Muscle HypotoniaNCT05131542
Assessment of Hypotonia in Children With Down Syndrome
An observational study of Muscle Hypotonia and Down Syndrome, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome. Read more about this study
- Who is it for?
- Ages 7 months to 8 years
- Conditions the study is for
- Muscle Hypotonia, Down Syndrome, Muscle, Floppy
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 15 Jan 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 7 months to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Down Syndrome
Who may be able to join
- Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old
Who cannot join
- Other hypotonic syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Measuring Instrument for the Evaluation of Hypotonia in Children With Down Syndrome
Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome.
Read the detailed description
Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an instrument for early diagnosis, a systematic review was carried out which compiled characteristics and testing that are attributed to or used in the diagnosis of hypotonia. They were presented as an item group and a first stage was created and administered to 50 children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the results showed which characteristics were really related to the convention and which were more affected by changing factors. Then a final scale was developed that met the expected requirements of validity and reliability.
- Conditions
- Muscle Hypotonia, Down Syndrome, Muscle, Floppy, CHILD Syndrome, Infant Floppy
- Medical subject headings
- Muscle Hypotonia, Down Syndrome, Congenital Hemidysplasia with Ichthyosiform Erythroderma and Limb Defects
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 |
|---|---|---|
| Down Syndrome | Children with down syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.
A study of homogeneity of the items was carried out to know if each item was measuring the same as the globality of the test. It was carried out by means of a reliability study of the statistics of each item compared to the total scale.
Measured: 1 month
Analysis of the reliability of the scale
Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed
Measured: 1 month
Content validity
It was done through expert judgment. It was reviewed by three physiotherapists with extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Measured: 1 month
Empirical validity.
The correlation between the graduation of hypotonia derived from the scale and the observational diagnosis estimated by the evaluator was analyzed. An ANOVA test was used to compare both diagnostic assessments.extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Measured: 1 month
Structural validity
Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program.
Measured: In the process of analysis. 1 month to get results.
Secondary outcomes (3)
Descriptive analysis of the scale
Analyzing the values of standard deviation, mean, bias and kurtosis.
Measured: 1 month
Frequency analysis of the items.
Frequency with which 0 (less hypotonia), 1 or 2 (greater hypotonia) each item of the scale has been scored.
Measured: 1 month
Analysis of the scale items.
An analysis of standard deviation, mean, correlation and Cronbach's alpha was performed for each item that made up the scale.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Apr 2019
- Primary completion31 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Muscle HypotoniaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Guadalupe de Santos Moreno, Universidad de Murcia
- Investigators
- Mª Guadalupe de Santos Moreno, MSc PT, Principal investigator, Unicersity of MurciaAntonia Gómez Conesa, PhD PT, Study director, Unicersity of MurciaJosé Antonio López Pina, PhD, Study director, Unicersity of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131542
- Sponsor's protocol ID
- 1999/2018
- Status last verified
- Jan 2022
- First submitted
- 21 Oct 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Martin K, Inman J, Kirschner A, Deming K, Gumbel R, Voelker L. Characteristics of hypotonia in children: a consensus opinion of pediatric occupational and physical therapists. Pediatr Phys Ther. 2005 Winter;17(4):275-82. doi: 10.1097/01.pep.0000186506.48500.7c.
PubMed 16357683Govender P, Joubert RWE. 'Toning' up hypotonia assessment: A proposal and critique. Afr J Disabil. 2016 May 26;5(1):231. doi: 10.4102/ajod.v5i1.231. eCollection 2016.
PubMed 28730054Goo M, Tucker K, Johnston LM. Muscle tone assessments for children aged 0 to 12 years: a systematic review. Dev Med Child Neurol. 2018 Jul;60(7):660-671. doi: 10.1111/dmcn.13668. Epub 2018 Feb 6.
PubMed 29405265Martin K, Kaltenmark T, Lewallen A, Smith C, Yoshida A. Clinical characteristics of hypotonia: a survey of pediatric physical and occupational therapists. Pediatr Phys Ther. 2007 Fall;19(3):217-26. doi: 10.1097/PEP.0b013e3180f62bb0.
PubMed 17700351Govender P, Joubert RWE. Evidence-Based Clinical Algorithm for Hypotonia Assessment: To Pardon the Errs. Occup Ther Int. 2018 Apr 24;2018:8967572. doi: 10.1155/2018/8967572. eCollection 2018.
PubMed 29853815Naidoo P, Joubert RW. Consensus on hypotonia via Delphi process. Indian J Pediatr. 2013 Aug;80(8):641-50. doi: 10.1007/s12098-013-1018-7. Epub 2013 May 17.
PubMed 23681830Reus L, van Vlimmeren LA, Staal JB, Janssen AJ, Otten BJ, Pelzer BJ, Nijhuis-van der Sanden MW. Objective evaluation of muscle strength in infants with hypotonia and muscle weakness. Res Dev Disabil. 2013 Apr;34(4):1160-9. doi: 10.1016/j.ridd.2012.12.015. Epub 2013 Feb 1.
PubMed 23380578Naidoo P. Development of an evidence-based clinical algorithm for practice in hypotonia assessment: a proposal. JMIR Res Protoc. 2014 Dec 5;3(4):e71. doi: 10.2196/resprot.3581.
PubMed 25485571
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Measuring Instrument for the Evaluation of Hypotonia in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05131542
- Acronym / sponsor ID
- 1999/2018
- Conditions
- Muscle Hypotonia, Down Syndrome, Muscle, Floppy, CHILD Syndrome, Infant Floppy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 23 Nov 2021 (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.
Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome.
Detailed description
Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an instrument for early diagnosis, a systematic review was carried out which compiled characteristics and testing that are attributed to or used in the diagnosis of hypotonia. They were presented as an item group and a first stage was created and administered to 50 children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the results showed which characteristics were really related to the convention and which were more affected by changing factors. Then a final scale was developed that met the expected requirements of validity and reliability.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Down Syndrome | – | –Children with down syndrome |
Who may qualify
- Ages
- 7 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Down Syndrome
Key inclusion criteria (1 listed)
- Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old
Key exclusion criteria (1 listed)
- Other hypotonic syndromes
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
Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.
Time frame: 1 month
A study of homogeneity of the items was carried out to know if each item was measuring the same as the globality of the test. It was carried out by means of a reliability study of the statistics of each item compared to the total scale.
Analysis of the reliability of the scale
Time frame: 1 month
Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed
Content validity
Time frame: 1 month
It was done through expert judgment. It was reviewed by three physiotherapists with extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Empirical validity.
Time frame: 1 month
The correlation between the graduation of hypotonia derived from the scale and the observational diagnosis estimated by the evaluator was analyzed. An ANOVA test was used to compare both diagnostic assessments.extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Structural validity
Time frame: In the process of analysis. 1 month to get results.
Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program.
3 secondary outcomes
Descriptive analysis of the scale
Time frame: 1 month
Frequency analysis of the items.
Time frame: 1 month
Analysis of the scale items.
Time frame: 1 month
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 21 Jan 2022.
- Background: PubMed 16357683Martin K, Inman J, Kirschner A, Deming K, Gumbel R, Voelker L. Characteristics of hypotonia in children: a consensus opinion of pediatric occupational and physical therapists. Pediatr Phys Ther. 2005 Winter;17(4):275-82. doi: 10.1097/01.pep.0000186506.48500.7c.
- Background: PubMed 28730054Govender P, Joubert RWE. 'Toning' up hypotonia assessment: A proposal and critique. Afr J Disabil. 2016 May 26;5(1):231. doi: 10.4102/ajod.v5i1.231. eCollection 2016.
- Background: PubMed 29405265Goo M, Tucker K, Johnston LM. Muscle tone assessments for children aged 0 to 12 years: a systematic review. Dev Med Child Neurol. 2018 Jul;60(7):660-671. doi: 10.1111/dmcn.13668. Epub 2018 Feb 6.
- Background: PubMed 17700351Martin K, Kaltenmark T, Lewallen A, Smith C, Yoshida A. Clinical characteristics of hypotonia: a survey of pediatric physical and occupational therapists. Pediatr Phys Ther. 2007 Fall;19(3):217-26. doi: 10.1097/PEP.0b013e3180f62bb0.
- Background: PubMed 29853815Govender P, Joubert RWE. Evidence-Based Clinical Algorithm for Hypotonia Assessment: To Pardon the Errs. Occup Ther Int. 2018 Apr 24;2018:8967572. doi: 10.1155/2018/8967572. eCollection 2018.
- Background: PubMed 23681830Naidoo P, Joubert RW. Consensus on hypotonia via Delphi process. Indian J Pediatr. 2013 Aug;80(8):641-50. doi: 10.1007/s12098-013-1018-7. Epub 2013 May 17.
- Background: PubMed 23380578Reus L, van Vlimmeren LA, Staal JB, Janssen AJ, Otten BJ, Pelzer BJ, Nijhuis-van der Sanden MW. Objective evaluation of muscle strength in infants with hypotonia and muscle weakness. Res Dev Disabil. 2013 Apr;34(4):1160-9. doi: 10.1016/j.ridd.2012.12.015. Epub 2013 Feb 1.
- Background: PubMed 25485571Naidoo P. Development of an evidence-based clinical algorithm for practice in hypotonia assessment: a proposal. JMIR Res Protoc. 2014 Dec 5;3(4):e71. doi: 10.2196/resprot.3581.
- The American Academy for Cerebral Palsy and Developmental Medicine, develops a care pathway for therapeutic interventions for central hypotoniaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Muscle Hypotonia
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Recruiting
Small Doses Muscle Relaxant in General Anesthesia
Muscle Relaxant
Enrolling by invitationPhase 3
Efficacy and Safety of HRS-9190 in General Anesthesia
Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective Surgery
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.
Mª Guadalupe de Santos Moreno, MSc PT principal investigator
Unicersity of Murcia
Antonia Gómez Conesa, PhD PT study director
Unicersity of Murcia
José Antonio López Pina, PhD study director
Unicersity of Murcia
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 Muscle Hypotonia and Down Syndrome, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 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 Spain. 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?
Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program. (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131542, which also lists 8 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 21 Jan 2022.