Symptoms and Outcome Measures for Upper- Limb Function in Myotonic Dystrophy Type 1

NCT ID: NCT05006924

Last Updated: 2025-04-27

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

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-10

Study Completion Date

2024-08-31

Brief Summary

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Myotonic Dystrophy type 1 (DM1) is a multisystem disease that causes muscle weakness and myotonia. As a result upper limb function might become impaired. In this study we will examine patients with DM1 and record their upper limb function. We will will use a battery of patient reported outcomes (PROs) and Outcome measures (OMs) in order to evalute which ones are suitable for use in clinical practise and research studies.

Detailed Description

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Conditions

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Myotonic Dystrophy 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

• Genetically confirmed Myotonic Dystrophy type 1

Exclusion Criteria

* Unable to answer or understand questionnaires due to language barriers or cognitive status
* Unable to perform functional tests
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristin Ørstavik

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin L Ørstavik, PHD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Hilde S Robinson, PHD

Role: STUDY_DIRECTOR

University of Oslo

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Oslo University Hispital

Oslo, , Norway

Site Status

Frambu Centre for Rare Disorders

Siggerud, , Norway

Site Status

Countries

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Norway

Other Identifiers

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255164

Identifier Type: -

Identifier Source: org_study_id

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