Cerebral Palsy, CongenitalPhase 4NCT02462018
Effects of Functional Electrical Stimulation on Gait in Children With Cerebral Palsy
A Phase 4 study testing WalkAide in people with Cerebral Palsy, Congenital and Muscle Spasticity, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cerebral Palsy, Congenital, Muscle Spasticity
- What is being tested?
- WalkAide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2017
- Phase
- Phase 4
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -Children above age of 6 years, with hemiplegic and asymmetric diplegic CP GMFCS I/II, with drop foot and dynamic contracture of the ankle on examination, who are being treated at the CP clinic at Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Who cannot join
- Children with fixed contracture of ankle joint (passive range of motion< 0 degree); children who had orthopedic surgery to the leg or had botulinum toxin injection to the plantar or dorsiflexor muscles within the 6 months prior to the study; children who cannot tolerate the electrical stimulation delivered by the device.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Functional Electrical Stimulation on Gait in Children With Hemiplegic and Diplegic Cerebral Palsy
Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture.
Muscle weakness and spasticity associated with CP limit the joint range of motion and negatively impact ambulatory ability. Most ambulatory children with CP are prescribed with ankle-foot orthoses (AFOs) to improve ankle position and stability and to maintain muscle range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle weakness and atrophy.
Read more
During the last years a novel method is being used for treating upper motor neuron drop foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).
These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating the tibialis anterior muscle. Most of the studies of FES devices were conducted on adult population. These studies showed improvement in laboratory and functional gait parameters. There are relatively few studies on children with hemiplegic or diplegic CP with favorable results. There is no solid evidence whether the improvements seen in laboratory setting of children with CP, are reflected on functional ambulation in daily life. In addition, there are no defined parameters which could predict the response to FES among those children.
The aim of this study is to determine whether using FES device (WalkAide; Innovative Neurotronics, Austin, TX, USA) improves daily motor function and gait parameters in children with spastic hemiplegic or diplegic CP. additionally, we aim to define clinical and biomechanical parameters that can predict a favorable response to using the FES device.
Read the detailed description
Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture.
Individuals with CP exhibit a wide range of motor disabilities; however, approximately 70% of them achieve the ability to ambulate during childhood, albeit with difficulty.
Muscle weakness and spasticity associated with CP limit the joint range of motion and negatively impact ambulatory ability. The ankle joint is affected in virtually all patients. Insufficient ankle dorsiflexion during swing, foot drop and excessive plantar flexion during early to mid-stance may cause standing and walking instability with greater risk for falling. Most ambulatory children with CP are prescribed with ankle-foot orthoses (AFOs) to improve ankle position and stability for standing and walking and to maintain muscle range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle weakness and atrophy, leading to further loss of function over time. In addition many children, especially adolescents, avoid using AFOs because of discomfort and concerns regarding negative effects on body image.
During the last years a novel method is being used for treating upper motor neuron drop foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).
These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating the tibialis anterior muscle.
FES devices, by actively stimulating the muscle have theoretical advantages over static AFOs. In addition the stimulator can be cosmetically better accepted.
Most of the studies of FES devices were conducted on adult population with upper motor neuron defect. These studies showed improvement in laboratory and functional gait parameters.In addition to the direct orthotic effect of the device during utilization, some studies also indicated a therapeutic effect ("carry over effect"), which was postulated to arise through the neural plasticity facilitation by increasing the strength of afferent feedback inputs to CNS. Whether this therapeutic effect actually exists and for how long is still unclear.
A variety of Functional Electrical Stimulation (FES) devices are being increasingly prescribed as a treatment option in CP children. There are relatively few studies on children with hemiplegic or diplegic CP. Prosser et al(Prosser et al 2013), reported good acceptability of FES device in CP population. Other studies have showed as well favorable results, with improvement of ankle kinematics parameters, such as dorsiflexion angle at swing phase and initial contact. Damiano et al (Damiano et al 2012) showed evidence of use-dependent muscle plasticity with increased tibialis anterior muscle thickness while using FES devices in CP patients.
There is still no solid evidence whether the improvements seen in laboratory setting are reflected on functional ambulation in daily life. Some studies showed improvement in walking speed while others did not.
Moreover, some studies also indicated an effect variability among subjects, which could be partially explained by the heterogeneity of CP population. There are no defined parameters which could predict the response to FES among those children.
The WalkAide(WalkAide; Innovative Neurotronics, Austin, TX, USA) is a battery-operated, small medical electrical stimulator device, which attaches to a molded cuff located just below the knee and produces controlled dorsiflexion of the foot during walk.It utilizes a tilt sensor and accelerometer to control the timing and duration of the stimulation during walking.Use of the Tilt Sensor to trigger stimulation eliminates the need for additional components or external wires.
The aim of this study is to determine whether using WalkAide device, improves daily motor function and gait parameters in children with spastic hemiplegic or diplegic CP. In addition, we aim to define clinical and biomechanical parameters that can predict a favorable response to using the FES device.
- Conditions
- Cerebral Palsy, Congenital, Muscle Spasticity
- Being tested
- WalkAide
- Keywords
- Cerebral Palsy, Muscle Spasticity, Orthoses, Functional Electrical Stimulation, Prospective
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkAideDevice
Patiants with hemiplegic or asymmetric diplegic CP will use WalkAide device for 4 months .First month for adjustment and three months of daily using of the device.
For each patient two assessments will be conducted: at baseline and at post-intervention follow-up.
During the assessments each child will go through:
- Medical interview and neurological and physical therapist examination. B. Motor function tests: "6 min walk test", Gross motor function measure (GMFM) ,"Timed up and down stairs test" (TUDS), walking on a ramp ,with and without the FES device.
- Gait analysis test with and without FES device. D. Parents will be requested to complete questionnaires on the frequency of falling.
- On the second assessment parents wiil be requested to complete a questionnaire about the compliance to the FES.
| Study group | Role | What they receive |
|---|---|---|
| WalkAide | Experimental | Not described Receives: Device: WalkAide |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Six min walk test"
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (Maher C et al ,2008)
Measured: 4 months
"Gross motor function measure" (GMFM) section E
The Gross Motor Function Measure (GMFM) is a clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. Section E evaluate walking, running and jumping skills (Rosenbaum PL et al, 2008)
Measured: 4 months
"Timed up and down stairs test"
This test measures time going up and down 14-step flight of stairs (Zaino CA et al 2004)
Measured: 4 months
Ankle angle at initial contact
measured by "Gait analysis laboratory"
Measured: 4 months
Peak dorsiflexion angle in swing phase
measured by "Gait analysis laboratory"
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, CongenitalStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462018
- Sponsor's protocol ID
- TLV-0192-15
- Status last verified
- Apr 2015
- First submitted
- 31 May 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Prosser LA, Curatalo LA, Alter KE, Damiano DL. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2012 Nov;54(11):1044-9. doi: 10.1111/j.1469-8749.2012.04401.x. Epub 2012 Aug 27.
PubMed 22924431LIBERSON WT, HOLMQUEST HJ, SCOT D, DOW M. Functional electrotherapy: stimulation of the peroneal nerve synchronized with the swing phase of the gait of hemiplegic patients. Arch Phys Med Rehabil. 1961 Feb;42:101-5. No abstract available.
PubMed 13761879Maher CA, Williams MT, Olds TS. The six-minute walk test for children with cerebral palsy. Int J Rehabil Res. 2008 Jun;31(2):185-8. doi: 10.1097/MRR.0b013e32830150f9.
PubMed 18467936Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1.
PubMed 18318732Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A.
PubMed 17057533
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulation on Gait in Children With Hemiplegic and Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02462018
- Acronym / sponsor ID
- TLV-0192-15
- Conditions
- Cerebral Palsy, Congenital, Muscle Spasticity
- Keywords
- Cerebral Palsy, Muscle Spasticity, Orthoses, Functional Electrical Stimulation, Prospective
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 3 Jun 2015 (estimated)
- 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.
Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture.
Muscle weakness and spasticity associated with CP limit the joint range of motion and negatively impact ambulatory ability. Most ambulatory children with CP are prescribed with ankle-foot orthoses (AFOs) to improve ankle position and stability and to maintain muscle range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle weakness and atrophy.
During the last years a novel method is being used for treating upper motor neuron drop foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).
These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating the tibialis anterior muscle. Most of the studies of FES devices were conducted on adult population. These studies showed improvement in laboratory and functional gait parameters. There are relatively few studies on children with hemiplegic or diplegic CP with favorable results. There is no solid evidence whether the improvements seen in laboratory setting of children with CP, are reflected on functional ambulation in daily life. In addition, there are no defined parameters which could predict the response to FES among those children.
The aim of this study is to determine whether using FES device (WalkAide; Innovative Neurotronics, Austin, TX, USA) improves daily motor function and gait parameters in children with spastic hemiplegic or diplegic CP. additionally, we aim to define clinical and biomechanical parameters that can predict a favorable response to using the FES device.
Detailed description
Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture.
Individuals with CP exhibit a wide range of motor disabilities; however, approximately 70% of them achieve the ability to ambulate during childhood, albeit with difficulty.
Muscle weakness and spasticity associated with CP limit the joint range of motion and negatively impact ambulatory ability. The ankle joint is affected in virtually all patients. Insufficient ankle dorsiflexion during swing, foot drop and excessive plantar flexion during early to mid-stance may cause standing and walking instability with greater risk for falling. Most ambulatory children with CP are prescribed with ankle-foot orthoses (AFOs) to improve ankle position and stability for standing and walking and to maintain muscle range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle weakness and atrophy, leading to further loss of function over time. In addition many children, especially adolescents, avoid using AFOs because of discomfort and concerns regarding negative effects on body image.
During the last years a novel method is being used for treating upper motor neuron drop foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).
These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating the tibialis anterior muscle.
FES devices, by actively stimulating the muscle have theoretical advantages over static AFOs. In addition the stimulator can be cosmetically better accepted.
Most of the studies of FES devices were conducted on adult population with upper motor neuron defect. These studies showed improvement in laboratory and functional gait parameters.In addition to the direct orthotic effect of the device during utilization, some studies also indicated a therapeutic effect ("carry over effect"), which was postulated to arise through the neural plasticity facilitation by increasing the strength of afferent feedback inputs to CNS. Whether this therapeutic effect actually exists and for how long is still unclear.
A variety of Functional Electrical Stimulation (FES) devices are being increasingly prescribed as a treatment option in CP children. There are relatively few studies on children with hemiplegic or diplegic CP. Prosser et al(Prosser et al 2013), reported good acceptability of FES device in CP population. Other studies have showed as well favorable results, with improvement of ankle kinematics parameters, such as dorsiflexion angle at swing phase and initial contact. Damiano et al (Damiano et al 2012) showed evidence of use-dependent muscle plasticity with increased tibialis anterior muscle thickness while using FES devices in CP patients.
There is still no solid evidence whether the improvements seen in laboratory setting are reflected on functional ambulation in daily life. Some studies showed improvement in walking speed while others did not.
Moreover, some studies also indicated an effect variability among subjects, which could be partially explained by the heterogeneity of CP population. There are no defined parameters which could predict the response to FES among those children.
The WalkAide(WalkAide; Innovative Neurotronics, Austin, TX, USA) is a battery-operated, small medical electrical stimulator device, which attaches to a molded cuff located just below the knee and produces controlled dorsiflexion of the foot during walk.It utilizes a tilt sensor and accelerometer to control the timing and duration of the stimulation during walking.Use of the Tilt Sensor to trigger stimulation eliminates the need for additional components or external wires.
The aim of this study is to determine whether using WalkAide device, improves daily motor function and gait parameters in children with spastic hemiplegic or diplegic CP. In addition, we aim to define clinical and biomechanical parameters that can predict a favorable response to using the FES device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WalkAide | Experimental | Device: WalkAide |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -Children above age of 6 years, with hemiplegic and asymmetric diplegic CP GMFCS I/II, with drop foot and dynamic contracture of the ankle on examination, who are being treated at the CP clinic at Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Key exclusion criteria (1 listed)
- Children with fixed contracture of ankle joint (passive range of motion< 0 degree); children who had orthopedic surgery to the leg or had botulinum toxin injection to the plantar or dorsiflexor muscles within the 6 months prior to the study; children who cannot tolerate the electrical stimulation delivered by the device.
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 |
|---|---|---|
| WalkAidePatiants with hemiplegic or asymmetric diplegic CP will use WalkAide device for 4 months .First month for adjustment and three months of daily using of the device. For each patient two assessments will be conducted: at baseline and at post-intervention follow-up. During the assessments each child will go through: A. Medical interview and neurological and physical therapist examination. B. Motor function tests: "6 min walk test", Gross motor function measure (GMFM) ,"Timed up and down stairs test" (TUDS), walking on a ramp ,with and without the FES device. C. Gait analysis test with and without FES device. D. Parents will be requested to complete questionnaires on the frequency of falling. E. On the second assessment parents wiil be requested to complete a questionnaire about the compliance to the FES. | Device | WalkAide |
Primary outcome
"Six min walk test"
Time frame: 4 months
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (Maher C et al ,2008)
"Gross motor function measure" (GMFM) section E
Time frame: 4 months
The Gross Motor Function Measure (GMFM) is a clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. Section E evaluate walking, running and jumping skills (Rosenbaum PL et al, 2008)
"Timed up and down stairs test"
Time frame: 4 months
This test measures time going up and down 14-step flight of stairs (Zaino CA et al 2004)
Ankle angle at initial contact
Time frame: 4 months
measured by "Gait analysis laboratory"
Peak dorsiflexion angle in swing phase
Time frame: 4 months
measured by "Gait analysis laboratory"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 22924431Prosser LA, Curatalo LA, Alter KE, Damiano DL. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2012 Nov;54(11):1044-9. doi: 10.1111/j.1469-8749.2012.04401.x. Epub 2012 Aug 27.
- Background: PubMed 13761879LIBERSON WT, HOLMQUEST HJ, SCOT D, DOW M. Functional electrotherapy: stimulation of the peroneal nerve synchronized with the swing phase of the gait of hemiplegic patients. Arch Phys Med Rehabil. 1961 Feb;42:101-5. No abstract available.
- Background: PubMed 18467936Maher CA, Williams MT, Olds TS. The six-minute walk test for children with cerebral palsy. Int J Rehabil Res. 2008 Jun;31(2):185-8. doi: 10.1097/MRR.0b013e32830150f9.
- Background: PubMed 18318732Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1.
- Background: PubMed 17057533Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing WalkAide in people with Cerebral Palsy, Congenital and Muscle Spasticity, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviva Fatal-Valvski, MD (972-36974517, afatal@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Six min walk test" (time frame: 4 months). The study lists 5 primary outcomes in all. 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 NCT02462018, which also lists 5 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 3 Jun 2015.