Cerebral PalsyNCT02146989
Upper Extremity Strength in Cerebral Palsy
An observational study of Cerebral Palsy, run by Maastricht University Medical Center at 9 sites in Netherlands.
Trial summary
Rationale: Children with Cerebral Palsy (CP) experience limitations in motor activities and participation in the community, predominantly caused by impairments in muscle function. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- reproducibility of upper extremity strength measurements
- How many people
- 370 participants
- Where
- 9 sitesNetherlands
- Study dates
- Jun 2014to 19 Mar 2018
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Spastic unilateral Cerebral Palsy and Healthy Controls
Who may be able to join
- Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents),
- aged 7 to 18 years,
- MACS levels I-III,
- mentally able to perform the measurements
- children attending primary or secondary school
- agd 7 to 18 years
Who cannot join
- Surgical intervention <6 months
- Botulinum Toxin A treatment in the upper extremity < 6 months
- contractures in the upper extremity that might interfere with task performance
- muscle disease
- lesion, fracture or cast < 6 months
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Tolbrug
's-Hertogenbosch, 5200 ME
Klimmendaal
Arnhem, 6813 GC
Revant
Breda, 4817 JW
Libra Zorggroep
Eindhoven, 5602 BJ
Adelante
Hoensbroek, Limburg, 6432CC
Rijnlands Revalidatie Centrum
Leiden, 2333 AL
St. Maartenskliniek
Nijmegen, 6574 NA
Sophie Revalidatie
The Hague, 2543 SW
Viecuri Medical Centre
Venlo, 5912 BL
About this study
Official title: Upper Extremity Strength in Children and Adolescents With and Without Unilateral Cerebral Palsy
Rationale:
Children with Cerebral Palsy (CP) experience limitations in motor activities and participation in the community, predominantly caused by impairments in muscle function. Aside from abnormal posturing due to spasticity, muscle weakness can significantly contribute to impaired muscle function and there is increasing evidence that muscle weakness significantly impairs upper limb motor function and ability to perform manual tasks in children with CP. Studies in the last decade have shown that muscle weakness, not spasticity, is the greatest limiting factor of motor function in children with CP. Furthermore, there is increasing evidence that the strength in the upper extremities of children with CP is less compared to their typically developing peers (TDP). A systematic review focused on the psychometric properties of strength measurement instruments has shown that the number of studies investigating psychometric properties of strength measurement instruments is limited and that the methodological quality of these studies is low.
Read more
Aim:
The present study aims to investigate the reproducibility of the following three isometric strength measurements in the upper extremity of children and adolescents with unilateral CP as well as in TDP: Hand Held Dynamometry (HHD), pinch and grip strength using the E-link system and functional strength. To study to which extent upper extremity strength, both in the affected side and the non-affected side, differs from the strength in the upper extremities of TDP, these measurements will also be performed by children without neurological problems.
Study Design:
A cross-sectional study in which the reproducibility of three strength measurement instruments, i.e. HHD, E-link and Functional strength, will be investigated in children and adolescents with unilateral CP and TDP.
Population:
Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents), aged 7 to 18 years, Manual Ability Classification System (MACS) levels I-III, who are mentally able to perform the measurements will be included and TDP.
Outcome measures:
The most important psychometric property in strength measurement instruments is reproducibility. Reproducibility will be investigated using the following factors: Intraclass Correlation Coefficient (ICC), Limits of Agreement (LOA), Standard Error of Measurement (SEM) and the Smallest Detectable Difference (SDD). Reference values will be determined using the Generalised Additive Models for Location, Scale, and Shape (GAMLSS) method.
- Conditions
- Cerebral Palsy
- Being tested
- reproducibility of upper extremity strength measurements
- Keywords
- Cerebral Palsy, child, upper extremity, strength, reproducibility
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reproducibility of upper extremity strength measurementsOther
Also called Hand Held Dynamometry, E-link system, functional strength measurements
inter-rater reliability and test-retest reliability
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy | Children and adolescents with spastic unilateral Cerebral Palsy (with perinatal acquired hypoxic ischemic incidents), aged 7 to 18 years, MACS levels I-III. Receives: Other: reproducibility of upper extremity strength measurements | |
| Healthy controls | Children and adolescents without Cerebral Palsy Receives: Other: reproducibility of upper extremity strength measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater and test-retest reliability of HHD expressed as ICC value
The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.
Measured: t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest reliability of E-link expressed as ICC value
The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.
Measured: t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest reliability of functional strength measurements expressed as ICC value
The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.
Measured: t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest agreement of HHD expressed as Limits of Agreement
The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.
Measured: t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest agreement of E-Link expressed as Limits of Agreement
The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.
Measured: t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest agreement of functional measurements expressed as Limits of Agreement
The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.
Measured: t1 (base-line) and t1 (2-3 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJun 2014
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Adelante, Centre of Expertise in Rehabilitation and Audiology, Revant, Tolbrug, Libra Zorggroep, VieCuri Medical Centre
- Responsible party
- Sponsor
- Investigators
- Yvonne JM Janssen-Potten, PhD, Principal investigator, Adelante, Centre of Expertise in Rehabilitation and Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146989
- Sponsor's protocol ID
- NL45430.068.13
- Status last verified
- Apr 2018
- First submitted
- 21 May 2014
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Strength in Children and Adolescents With and Without Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02146989
- Acronym / sponsor ID
- NL45430.068.13
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, child, upper extremity, strength, reproducibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University, Adelante, Centre of Expertise in Rehabilitation and Audiology, Revant, Tolbrug, Libra Zorggroep, VieCuri Medical Centre
- Study start
- Jun 2014 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 26 May 2014 (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.
Rationale:
Children with Cerebral Palsy (CP) experience limitations in motor activities and participation in the community, predominantly caused by impairments in muscle function. Aside from abnormal posturing due to spasticity, muscle weakness can significantly contribute to impaired muscle function and there is increasing evidence that muscle weakness significantly impairs upper limb motor function and ability to perform manual tasks in children with CP. Studies in the last decade have shown that muscle weakness, not spasticity, is the greatest limiting factor of motor function in children with CP. Furthermore, there is increasing evidence that the strength in the upper extremities of children with CP is less compared to their typically developing peers (TDP). A systematic review focused on the psychometric properties of strength measurement instruments has shown that the number of studies investigating psychometric properties of strength measurement instruments is limited and that the methodological quality of these studies is low.
Aim:
The present study aims to investigate the reproducibility of the following three isometric strength measurements in the upper extremity of children and adolescents with unilateral CP as well as in TDP: Hand Held Dynamometry (HHD), pinch and grip strength using the E-link system and functional strength. To study to which extent upper extremity strength, both in the affected side and the non-affected side, differs from the strength in the upper extremities of TDP, these measurements will also be performed by children without neurological problems.
Study Design:
A cross-sectional study in which the reproducibility of three strength measurement instruments, i.e. HHD, E-link and Functional strength, will be investigated in children and adolescents with unilateral CP and TDP.
Population:
Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents), aged 7 to 18 years, Manual Ability Classification System (MACS) levels I-III, who are mentally able to perform the measurements will be included and TDP.
Outcome measures:
The most important psychometric property in strength measurement instruments is reproducibility. Reproducibility will be investigated using the following factors: Intraclass Correlation Coefficient (ICC), Limits of Agreement (LOA), Standard Error of Measurement (SEM) and the Smallest Detectable Difference (SDD). Reference values will be determined using the Generalised Additive Models for Location, Scale, and Shape (GAMLSS) method.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy | – | Other: reproducibility of upper extremity strength measurementsChildren and adolescents with spastic unilateral Cerebral Palsy (with perinatal acquired hypoxic ischemic incidents), aged 7 to 18 years, MACS levels I-III. |
| Healthy controls | – | Other: reproducibility of upper extremity strength measurementsChildren and adolescents without Cerebral Palsy |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Spastic unilateral Cerebral Palsy and Healthy Controls
Key inclusion criteria (6 listed)
- Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents),
- aged 7 to 18 years,
- MACS levels I-III,
- mentally able to perform the measurements
- children attending primary or secondary school
Key exclusion criteria (5 listed)
- Surgical intervention <6 months
- Botulinum Toxin A treatment in the upper extremity < 6 months
- contractures in the upper extremity that might interfere with task performance
- muscle disease
- lesion, fracture or cast < 6 months
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 |
|---|---|---|
| reproducibility of upper extremity strength measurementsAlso: Hand Held Dynamometry, E-link system, functional strength measurementsinter-rater reliability and test-retest reliability | Other | Cerebral Palsy, Healthy controls |
Primary outcome
Inter-rater and test-retest reliability of HHD expressed as ICC value
Time frame: t1 (base-line) and t1 (2-3 weeks later)
The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.
Inter-rater and test-retest reliability of E-link expressed as ICC value
Time frame: t1 (base-line) and t1 (2-3 weeks later)
The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.
Inter-rater and test-retest reliability of functional strength measurements expressed as ICC value
Time frame: t1 (base-line) and t1 (2-3 weeks later)
The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.
Inter-rater and test-retest agreement of HHD expressed as Limits of Agreement
Time frame: t1 (base-line) and t1 (2-3 weeks later)
The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.
Inter-rater and test-retest agreement of E-Link expressed as Limits of Agreement
Time frame: t1 (base-line) and t1 (2-3 weeks later)
The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.
Inter-rater and test-retest agreement of functional measurements expressed as Limits of Agreement
Time frame: t1 (base-line) and t1 (2-3 weeks later)
The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.
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 26 Apr 2018.
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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.
Yvonne JM Janssen-Potten, PhD principal investigator
Adelante, Centre of Expertise in Rehabilitation and Audiology
9 sites 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 Maastricht University Medical Center at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 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 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater and test-retest reliability of HHD expressed as ICC value (time frame: t1 (base-line) and t1 (2-3 weeks later)). The study lists 6 primary outcomes in all. 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 26 Apr 2018.