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NCT Number: NCT05564962

Quality and Independence of Gait Classification Scale for DMD (QIGS-DMD)

The aim of this study was to develop a reliable and valid gait classification scale for Duchenne Muscular Dystrophy (QIGS-DMD). The items of the QIGS-DMD were designed based on the literature review considering existing functional classification scales, gait scales, and the opinions of the physiotherapists who were expertized in rehabilitation of patients with DMD. Content validity was determined based on the opinions of a total of ten expert physiotherapists. Videos were recorded during gait of 69 children with DMD and inter- and intra-rater reliability were examined. Criterion validity was determined according to the relationship between QIGS-DMD and Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gait Disorders in Children Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

5 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Güllü Aydın Yağcıoğlu

Isparta, 32100, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being 5 years old or above, and
  • having a confirmed diagnosis of Duchenne Muscular Dystrophy.

Exclusion criteria

  • having other coexisting medical or psychiatric diseases or injury and/or surgery related to the lower extremities within the last 6 months

Treatment and study plan

Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)

Diagnostic Test

MFM is a valid and reliable measure to evaluate the severity of the motor deficit of both ambulatory and non-ambulatory children with neuromuscular diseases. MFM consists of 32 items in 3 dimensions and is scored as a percentage of the maximum possible score which higher scores indicate better functional status. VLERS is a 10-item ordinal scale that identifies the functional status of the lower limbs. According to VLERS, level 1 indicates that the patient can walk independently and climb stairs without assistance while level 10 indicates is the patient is bedridden.

Other names: Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).

Primary outcomes

  1. Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)

    Time frame: 10 minutes

    It is the scale developed within the scope of the study.

Secondary outcomes

  1. Motor Fucntion Measure (MFM)

    Time frame: 20-30 minutes

    MFM is a valid and reliable measure to evaluate the severity of the motor deficit of both ambulatory and non-ambulatory children with neuromuscular diseases. MFM consists of 32 items in 3 dimensions and is scored as a percentage of the maximum possible score which higher scores indicate better functional status.

  2. Vignos Lower Extremity Rating Scale (VLERS)

    Time frame: 10 minutes

    VLERS is a 10-item ordinal scale that identifies the functional status of the lower limbs. According to VLERS, level 1 indicates that the patient can walk independently and climb stairs without assistance while level 10 indicates is the patient is bedridden

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD): The Development, Validity and Reliability

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 4, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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