Fatigability in SMA: validity and reproducibility of tests.

Fatigability in Spinal Muscular Atrophy: validity and reproducibility of tests.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29501

Enrollment

150

Registered

2014-04-01

Start date

2014-06-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

SMA Spinal Muscular Atrophy Fatigability

Interventions

Psychometric study on validity and reproducibility of fatigability tests

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subjects with SMA - Genetically confirmed diagnosis of SMA type 2 or type 3 or type 4 -Ability to follow test instructions -Parental informed consent/Inform consent -Age 8-50 years 2) Patient control group (matched on clinical status) -Genetically confirmed diagnosis of (neuro-) muscular disease, no signs of neuromuscular dysfunction -Ability to follow test instructions -Parental informed consent/ Informed consent -Age 8-50 years 3) Healthy control group (age and gender matched) -Sufficient understanding of Dutch -Ability to follow test instructions -Parental informed consent/ Informed consent -Age 8-50 years

Exclusion criteria

Exclusion criteria: All subjects: Concomitant medical problems that might intervene with the outcomes of the testing

Design outcomes

Primary

Measure	Time frame
1) Reproducibility of fatigability tests (reliability (ICC) , measurement error (ME) 2) Construct Validity - content validity between fatigability tests,perceived fatigue and peripheral muscle fatigue: Pearson/Spearman Correlation Coefficient - convergent validity between fatigability tests (endurance time and delta muscle strength values) and nerve conduction study (delta compound muscle action potential) : Pearson/Spearman Correlation Coefficient - convergent validity between fatigability tests (endurance time and delta muscle strength values), perceived fatigue (Borg scores and fatigue questionnaires) and peripheral muscle fatigue (EMG registration; Root Mean Square amplitude muscles arms/legs/respiratory) - discriminative validity between fatigability tests SMA patients, healthy control group and patient controle group: Analysis of Variance (ANOVA)	—

Measure

Time frame

1) Reproducibility of fatigability tests (reliability (ICC) , measurement error (ME) 2) Construct Validity - content validity between fatigability tests,perceived fatigue and peripheral muscle fatigue: Pearson/Spearman Correlation Coefficient - convergent validity between fatigability tests (endurance time and delta muscle strength values) and nerve conduction study (delta compound muscle action potential) : Pearson/Spearman Correlation Coefficient - convergent validity between fatigability tests (endurance time and delta muscle strength values), perceived fatigue (Borg scores and fatigue questionnaires) and peripheral muscle fatigue (EMG registration; Root Mean Square amplitude muscles arms/legs/respiratory) - discriminative validity between fatigability tests SMA patients, healthy control group and patient controle group: Analysis of Variance (ANOVA)

—

Secondary

Measure	Time frame
Feasibility parameters - measurement completion - acceptability - perceived burden	—

Contacts

Public ContactB. Bartels

Kinderbewegingscentrum | Wilhelmina Kinderziekenhuis | Universitair Medisch Centrum Utrecht Lundlaan 6, 3508 AB Utrecht

b.bartels-4@umcutrecht.nl+31 (0)88 75 54030

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)