not yet recruiting

A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular Disorders

key information

study id #: NCT05109637

condition: Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis

status: Not yet recruiting


The primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments.

The secondary objectives of this study are to evaluate the test-retest reliability of smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship between Konectom upper limb DOAs and conventional upper limb assessments in clinical environments; to determine the relationship between Konectom lower limb DOAs and status of ambulation in clinical environments; to evaluate group differences in smartphone-based Konectom DOAs [self-administered at home and in-clinic] between person with spinal muscular atrophy (PwSMA) or person with amyotrophic lateral sclerosis (PwALS) and healthy subjects (HS); to evaluate the variability of Konectom DOAs self-administered in everyday environment in HS and PwSMA or PwALS; to compare Konectom DOAs between in-clinic supervised administration versus self-assessments in everyday environment in HS, PwSMA and PwALS groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes (PROs) in PwSMA or PwALS and to evaluate the clinical safety of Konectom in PwSMA and PwALS.

intervention: Konectom NMD Application


last updated: February 04, 2022