Optimization of the International Paediatric Mitochondrial Disease Scale

Optimization of the International Paediatric Mitochondrial Disease Scale - IPMDS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43155

Enrollment

195

Registered

2017-01-25

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

energy metabolism disturbances

Interventions

children

Mitochondrial disease

Outcome measures

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Study i) Healthy children aged 0-18 years. - Study ii) Children with a mitochondrial disease admitted for the MItoRoute - Study iii) Children with a mitochondrial encephalopathy with abnormalities at the neurological examination, admitted for the MItoRoute

Exclusion criteria

Exclusion criteria: - Study i) Having a known health condition - Study ii) and iii) The study is estimated to be too burdensome to the patient

Design outcomes

Primary

Measure	Time frame
International Paediatric Mitochondrial Disease Score (IPMDS) The newly developed International Paediatric Mitochondrial Disease Score (IPMDS) was designed to follow children with a mitochondrial disease in e.g. clinical trials and detailed natural history studies. It consist of the following subdomains: 1. Complaints and symptoms; 2. Physical examination and 3. Functional tests. Its reliability and validity are to be tested in this study. The scale takes about 35 minutes to perform, of which 25 for Domain 1 and 10 for Domain 2 and 3 each. The patient should be involved in the assessment of Domain 2 and 3 but not necessarily for Domain 1.	—

Measure

Time frame

International Paediatric Mitochondrial Disease Score (IPMDS) The newly developed International Paediatric Mitochondrial Disease Score (IPMDS) was designed to follow children with a mitochondrial disease in e.g. clinical trials and detailed natural history studies. It consist of the following subdomains: 1. Complaints and symptoms; 2. Physical examination and 3. Functional tests. Its reliability and validity are to be tested in this study. The scale takes about 35 minutes to perform, of which 25 for Domain 1 and 10 for Domain 2 and 3 each. The patient should be involved in the assessment of Domain 2 and 3 but not necessarily for Domain 1.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)