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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02237222
Other study ID # GaitPerformance_2014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date January 31, 2016

Study information

Verified date November 2020
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date January 31, 2016
Est. primary completion date January 31, 2016
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Neuromuscular diagnosis - Age: 6-18 years - Rehabilitation goal = improvement of walking abilities Exclusion Criteria: - Children's whose parents are not German-speaking

Study Design


Related Conditions & MeSH terms

  • Psychometrics of Two Translated Measurement Tools

Intervention

Other:
Gait rehabilitation


Locations

Country Name City State
Switzerland University Children's Hospital Zurich, Rehabilitation Center Affoltern am Albis

Sponsors (1)

Lead Sponsor Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Functional Independence Measure for Children (WeeFIM) The WeeFIM-Item Locomotion (Walking) is scored by the primary nurse. Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
Other 10-Meter Walk Test (10MWT) 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. Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
Other 6-Minute walk test (6MinWT) 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. Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
Primary Functional Mobility Scale (FMS) The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child. Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
Primary Gillette Functional Assessment Questionnaire - Walking Scale (GFAQ) The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child. Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
Secondary Global Rating Scale (GRS) 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. Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.