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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2023-07-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Muscular Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Participants with SMA (PwSMA)

Participants with SMA will have their motor functions assessed using the Konectom NMD smartphone-based application up to Day 28.

Group Type EXPERIMENTAL

Konectom NMD Application

Intervention Type DEVICE

Administered as specified in the treatment arm.

Participants with ALS (PwALS)

Participants with ALS will have their cognitive and motor functions assessed using the Konectom NMD smartphone-based application up to Day 28.

As per protocol version 4.0, enrolment of ALS participants is stopped, and the data of the already enrolled ALS participants would not be analyzed.

Group Type EXPERIMENTAL

Konectom NMD Application

Intervention Type DEVICE

Administered as specified in the treatment arm.

Healthy Participants

Healthy participants will have their cognitive and motor functions assessed using the Konectom NMD smartphone-based application for 28 days.

Group Type EXPERIMENTAL

Konectom NMD Application

Intervention Type DEVICE

Administered as specified in the treatment arm.

Interventions

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Konectom NMD Application

Administered as specified in the treatment arm.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

For PwSMA

* Genetic documentation of 5q SMA (homozygous gene deletion, mutation, or compound heterozygote).

For Healthy Participants

* Age group matched with SMA participants

Exclusion Criteria

For PwSMA

* Change of disease modifying treatment (DMT) in the last 1 month.
* Recent history of bacterial meningitis, viral encephalitis, or hydrocephalus.
* Addiction (alcohol or another drug abuse).
* Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or of an implanted central nervous system (CNS) catheter.
* Hospitalization for surgery (i.e., scoliosis surgery or other surgery), pulmonary event, or nutritional support in the previous 2 months or planned within the study duration.
* Known pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No