NCT02237222

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

September 1, 2014

Last Update Submit

November 4, 2020

Conditions

Keywords

Outcome AssessmentGaitNeuromuscular DiseasesPsychometricsClinical Assessment Tools

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (1)

  • Global Rating Scale (GRS)

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

Other Outcomes (3)

  • Functional Independence Measure for Children (WeeFIM)

    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)

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

  • 6-Minute walk test (6MinWT)

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

Study Arms (1)

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.

Other: Gait rehabilitation

Interventions

Gait rehabilitation

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Children's whose parents are not German-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zurich, Rehabilitation Center

Affoltern am Albis, CH-8910, Switzerland

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Corinne Ammann-Reiffer, MPTSc

    University Children's Hospital Zurich, Rehabilitation Center Affoltern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 11, 2014

Study Start

April 1, 2014

Primary Completion

January 31, 2016

Study Completion

January 31, 2016

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations