NCT05109637

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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) and healthy subjects (HS); to evaluate the variability of Konectom DOAs self-administered in everyday environment in HS and PwSMA; to compare Konectom DOAs between in-clinic supervised administration versus self-assessments in everyday environment in HS, PwSMA groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes (PROs) in PwSMA and to evaluate the clinical safety of Konectom in PwSMA.

Conditions

• Spinal Muscular Atrophy

Interventions

Type	Name	Description
DEVICE	Konectom NMD Application	Administered as specified in the treatment arm.

Timeline

• Start date: 2022-02-10
• Primary completion: 2023-07-10
• Completion: 2023-07-25
• First posted: 2021-11-05
• Last updated: 2024-02-06

Locations

5 sites across 1 country: Germany