- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02237222
Evaluation of Gait Performance in Children With Neuromuscular Diagnoses
November 4, 2020 updated by: University Children's Hospital, Zurich
Evaluation of the Gait Performance Measures 'Functional Mobility Scale' and 'Gillette Functional Assessment Questionnaire' 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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Affoltern am Albis, Switzerland, CH-8910
- University Children's Hospital Zurich, Rehabilitation Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with neuromuscular diagnoses, who are inpatients in the rehabilitation center of the University Children's Hospital Zurich in Affoltern am Albis.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gait rehabilitation
Multi-modal therapy program including physiotherapy with the aim of gait improvement, Lokomat or treadmill training, strength training, sports therapy. Frequency and intensity are individually assigned. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
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.
|
Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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The WeeFIM-Item Locomotion (Walking) is scored by the primary nurse.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
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.
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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.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
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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.
|
Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Corinne Ammann-Reiffer, MPTSc, University Children's Hospital Zurich, Rehabilitation Center Affoltern
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
January 31, 2016
Study Completion (Actual)
January 31, 2016
Study Registration Dates
First Submitted
September 1, 2014
First Submitted That Met QC Criteria
September 8, 2014
First Posted (Estimate)
September 11, 2014
Study Record Updates
Last Update Posted (Actual)
November 5, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- GaitPerformance_2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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