ChildrenNCT03818152
Reliability and Validity of Strength Measurements of the Lower Limbs in Children With Bilateral Spastic Cerebral Palsy.
A study testing Functional strength assessment in people with Children and Cerebral Palsy, run by University Ghent at 1 site in Belgium.
Trial summary
Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence on muscle strength and consequently on functional behavior and participation. Evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Children, Cerebral Palsy, Muscle Weakness
- What is being tested?
- Functional strength assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Nov 2018to 15 Feb 2019
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Bilateral spastic CP
- GMFCS II-III
- 6-18 Y
- No botox until 4 months before testing
- No orthopedic surgery until 1 Y before testing
- Good cooperation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence on muscle strength and consequently on functional behavior and participation. Evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. Lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type).
The use of functional strength exercises to assess and train strength of the lower limbs in children with CP is well implemented in the most functional children with CP (GMFCS-level I). To assess isometric strength the hand held dynamometer (HHD) can be used in clinical settings but reliability of this tool is questionable.
The aim of this study is to adapt existing functional strength tests for less functional children with CP (focussing on GMFCS level II and III) and to investigate the correlation with isometric strength measurements and other functional parameters.
Read the detailed description
Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence on muscle strength and consequently on functional behavior and participation. Evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. Lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type).
The use of functional strength exercises to assess and train strength of the lower limbs in children with CP is well implemented in the most functional children with CP (GMFCS-level I).
The aim of this study is to adapt existing functional strength tests for less functional children with CP (focussing on GMFCS-level II and III) and to investigate the correlation with isometric strength measurements and other functional parameters.
- Conditions
- Children, Cerebral Palsy, Muscle Weakness
- Being tested
- Functional strength assessment
- Keywords
- Cerebral palsy, Children, Functional strength measurement, Lower limbs, Reproducability
- Medical subject headings
- Cerebral Palsy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional strength assessmentOther
Functional strength exercises to assess strength in lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | Reliability study isokinetic strength assessment of the lower limbs. Receives: Other: Functional strength assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional testing
30 seconds tests (nr/30 seconds): the children have to perform as much as trials as possible within 30 seconds; e.g. stand up and sit
Measured: 60 minutes
Secondary outcomes (4)
Isometric strength test
Strength of the lower limbs (Nm) by means of a fixed hand held dynamometer
Measured: 60 minutes
Core stability test
30 seconds tests (nr/3 30 seconds test (nr/30 seconds)
Measured: 30 minutes
Gait capacity
1 Minute Walking Test (m/1 minute)
Measured: 1 minute
Gait capacity
Timed up and go (seconds)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start30 Nov 2018
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by University GhentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818152
- Sponsor's protocol ID
- B670201834766/Amendement
- Status last verified
- Dec 2023
- First submitted
- 25 Jan 2019
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Strength Measurements of the Lower Limbs in Children With Bilateral Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT03818152
- Acronym / sponsor ID
- B670201834766/Amendement
- Conditions
- Children, Cerebral Palsy, Muscle Weakness
- Keywords
- Cerebral palsy, Children, Functional strength measurement, Lower limbs, Reproducability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 28 Jan 2019 (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.
Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence on muscle strength and consequently on functional behavior and participation. Evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. Lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type).
The use of functional strength exercises to assess and train strength of the lower limbs in children with CP is well implemented in the most functional children with CP (GMFCS-level I). To assess isometric strength the hand held dynamometer (HHD) can be used in clinical settings but reliability of this tool is questionable.
The aim of this study is to adapt existing functional strength tests for less functional children with CP (focussing on GMFCS level II and III) and to investigate the correlation with isometric strength measurements and other functional parameters.
Detailed description
Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence on muscle strength and consequently on functional behavior and participation. Evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. Lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type).
The use of functional strength exercises to assess and train strength of the lower limbs in children with CP is well implemented in the most functional children with CP (GMFCS-level I).
The aim of this study is to adapt existing functional strength tests for less functional children with CP (focussing on GMFCS-level II and III) and to investigate the correlation with isometric strength measurements and other functional parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Other: Functional strength assessmentReliability study isokinetic strength assessment of the lower limbs. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Bilateral spastic CP
- GMFCS II-III
- 6-18 Y
- No botox until 4 months before testing
- No orthopedic surgery until 1 Y before testing
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Functional strength assessmentFunctional strength exercises to assess strength in lower limbs. | Other | study group |
Primary outcome
Functional testing
Time frame: 60 minutes
30 seconds tests (nr/30 seconds): the children have to perform as much as trials as possible within 30 seconds; e.g. stand up and sit
4 secondary outcomes
Isometric strength test
Time frame: 60 minutes
Core stability test
Time frame: 30 minutes
Gait capacity
Time frame: 1 minute
Gait capacity
Time frame: 5 minutes
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 13 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional strength assessment in people with Children and Cerebral Palsy, run by University Ghent at 1 site in Belgium.
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 0 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 13 Dec 2023. 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 Belgium. 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?
Functional testing (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2023.