Skip to main content
OpenTrials
Completed

NCT Number: NCT02346279

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires, EDSS, physical test

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut fuer Physiotherapieforschung

Other

Collaborators

  • Schweizer Physiotherapie Verband physioswiss
  • Schweizerische Multiple Sklerose Gesellschaft

Registry information

Official study title

Study to Evaluate the Responsiveness and Minimal Clinical Important Difference (MCID) of the 'Multiple Sclerosis Questionnaire for Physiotherapists' (MSQPT)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2015
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.