Cerebral PalsyNCT04290689
Can Gait Analysis and Ultrasound Detect a Change in Calf Musculature in Children With Cerebral Palsy?
An observational study of Cerebral Palsy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
ORLAU is a clinical department of the Robert Jones and Agnes Hunt Orthopaedic Hospital. We treat patients with a wide range of movement disorders affecting their walking or arm function. One of the most common gait issues we see is toe-walking, this is most prevalent in those patients with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botulinum Toxin-A injection and Serial casting stretching
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2018to Dec 2022
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Potential participants will be screened by the research team at weekly review meeting (involving the Medical Director and orthopaedic consultants). Participants will be identified in the Childrens outpatient's clinics at Trust Hospital (RJAH).
Who may be able to join
- Participants must be diagnosed with Cerebral Palsy and have a planned intervention of serial casting or botulinum toxin calf injection or serial casting and botulinum toxin injection.
- Participants must be able to walk 10 metres barefoot.
- Participants must be between the ages of 4 and 16.
- Participants must have a gait pattern showing persistent toe walking or premature heel rise.
- Participants should be able to comply with requests to walk in the gait laboratory.
Who cannot join
- Participants who have had Botulinum toxin-A calf injections or previous serial casting within the last 6 months.
- Participants should not have fixed foot equinus.
- Participants must not have any learning difficulties which would prevent compliance with the standard protocols.
- Participants must not have had any previous surgical interventions of the lower limbs within one year of taking of taking part.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
ORLAU, RJAH Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG
Caroline Stewart, PhD, 0044 1691 404666, caroline.stewart9@nhs.net
Claire Wright, 0044 1691 404139, clairewright8@nhs.net
About this study
Official title: Can Gait Analysis and Imaging Methods Detect Change in the Calf Musculature in Children With Cerebral Palsy? Comparison Study of Toe Walking Patients Following Serial Casting, Botulinum Toxin-A and Typically Developing Controls.
ORLAU is a clinical department of the Robert Jones and Agnes Hunt Orthopaedic Hospital. We treat patients with a wide range of movement disorders affecting their walking or arm function. One of the most common gait issues we see is toe-walking, this is most prevalent in those patients with cerebral palsy (CP). Toe-walking in CP children arises mostly from problems in the calf muscle, we currently use gait analysis to help guide treatment management plans. Two standard interventions for such cases are serial casting and Botulinum Toxin-A injections. Using gait analysis we will be able to see changes to the gait pattern before and after the interventions, however, we want to obtain a whole clinical picture, using B-mode ultrasound, elastography and electromyography (EMG) we will be able to achieve this. These measurements will provide us with information about the muscle architecture and properties including activation. This will help us to determine the effects of the interventions. Elastography is a fairly new clinical technique that uses shear waves generated by the ultrasound probe to map the stiffness of a muscle. Stiffness of muscle is a good indication of myopathies. The additional examinations we want to carry out are all non-invasive, they will be carried out in two sessions, one before the intervention and one after. We will compare the data we collect from the children with CP to our normal database with ORLAU has ethical approval for. The final stage of this study will be to use the muscle parameters obtained by ultrasound to set parameters in a computer musculoskeletal model.
Read the detailed description
The aim of this study is to investigate the impact on gait and morphology of the calf muscle in children with Cerebral Palsy with equinus gait pattern following serial casting and Botulinum toxin (Btx) interventions.
Toe walking is a common feature of a number of orthopaedic and neurological problems (e.g. cerebral palsy, idiopathic toe walking and stroke). Patients who toe walk often develop contractures in their calf muscles and in the longer term may suffer from foot or calf pain and foot deformities. Toe walking also causes difficulties with balance and leads to secondary compensations and deformities. The causes of toe walking are not always clear for individual patients. Current interventions target the perceived causes (e.g. surgery, stretching or orthotics for contracture or botulinum toxin injections for excessive activity) but the relationship between toe walking and the impairment in muscle morphology and control is not fully understood. Clinical movement analysis is used to quantify joint motion and loading during gait. This is done according to established local departmental protocol and is part of routine clinical practice. This is done using the Video Based Motion Analysis System Ltd (VICON), which is a 3D movement analysis modality which makes use of small, spherical reflective markers, between 5mm and 25mm in diameter that are attached to the skin over key anatomical landmarks (located during the clinical examination). Special infrared cameras are used to track the movements of reflective markers in three dimensions. This is combined with AMTI force plates; which together give the kinematics and kinetics of the subject. Electromyography (EMG) of the Triceps Surae and Tibialis Anterior enables observation of muscle activity in conjunction with the gait cycle during different movements. After obtaining participant consent and ensuring that the participant fully understands the scope of the tasks, the session is undertaken. In brief, using local ORLAU department protocol, a clinician places reflective markers on the subject and anthropometric measurements are taken. After the subject is prepared, they are asked to walk along a 10-metre walkway at a self selected speed and a minimum of 6 trials are collected with adequate strikes with each foot landing on the force plate to obtain desired kinematic and kinetic data. EMG recordings are performed simultaneously on the Medial \& Lateral Gastrocnemius, Soleus, and Tibialis Anterior to record muscle activity during the movement.
To obtain information about the morphology, the modality of B-mode ultrasound evaluated the muscle morphology and obtains key information such as muscle fibre length, fibre orientation, pennation angle, cross sectional area, and muscle thickness. After obtaining consent and ensuring that the participant understands fully the scope of the session, they are asked to lie prone on the plinth with lower legs exposed so that the assessor has access to the calf muscles. The assessor then uses the b-mode ultrasound protocol to obtain the key parameters of the calf muscle. Muscle lengths are measured using a Vernier caliper.
In addition, the imaging modality elastography is used. This uses mechanical force, from manual pressure or through a shear wave impulse generated within the ultrasound probe, to detect the change in deformation of the examined tissue and therefore to determine the stiffness. The stiffness of soft tissues can be an indication of pathology. Elastography uses harmless ultrasound waves and allows for the visualisation of strain across a tissue, by superimposing the colour coded elasticity map onto a conventional B-mode image. The colours represent the stiffness of the tissue ranging from red to green to blue, with the exact scale varying between vendors. Shear wave elastography has the added advantage of being able to provide velocity measurements within a defined region of interest, thus quantifying tissue stiffness.
Prior to beginning the session, consent from the subject is obtained and the scope of the session is explained. After consent from the participant, the subject is asked to lie prone on the plinth with their lower legs exposed. The consultant radiologist undertakes elastography measures on the calf muscles (medial, lateral gastrocnemius, soleus) in longitudinal and transverse planes according to the protocol. These are then saved after the key information is obtained and analysed after the session.
Computer modelling can estimate muscle forces during gait, and it is used to study a wide range of conditions such as spastic paresis and crouch gait. Ultrasound can provide information about muscle parameters such as volume, length, anatomical cross-sectional area and pennation angle. This information can be used to adjust the parameters of the musculoskeletal model to fit the characteristics of each patient. The musculoskeletal model can then estimate personalised muscle forces and help understand the individual impairments which lead to toe walking. Future prospects Clinical- The computer models will assist with the precise identification of impairments (eg muscle atrophy, contracture and spasticity) and hence allow more objective specification and targeting of interventions. Combining the data collected from B mode ultrasound, elastography and gait analysis, the effects of clinical interventions in muscle properties can be observed. This can be applied to other interventions, including orthopaedic surgery and orthotic devices. Elastography can also be a vital tool in understanding the elastic muscle properties associated with myopathies and can help optimise and personalise care by selecting the most effective intervention based on an individual's baseline features.
- Conditions
- Cerebral Palsy
- Being tested
- Botulinum Toxin-A injection, Serial casting stretching
- Keywords
- cerebral palsy, b-mode ultrasound, gait analysis, EMG, elastography, musculoskeletal modelling
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin-A injectionDrug
Also called "Botox"
Botulinum Toxin-A injection to be administered by the surgeon to the subject's calf muscle as per normal clinical protocol to help improve muscle tone.
Serial casting stretchingProcedure or surgery
Also called serial cast
Stretching cast intervention to be carried out in clinic as per normal clinical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin-A injection treatment | Toe walking Cerebral Palsy subject who are subject to Botulinum toxin-A injection treatment. The dosage will be determined by the Orthopaedic Consultant Receives: Drug: Botulinum Toxin-A injection | |
| Serial casting stretching treatment | Toe walking Cerebral Palsy subject who are subject to serial casting stretching treatment. Receives: Procedure: Serial casting stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Are there gait (kinetic) differences pre and post intervention in toe walking cerebral palsy subjects?
Kinetics (joint forces) will be measured (using gait analysis modality) pre and post intervention in toe walking cerebral palsy subjects. The intervention will be determined by the consultant Orthopedic Surgeon in clinic.Units of measure:measured in Nm/kg
Measured: up to12 weeks
Are there gait (kinematic) differences pre and post intervention in toe walking cerebral palsy subjects?
Kinematics (joint angles) will be measured (using gait analysis modality) pre and post intervention in toe walking cerebral palsy subjects. The intervention will be determined by the consultant Orthopedic Surgeon in clinic.Units of measure: measured in degrees (angle).
Measured: up to 12 weeks
Triceps Surae muscle activation during the gait cycle (Electromyography)
Electromyography (EMG) measurement - is the muscle activated or deactivated pre and post intervention in toe walking cerebral palsy subjects? Measured in uV
Measured: up to12 weeks
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle thickness. Measured in millimeter
Measured: up to 12 weeks
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle fibre length; measured in millimeter
Measured: up to 12 weeks
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle length; measured in millimeter
Measured: up to 12 weeks
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - pennation angle; measured in degrees.
Measured: up to 12 weeks
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - Cross sectional area; measured in cm^2
Measured: up to 12 weeks
Difference in the muscle stiffness values (using elastography) in the calf muscle pre and post intervention.
To determine, using elastography modality, if there is a difference in muscle stiffness values pre and post intervention for toe walking cerebral palsy children. Units of measure: m/s velocity
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start14 Mar 2018
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290689
- Sponsor's protocol ID
- RL1 777
- Status last verified
- Feb 2022
- First submitted
- 29 Oct 2019
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study is still recruiting and collecting data. sharing will depend on the quality and quantity of data collected.
Publications
Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
PubMed 28698802Barber L, Barrett R, Lichtwark G. Passive muscle mechanical properties of the medial gastrocnemius in young adults with spastic cerebral palsy. J Biomech. 2011 Sep 2;44(13):2496-500. doi: 10.1016/j.jbiomech.2011.06.008. Epub 2011 Jul 16.
PubMed 21762920Blemker SS, Asakawa DS, Gold GE, Delp SL. Image-based musculoskeletal modeling: applications, advances, and future opportunities. J Magn Reson Imaging. 2007 Feb;25(2):441-51. doi: 10.1002/jmri.20805.
PubMed 17260405Stewart C, Shortland AP. The biomechanics of pathological gait - from muscle to movement. Acta Bioeng Biomech. 2010;12(3):3-12.
PubMed 21247058Kalsi G, Fry NR, Shortland AP. Gastrocnemius muscle-tendon interaction during walking in typically-developing adults and children, and in children with spastic cerebral palsy. J Biomech. 2016 Oct 3;49(14):3194-3199. doi: 10.1016/j.jbiomech.2016.07.038. Epub 2016 Aug 8.
PubMed 27545082
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Gait Analysis and Imaging Methods Detect Change in the Calf Musculature in Children With Cerebral Palsy? Comparison Study of Toe Walking Patients Following Serial Casting, Botulinum Toxin-A and Typically Developing Controls.
- ClinicalTrials.gov ID
- NCT04290689
- Acronym / sponsor ID
- RL1 777
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, b-mode ultrasound, gait analysis, EMG, elastography, musculoskeletal modelling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Mar 2020 (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.
ORLAU is a clinical department of the Robert Jones and Agnes Hunt Orthopaedic Hospital. We treat patients with a wide range of movement disorders affecting their walking or arm function. One of the most common gait issues we see is toe-walking, this is most prevalent in those patients with cerebral palsy (CP). Toe-walking in CP children arises mostly from problems in the calf muscle, we currently use gait analysis to help guide treatment management plans. Two standard interventions for such cases are serial casting and Botulinum Toxin-A injections. Using gait analysis we will be able to see changes to the gait pattern before and after the interventions, however, we want to obtain a whole clinical picture, using B-mode ultrasound, elastography and electromyography (EMG) we will be able to achieve this. These measurements will provide us with information about the muscle architecture and properties including activation. This will help us to determine the effects of the interventions. Elastography is a fairly new clinical technique that uses shear waves generated by the ultrasound probe to map the stiffness of a muscle. Stiffness of muscle is a good indication of myopathies. The additional examinations we want to carry out are all non-invasive, they will be carried out in two sessions, one before the intervention and one after. We will compare the data we collect from the children with CP to our normal database with ORLAU has ethical approval for. The final stage of this study will be to use the muscle parameters obtained by ultrasound to set parameters in a computer musculoskeletal model.
Detailed description
The aim of this study is to investigate the impact on gait and morphology of the calf muscle in children with Cerebral Palsy with equinus gait pattern following serial casting and Botulinum toxin (Btx) interventions.
Toe walking is a common feature of a number of orthopaedic and neurological problems (e.g. cerebral palsy, idiopathic toe walking and stroke). Patients who toe walk often develop contractures in their calf muscles and in the longer term may suffer from foot or calf pain and foot deformities. Toe walking also causes difficulties with balance and leads to secondary compensations and deformities. The causes of toe walking are not always clear for individual patients. Current interventions target the perceived causes (e.g. surgery, stretching or orthotics for contracture or botulinum toxin injections for excessive activity) but the relationship between toe walking and the impairment in muscle morphology and control is not fully understood. Clinical movement analysis is used to quantify joint motion and loading during gait. This is done according to established local departmental protocol and is part of routine clinical practice. This is done using the Video Based Motion Analysis System Ltd (VICON), which is a 3D movement analysis modality which makes use of small, spherical reflective markers, between 5mm and 25mm in diameter that are attached to the skin over key anatomical landmarks (located during the clinical examination). Special infrared cameras are used to track the movements of reflective markers in three dimensions. This is combined with AMTI force plates; which together give the kinematics and kinetics of the subject. Electromyography (EMG) of the Triceps Surae and Tibialis Anterior enables observation of muscle activity in conjunction with the gait cycle during different movements. After obtaining participant consent and ensuring that the participant fully understands the scope of the tasks, the session is undertaken. In brief, using local ORLAU department protocol, a clinician places reflective markers on the subject and anthropometric measurements are taken. After the subject is prepared, they are asked to walk along a 10-metre walkway at a self selected speed and a minimum of 6 trials are collected with adequate strikes with each foot landing on the force plate to obtain desired kinematic and kinetic data. EMG recordings are performed simultaneously on the Medial \& Lateral Gastrocnemius, Soleus, and Tibialis Anterior to record muscle activity during the movement.
To obtain information about the morphology, the modality of B-mode ultrasound evaluated the muscle morphology and obtains key information such as muscle fibre length, fibre orientation, pennation angle, cross sectional area, and muscle thickness. After obtaining consent and ensuring that the participant understands fully the scope of the session, they are asked to lie prone on the plinth with lower legs exposed so that the assessor has access to the calf muscles. The assessor then uses the b-mode ultrasound protocol to obtain the key parameters of the calf muscle. Muscle lengths are measured using a Vernier caliper.
In addition, the imaging modality elastography is used. This uses mechanical force, from manual pressure or through a shear wave impulse generated within the ultrasound probe, to detect the change in deformation of the examined tissue and therefore to determine the stiffness. The stiffness of soft tissues can be an indication of pathology. Elastography uses harmless ultrasound waves and allows for the visualisation of strain across a tissue, by superimposing the colour coded elasticity map onto a conventional B-mode image. The colours represent the stiffness of the tissue ranging from red to green to blue, with the exact scale varying between vendors. Shear wave elastography has the added advantage of being able to provide velocity measurements within a defined region of interest, thus quantifying tissue stiffness.
Prior to beginning the session, consent from the subject is obtained and the scope of the session is explained. After consent from the participant, the subject is asked to lie prone on the plinth with their lower legs exposed. The consultant radiologist undertakes elastography measures on the calf muscles (medial, lateral gastrocnemius, soleus) in longitudinal and transverse planes according to the protocol. These are then saved after the key information is obtained and analysed after the session.
Computer modelling can estimate muscle forces during gait, and it is used to study a wide range of conditions such as spastic paresis and crouch gait. Ultrasound can provide information about muscle parameters such as volume, length, anatomical cross-sectional area and pennation angle. This information can be used to adjust the parameters of the musculoskeletal model to fit the characteristics of each patient. The musculoskeletal model can then estimate personalised muscle forces and help understand the individual impairments which lead to toe walking. Future prospects Clinical- The computer models will assist with the precise identification of impairments (eg muscle atrophy, contracture and spasticity) and hence allow more objective specification and targeting of interventions. Combining the data collected from B mode ultrasound, elastography and gait analysis, the effects of clinical interventions in muscle properties can be observed. This can be applied to other interventions, including orthopaedic surgery and orthotic devices. Elastography can also be a vital tool in understanding the elastic muscle properties associated with myopathies and can help optimise and personalise care by selecting the most effective intervention based on an individual's baseline features.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin-A injection treatment | – | Drug: Botulinum Toxin-A injectionToe walking Cerebral Palsy subject who are subject to Botulinum toxin-A injection treatment. The dosage will be determined by the Orthopaedic Consultant |
| Serial casting stretching treatment | – | Procedure: Serial casting stretchingToe walking Cerebral Palsy subject who are subject to serial casting stretching treatment. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Potential participants will be screened by the research team at weekly review meeting (involving the Medical Director and orthopaedic consultants). Participants will be identified in the Childrens outpatient's clinics at Trust Hospital (RJAH).
Key inclusion criteria (5 listed)
- Participants must be diagnosed with Cerebral Palsy and have a planned intervention of serial casting or botulinum toxin calf injection or serial casting and botulinum toxin injection.
- Participants must be able to walk 10 metres barefoot.
- Participants must be between the ages of 4 and 16.
- Participants must have a gait pattern showing persistent toe walking or premature heel rise.
- Participants should be able to comply with requests to walk in the gait laboratory.
Key exclusion criteria (4 listed)
- Participants who have had Botulinum toxin-A calf injections or previous serial casting within the last 6 months.
- Participants should not have fixed foot equinus.
- Participants must not have any learning difficulties which would prevent compliance with the standard protocols.
- Participants must not have had any previous surgical interventions of the lower limbs within one year of taking of taking part.
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 |
|---|---|---|
| Botulinum Toxin-A injectionAlso: "Botox"Botulinum Toxin-A injection to be administered by the surgeon to the subject's calf muscle as per normal clinical protocol to help improve muscle tone. | Drug | Botulinum Toxin-A injection treatment |
| Serial casting stretchingAlso: serial castStretching cast intervention to be carried out in clinic as per normal clinical protocol. | Procedure or surgery | Serial casting stretching treatment |
Primary outcome
Are there gait (kinetic) differences pre and post intervention in toe walking cerebral palsy subjects?
Time frame: up to12 weeks
Kinetics (joint forces) will be measured (using gait analysis modality) pre and post intervention in toe walking cerebral palsy subjects. The intervention will be determined by the consultant Orthopedic Surgeon in clinic.Units of measure:measured in Nm/kg
Are there gait (kinematic) differences pre and post intervention in toe walking cerebral palsy subjects?
Time frame: up to 12 weeks
Kinematics (joint angles) will be measured (using gait analysis modality) pre and post intervention in toe walking cerebral palsy subjects. The intervention will be determined by the consultant Orthopedic Surgeon in clinic.Units of measure: measured in degrees (angle).
Triceps Surae muscle activation during the gait cycle (Electromyography)
Time frame: up to12 weeks
Electromyography (EMG) measurement - is the muscle activated or deactivated pre and post intervention in toe walking cerebral palsy subjects? Measured in uV
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
Time frame: up to 12 weeks
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle thickness. Measured in millimeter
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
Time frame: up to 12 weeks
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle fibre length; measured in millimeter
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
Time frame: up to 12 weeks
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle length; measured in millimeter
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
Time frame: up to 12 weeks
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - pennation angle; measured in degrees.
Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?
Time frame: up to 12 weeks
B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - Cross sectional area; measured in cm^2
Difference in the muscle stiffness values (using elastography) in the calf muscle pre and post intervention.
Time frame: up to 12 weeks
To determine, using elastography modality, if there is a difference in muscle stiffness values pre and post intervention for toe walking cerebral palsy children. Units of measure: m/s velocity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 28698802Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
- Background: PubMed 21762920Barber L, Barrett R, Lichtwark G. Passive muscle mechanical properties of the medial gastrocnemius in young adults with spastic cerebral palsy. J Biomech. 2011 Sep 2;44(13):2496-500. doi: 10.1016/j.jbiomech.2011.06.008. Epub 2011 Jul 16.
- Background: PubMed 17260405Blemker SS, Asakawa DS, Gold GE, Delp SL. Image-based musculoskeletal modeling: applications, advances, and future opportunities. J Magn Reson Imaging. 2007 Feb;25(2):441-51. doi: 10.1002/jmri.20805.
- Background: PubMed 21247058Stewart C, Shortland AP. The biomechanics of pathological gait - from muscle to movement. Acta Bioeng Biomech. 2010;12(3):3-12.
- Background: PubMed 27545082Kalsi G, Fry NR, Shortland AP. Gastrocnemius muscle-tendon interaction during walking in typically-developing adults and children, and in children with spastic cerebral palsy. J Biomech. 2016 Oct 3;49(14):3194-3199. doi: 10.1016/j.jbiomech.2016.07.038. Epub 2016 Aug 8.
- Individual participant dataSharing planned: Undecided. Study is still recruiting and collecting data. sharing will depend on the quality and quantity of data collected.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Feb 2022. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Are there gait (kinetic) differences pre and post intervention in toe walking cerebral palsy subjects? (time frame: up to12 weeks). The study lists 9 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 NCT04290689, 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 11 Feb 2022.