Psychometrics of Two Translated Measurement ToolsNCT02237222
Evaluation of Gait Performance in Children With Neuromuscular Diagnoses
An observational study of Psychometrics of Two Translated Measurement Tools, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Psychometrics of Two Translated Measurement Tools
- What is being tested?
- Gait rehabilitation
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to 31 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with neuromuscular diagnoses, who are inpatients in the rehabilitation center of the University Children's Hospital Zurich in Affoltern am Albis.
Who may be able to join
- Neuromuscular diagnosis
- Age: 6-18 years
- Rehabilitation goal = improvement of walking abilities
Who cannot join
- Children's whose parents are not German-speaking
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich, Rehabilitation Center
Affoltern am Albis, CH-8910
About this study
Official title: 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.
Read the 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.
- Being tested
- Gait rehabilitation
- Keywords
- Outcome Assessment, Gait, Neuromuscular Diseases, Psychometrics, Clinical Assessment Tools
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gait rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Mobility Scale (FMS)
The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.
Measured: 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.
Measured: 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)
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.
Measured: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startApr 2014
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychometrics of Two Translated Measurement ToolsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Ammann-Reiffer, MPTSc, Principal investigator, University Children's Hospital Zurich, Rehabilitation Center Affoltern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237222
- Sponsor's protocol ID
- GaitPerformance_2014
- Status last verified
- Nov 2020
- First submitted
- 1 Sep 2014
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Gait Performance Measures 'Functional Mobility Scale' and 'Gillette Functional Assessment Questionnaire' in Children With Neuromuscular Diagnoses
- ClinicalTrials.gov ID
- NCT02237222
- Acronym / sponsor ID
- GaitPerformance_2014
- Keywords
- Outcome Assessment, Gait, Neuromuscular Diseases, Psychometrics, Clinical Assessment Tools
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait rehabilitation | – | Other: Gait rehabilitationMulti-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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with neuromuscular diagnoses, who are inpatients in the rehabilitation center of the University Children's Hospital Zurich in Affoltern am Albis.
Key inclusion criteria (3 listed)
- Neuromuscular diagnosis
- Age: 6-18 years
- Rehabilitation goal = improvement of walking abilities
Key exclusion criteria (1 listed)
- Children's whose parents are not German-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait rehabilitation | Other | Gait rehabilitation |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Research projects at the rehabilitation centre Affoltern am Albis, University Children's Hospital ZurichLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Ammann-Reiffer, MPTSc principal investigator
University Children's Hospital Zurich, Rehabilitation Center Affoltern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychometrics of Two Translated Measurement Tools, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.