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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT02346279
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-01
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-23
• Last Update Submitted: 2015-01-24
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multiple Sclerosis Questionnaire for Physical Therapists	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

Name	Time	Method
6 Minutes Walking Test	6 minutes	Walking 6 minutes as far the person can walk, static start, walking at normal speed with or without walking aid
Hamburg Quality of Life Questionnaire in Multiple Sclerosis	20 minutes	Patient Reported Quality of Life Questionnaire
Expanded Disability Status Scale	5 minutes	Gold standard in describing the status of MS
6 Meter Timed Walking Test	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	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	20 minutes	14 Standardized tests, the Gold standard in Balance testing