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
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Other: Questionnaires, EDSS, physical test|
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.
|Study Type :||Observational|
|Actual Enrollment :||81 participants|
|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|
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
- 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
- 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
- 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
- Berg Balance Scale [ Time Frame: 20 minutes ]14 Standardized tests, the Gold standard in Balance testing
- Hamburg Quality of Life Questionnaire in Multiple Sclerosis [ Time Frame: 20 minutes ]Patient Reported Quality of Life Questionnaire
- Expanded Disability Status Scale [ Time Frame: 5 minutes ]Gold standard in describing the status of MS
- 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
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
|Principal Investigator:||Nanco van der Maas||Institut für Physiotherapieforschung|