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Trial record 28 of 52199 for:    questionnaire

Responsiveness and Minimal Clinical Important Difference of the Multiple Sclerosis Questionnaire for Physiotherapists

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ClinicalTrials.gov Identifier: NCT02346279
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 27, 2015
Sponsor:
Collaborators:
Schweizer Physiotherapie Verband physioswiss
Schweizerische Multiple Sklerose Gesellschaft
Information provided by (Responsible Party):
Institut fuer Physiotherapieforschung

Brief Summary:
The aim of this survey is the evaluation of the responsiveness and the estimation of the MCID of the German and French Multiple Sclerosis Questionnaire for Physiotherapists, a self-rating Patient Reported Outcome questionnaire. This multicenter project uses a combined anchor and distribution based approach with multiple anchors to provide a range of MCID estimates or a single MCID for the reliable and valid Items, Activity and Participation group and the Total Score of the MSQPT, which should to be used as guidelines in daily practice.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Questionnaires, EDSS, physical test

Detailed Description:

The MSQPT is a highly reliable and valid questionnaire that was designed to be an aid for physiotherapists to asses the course of treatment of Persons with MS (PwMS). The assessment of the responsiveness of the MSQPT, which is so crucial for the evaluative value of an instrument used in long time treatment of PwMS, is the focus of this study.

This multicenter study uses a convenience sample of 81 PwMS, who are in short or long term treatment widespread over Switzerland. At baseline, the testers record age, gender, type of MS and disease duration since diagnosis. The tests will be executed in the following order: six-meter Timed Walking Test (6MTWT), nine-hole peg test (9HPT), Berg Balance Scale (BBS), MSQPT, Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS), Expanded Disability Status Scale (EDSS) and Transition Questionnaires for the Patient and the treating physiotherapist. Finally the six-minute walk (6MWT) rest will be carried out. The intervention with long term patients was planned every next 6 months after the baseline testing (T1, T2 and T3). The short time patient will be tested at base line and after 3 to 4 months or at the end of the rehabilitation period (T1).

A standardized test protocol manual will be used by the experienced and trained testers.

Effect Size , Standardized Response Mean (SRM). Modified SRM (MSRM), Relative Efficiency (RE), Sensitivity and Specificity and correlation estimates will describe the anchor based responsiveness. The combined anchor and distribution based approach is used in search of a MCID. The distribution based approach uses statistics like Standard Deviation, Standard Error of Measurement and Minimal Detectable Change as indicators of MCID. The anchor based approach uses global ratings of change out of the perspective of the patient and the physiotherapist for different aspects of health: general health status, balance, walking ability, arm function, fatigue, pain, amount of being active, participation in social life and general impairment due to MS. Minimal change is defined as one to two gradient change on the 9 point scale of the transition questions. The expected wide range of MCIDs will be narrowed to a small range or single MCID by triangulation and selection of the MCID with best selectivity and specificity.


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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Evaluate the Responsiveness and Minimal Clinical Important Difference (MCID) of the 'Multiple Sclerosis Questionnaire for Physiotherapists' (MSQPT)
Study Start Date : April 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Persons in physical therapy treatment
Questionnaires (MSQPT, HAQUAMS, Transition Questionnaire for Patient and treating physiotherapist), physical tests (9HPT, 6MTWT, BBS, 6MWT), EDSS
Other: Questionnaires, EDSS, physical test
6 Meter timed walking test, Nine Hole Peg Test, Berg balance Scale, MSQPT, HAQUAMS, Transition Questionnaire for Patients, Transition Questionnaire for Therapists, EDSS, 6 Minute Walking Test




Primary Outcome Measures :
  1. Multiple Sclerosis Questionnaire for Physical Therapists [ Time Frame: 20 minutes ]
    Items 'Taking a Shower', 'Getting in and out of a car', 'Walking distance' and Walking Time', Activity Group, Participation Group, Total Sum of Items


Secondary Outcome Measures :
  1. 6 Meter Timed Walking Test [ Time Frame: 3 to 20 seconds ]
    Walking 6 Meter, static start, walking at normal speed with or without an walking aid, average of three repetitions

  2. Nine Hole Peg Test [ Time Frame: up to 5 minutes ]
    Putting as fast as possible nine pegs, one after the other, in nine holes and put them back, one after the other, in the container, best of 2 repetitions

  3. Berg Balance Scale [ Time Frame: 20 minutes ]
    14 Standardized tests, the Gold standard in Balance testing

  4. Hamburg Quality of Life Questionnaire in Multiple Sclerosis [ Time Frame: 20 minutes ]
    Patient Reported Quality of Life Questionnaire

  5. Expanded Disability Status Scale [ Time Frame: 5 minutes ]
    Gold standard in describing the status of MS

  6. 6 Minutes Walking Test [ Time Frame: 6 minutes ]
    Walking 6 minutes as far the person can walk, static start, walking at normal speed with or without walking aid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons suffering from Multiple Sclerosis that are in physical therapy treatment because of the multiple sclerosis and are treated in private practice or in ambulant department of hospitals in the German part of Switzerland
Criteria

Inclusion Criteria:

  • Patients with a diagnosed MS, who are in physiotherapeutic treatment because of MS, older than 18 year, must be able to read the MSQPT by himself, native language German or French, EDSS score of less or equal 6.5

Exclusion Criteria:

  • Acute episode of MS, grave cognitive changes, bedfast patient, distinct fatigue, able to perform less than 2 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346279


Sponsors and Collaborators
Institut fuer Physiotherapieforschung
Schweizer Physiotherapie Verband physioswiss
Schweizerische Multiple Sklerose Gesellschaft
Investigators
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Principal Investigator: Nanco van der Maas Institut für Physiotherapieforschung

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut fuer Physiotherapieforschung
ClinicalTrials.gov Identifier: NCT02346279     History of Changes
Other Study ID Numbers: Responsivität und MCID MSQPT
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Keywords provided by Institut fuer Physiotherapieforschung:
Multiple Sclerosis
Rehabilitation
Questionnaire
Patient-Reported Outcome
Responsiveness
Minimal Important Clinical Difference
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases