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Completed

NCT Number: NCT02237222

Evaluation of Gait Performance in Children With Neuromuscular Diagnoses

The aims of this project are to evaluate the psychometric properties of the German versions of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years with a neuromuscular diagnosis.

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Key information

Conditions

Psychometrics of Two Translated Measurement Tools Nervous System Diseases Neuromuscular Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurich, Rehabilitation Center

Affoltern am Albis, CH-8910, Switzerland

About this study

The German versions of the two questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette Functional Assessment Questionnaire - walking scale' (GFAQ) are evaluated in terms of construct validity, inter- and intra-rater reliability as well as responsiveness in children with a neuromuscular diagnosis, who absolve an inpatient stay in the rehabilitation center of the University Chilren's Hospital Zurich, Switzerland.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Neuromuscular diagnosis
  • Age: 6-18 years
  • Rehabilitation goal = improvement of walking abilities

Exclusion criteria

  • Children's whose parents are not German-speaking

Treatment and study plan

Gait rehabilitation

Other

Primary outcomes

  1. Functional Mobility Scale (FMS)

    Time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.

    The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.

  2. Gillette Functional Assessment Questionnaire - Walking Scale (GFAQ)

    Time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.

    The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.

Secondary outcomes

  1. Global Rating Scale (GRS)

    Time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.

    A global rating on the perceived change of the child's functional mobility over the rehabilitation period and whether this change is perceived as meaningful or not; on a 5-point Likert scale, scored by the parents and the physiotherapist.

Other outcomes

  1. Functional Independence Measure for Children (WeeFIM)

    Time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.

    The WeeFIM-Item Locomotion (Walking) is scored by the primary nurse.

  2. 10-Meter Walk Test (10MWT)

    Time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.

    For the evaluation of the construct validity of the FMS and the GFAQ, the 10MWT comfortable speed as well as maximal speed will be performed shortly before discharge on a 14-meter long track with standardized instructions.

  3. 6-Minute walk test (6MinWT)

    Time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.

    For the evaluation of the construct validity of the FMS and the GFAQ, the 6MinWT is performed shortly before discharge on a 30-meter long track with standardized instructions.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Evaluation of the Gait Performance Measures 'Functional Mobility Scale' and 'Gillette Functional Assessment Questionnaire' in Children With Neuromuscular Diagnoses

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2014
Registry last updated
Nov 5, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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