) in order to make meta-analysis possible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R.J. Vermeulen, prof M.D. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES in people with Cerebral Palsy and Spastic, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in goal attainment scale (GAS) (time frame: Setting of goal(s) at start, assessment at every end of a phase: week 12, 18 and 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440632, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.