Cerebral PalsyNCT05447299
Neuromusculoskeletal Modeling of Muscle Spasticity
An observational study of Cerebral Palsy and Musculoskeletal Deformity, run by Region Stockholm at 1 site in Sweden.
Trial summary
Cerebral palsy (CP) is a movement and posture disorder caused by an injury to the developing brain, with a prevalence in Sweden of about 2/1000 live births. Children with CP have walking difficulties, and decreased muscle mass and muscle function as compared to typically developing (TD) children. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Musculoskeletal Deformity, Spasticity
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2019to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- Child, Adult
Study population: Participants with spastic CP are recruited from the Dept of Pediatric Orthopaedics, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden. The TD children are recruited from siblings of the participants with CP, and friends and family of the research group.
Who may be able to join
- Unilateral/Bilateral spastic CP without Botulinum toxin injection history
- Understanding study protocol and expressing voluntary consent of the family
- Dorsiflexion to at least a neutral position of the foot
Who cannot join
- Contraindication to MRI scanning: metal fragments in the body, surgically implanted devices containing metal, severe claustrophobia, or inability to lie down in the MRI scanner, presence of pacemaker or other stimulators, shunts etc.
- Total range of ankle movement less than 35°
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neurobiomekaniska Modeller av Spasticitet Med hjälp av Personspecifika Muskelparametrar
Cerebral palsy (CP) is a movement and posture disorder caused by an injury to the developing brain, with a prevalence in Sweden of about 2/1000 live births. Children with CP have walking difficulties, and decreased muscle mass and muscle function as compared to typically developing (TD) children. The extent of disability in CP depends on the severity and timing of the primary cerebral lesion and can be classified with the gross motor function classification system (GMFCS E\&R) that ranges from walking without limitations (I) to being transported in a wheelchair (V).
Muscle function commonly deteriorates with age and contracture development is often clinically evident as early as at 4 years of age. In addition to being thinner and weaker, skeletal muscle in children with CP develop poor quality, i.e., increasingly higher amounts of fat and connective tissue at the expense of functional, contractile proteins.
Read more
How long-term standard treatments for children with spastic CP including, training and orthotics use, with botulinum toxin (BoNT-A) treatment as an adjunct, affects muscle on functional, structural, and microscopic level in CP has not yet been published. Therefore, we will investigate the muscle function as well as functional mobility, structure, and spasticity. We will conduct functional mobility tests. Muscle strength will be measured with a rig-fixed dynamometer, and muscle structure will be measured with magnetic resonance imaging. The spasticity will be instrumentally assessed by the NeuroflexorTM, a machine measuring resistance in a muscle when a pedal is passively moving the participants foot at two different speeds. We will follow participants, for 1 year, with 4 measurements during this period.
In order to better treat these children, we need to better understand the complex, interrelated interactions of musculoskeletal properties and function in children with CP. Our hypothesis is that muscle structure and function is affected by standard clinical treatments sessions including routine botulinum toxin treatment. Analyzing the effect of standard care may help planning of more effective clinical treatments in the future.
Read the detailed description
How long-term standard treatments for children with spastic cerebral palsy (CP), including training and orthotics use, with botulinum toxin (BoNT-A) treatment as an adjunct, affects muscle on functional, structural, and microscopic level in CP has not yet been published. Therefore, we will investigate the muscle function as well as functional mobility, structure, and spasticity.
Research questions:
- How is muscle structure, muscle strength, spasticity and, stiffness of the calf muscle in CP related to motor function, and how does it differ to typically developing (TD) children?
- What is the long-term effect of a standard care with BoNT-A as an adjunct on motor function, muscle structure, muscle strength, spasticity, and stiffness?
Participants with spastic CP, aged between 5-17 years, are recruited from the Dept of Pediatric Orthopaedics, when clinically motivated plans for the first BoNT-A treatment session of the calf (plantar flexors) are set. Typically developing children at same ages are recruited through convenient sample and will take part of the assessments once. The children with CP will go through the following assessments at four different time-points; before, 3 months, 6 months, and one year after the first BoNT-A injection:
- Spasticity will be measured with clinical tests: Modified Tardieu scale and Modified Ashworth scale and with a instrumented device measuring muscle resistance, the NeuroflexorTM.
- Isometric strength measurements of plantar flexors and ankle dorsiflexors using a dynamometer (ChatillonTM) fixed in a custom-built testing frame while surface EMG is captured.
- Functional mobility in walking for example the Timed-Up-and-Go test (TUG-test) i.e. the time it takes for the child to stand up from a chair, walk 3 m, turn around, walk back, and sit down.
- Active and passive range of motion (ROM) measured with a goniometer
Before the first injection, the children with CP will be examined with magnetic resonance imaging (MRI) providing complex 3D structural information of individual muscles. One year after first injection, another examination with MRI will be conducted.
This explorative, observational, prospective, long time follow up study will be conducted at the Motion analysis laboratory at Astrid Lindgren's children's hospital and Huddinge Karolinska in collaboration with KTH Royal Institute of Technology.
Parametric and/or non-parametric statistical tests for within and between group comparisons, and correlations will be performed. Based on the pilot data from TD children the CP group and previous literature we need a sample size of 10-15 participants in each group.
- Conditions
- Cerebral Palsy, Musculoskeletal Deformity, Spasticity, Muscle Strength, Walking, Difficulty
- Keywords
- Spastic cerebral palsy, Muscle function, Hyper-resistance, Functional mobility
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Typically developing children | Reference group of typically developing children | |
| Cerebral palsy group | Children with a diagnosis of cerebral palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle structure
MRI based examinations including muscle volume
Measured: Before and one year after the first treatment session
Change in spasticity
Resistance at slow and fast passive movements of the foot
Measured: Before, three months, six months and 12 months after the firstt treatment session
Change in muscle strength
Muscle strength measured as force with a dynamomter in the calf muscle
Measured: Before, three months, six months and 12 months after the first treatment session
Change in functional mobility during walking
Time to complete a test of functional mobility during walking will be measured
Measured: Before, three months, six months and 12 months after the first treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Jan 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska University Hospital, KTH Royal Institute of Technology, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- R Wang, Ing, PhD, Principal investigator, KTH Royal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447299
- Sponsor's protocol ID
- K 0000-0001
- Status last verified
- Apr 2022
- First submitted
- 13 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahblom A, Ponten E, Destro A, Petersson S, von Walden F, Wang R, Lidbeck C. Exploration of the triceps surae muscle in ambulatory children with cerebral palsy using instrumented measurements of stiffness and diffusion tensor magnetic resonance imaging for muscle architecture. BMC Musculoskelet Disord. 2024 Oct 11;25(1):803. doi: 10.1186/s12891-024-07890-4.
PubMed 39394126
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiomekaniska Modeller av Spasticitet Med hjälp av Personspecifika Muskelparametrar
- ClinicalTrials.gov ID
- NCT05447299
- Acronym / sponsor ID
- K 0000-0001
- Conditions
- Cerebral Palsy, Musculoskeletal Deformity, Spasticity, Muscle Strength, Walking, Difficulty
- Keywords
- Spastic cerebral palsy, Muscle function, Hyper-resistance, Functional mobility
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska University Hospital, KTH Royal Institute of Technology, Karolinska Institutet
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 7 Jul 2022 (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.
Cerebral palsy (CP) is a movement and posture disorder caused by an injury to the developing brain, with a prevalence in Sweden of about 2/1000 live births. Children with CP have walking difficulties, and decreased muscle mass and muscle function as compared to typically developing (TD) children. The extent of disability in CP depends on the severity and timing of the primary cerebral lesion and can be classified with the gross motor function classification system (GMFCS E\&R) that ranges from walking without limitations (I) to being transported in a wheelchair (V).
Muscle function commonly deteriorates with age and contracture development is often clinically evident as early as at 4 years of age. In addition to being thinner and weaker, skeletal muscle in children with CP develop poor quality, i.e., increasingly higher amounts of fat and connective tissue at the expense of functional, contractile proteins.
How long-term standard treatments for children with spastic CP including, training and orthotics use, with botulinum toxin (BoNT-A) treatment as an adjunct, affects muscle on functional, structural, and microscopic level in CP has not yet been published. Therefore, we will investigate the muscle function as well as functional mobility, structure, and spasticity. We will conduct functional mobility tests. Muscle strength will be measured with a rig-fixed dynamometer, and muscle structure will be measured with magnetic resonance imaging. The spasticity will be instrumentally assessed by the NeuroflexorTM, a machine measuring resistance in a muscle when a pedal is passively moving the participants foot at two different speeds. We will follow participants, for 1 year, with 4 measurements during this period.
In order to better treat these children, we need to better understand the complex, interrelated interactions of musculoskeletal properties and function in children with CP. Our hypothesis is that muscle structure and function is affected by standard clinical treatments sessions including routine botulinum toxin treatment. Analyzing the effect of standard care may help planning of more effective clinical treatments in the future.
Detailed description
How long-term standard treatments for children with spastic cerebral palsy (CP), including training and orthotics use, with botulinum toxin (BoNT-A) treatment as an adjunct, affects muscle on functional, structural, and microscopic level in CP has not yet been published. Therefore, we will investigate the muscle function as well as functional mobility, structure, and spasticity.
Research questions:
- How is muscle structure, muscle strength, spasticity and, stiffness of the calf muscle in CP related to motor function, and how does it differ to typically developing (TD) children?
- What is the long-term effect of a standard care with BoNT-A as an adjunct on motor function, muscle structure, muscle strength, spasticity, and stiffness?
Participants with spastic CP, aged between 5-17 years, are recruited from the Dept of Pediatric Orthopaedics, when clinically motivated plans for the first BoNT-A treatment session of the calf (plantar flexors) are set. Typically developing children at same ages are recruited through convenient sample and will take part of the assessments once. The children with CP will go through the following assessments at four different time-points; before, 3 months, 6 months, and one year after the first BoNT-A injection:
- Spasticity will be measured with clinical tests: Modified Tardieu scale and Modified Ashworth scale and with a instrumented device measuring muscle resistance, the NeuroflexorTM.
- Isometric strength measurements of plantar flexors and ankle dorsiflexors using a dynamometer (ChatillonTM) fixed in a custom-built testing frame while surface EMG is captured.
- Functional mobility in walking for example the Timed-Up-and-Go test (TUG-test) i.e. the time it takes for the child to stand up from a chair, walk 3 m, turn around, walk back, and sit down.
- Active and passive range of motion (ROM) measured with a goniometer
Before the first injection, the children with CP will be examined with magnetic resonance imaging (MRI) providing complex 3D structural information of individual muscles. One year after first injection, another examination with MRI will be conducted.
This explorative, observational, prospective, long time follow up study will be conducted at the Motion analysis laboratory at Astrid Lindgren's children's hospital and Huddinge Karolinska in collaboration with KTH Royal Institute of Technology.
Parametric and/or non-parametric statistical tests for within and between group comparisons, and correlations will be performed. Based on the pilot data from TD children the CP group and previous literature we need a sample size of 10-15 participants in each group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typically developing children | – | –Reference group of typically developing children |
| Cerebral palsy group | – | –Children with a diagnosis of cerebral palsy |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Participants with spastic CP are recruited from the Dept of Pediatric Orthopaedics, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden. The TD children are recruited from siblings of the participants with CP, and friends and family of the research group.
Key inclusion criteria (3 listed)
- Unilateral/Bilateral spastic CP without Botulinum toxin injection history
- Understanding study protocol and expressing voluntary consent of the family
- Dorsiflexion to at least a neutral position of the foot
Key exclusion criteria (2 listed)
- Contraindication to MRI scanning: metal fragments in the body, surgically implanted devices containing metal, severe claustrophobia, or inability to lie down in the MRI scanner, presence of pacemaker or other stimulators, shunts etc.
- Total range of ankle movement less than 35°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in muscle structure
Time frame: Before and one year after the first treatment session
MRI based examinations including muscle volume
Change in spasticity
Time frame: Before, three months, six months and 12 months after the firstt treatment session
Resistance at slow and fast passive movements of the foot
Change in muscle strength
Time frame: Before, three months, six months and 12 months after the first treatment session
Muscle strength measured as force with a dynamomter in the calf muscle
Change in functional mobility during walking
Time frame: Before, three months, six months and 12 months after the first treatment session
Time to complete a test of functional mobility during walking will be measured
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Derived from this study: PubMed 39394126Ahblom A, Ponten E, Destro A, Petersson S, von Walden F, Wang R, Lidbeck C. Exploration of the triceps surae muscle in ambulatory children with cerebral palsy using instrumented measurements of stiffness and diffusion tensor magnetic resonance imaging for muscle architecture. BMC Musculoskelet Disord. 2024 Oct 11;25(1):803. doi: 10.1186/s12891-024-07890-4.
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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.
R Wang, Ing, PhD principal investigator
KTH Royal Institute of Technology
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 and Musculoskeletal Deformity, run by Region Stockholm at 1 site in Sweden.
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 7 Jul 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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 muscle structure (time frame: Before and one year after the first treatment session). The study lists 4 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 NCT05447299, which also lists 1 linked publication.
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 7 Jul 2022.