Fatigability in SMA: validity and reproducibility of tests.
- Conditions
- SMASpinal Muscular AtrophyFatigability
- Registration Number
- NL-OMON29501
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1) Subjects with SMA
- Genetically confirmed diagnosis of SMA type 2 or type 3 or type 4
Exclusion Criteria
All subjects:
Concomitant medical problems that might intervene with the outcomes of the testing
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Reproducibility of fatigability tests (reliability (ICC) , measurement error (ME)<br /><br>2) Construct Validity <br /><br>- content validity between fatigability tests,perceived fatigue and peripheral muscle fatigue: Pearson/Spearman Correlation Coefficient <br /> <br>- 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 <br /><br>- 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)<br /><br>- discriminative validity between fatigability tests SMA patients, healthy control group and patient controle group: Analysis of Variance (ANOVA)<br>
- Secondary Outcome Measures
Name Time Method Feasibility parameters<br /><br>- measurement completion<br /><br>- acceptability<br /><br>- perceived burden