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

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

Sponsors

Lead sponsor: Institut fuer Physiotherapieforschung

Collaborator: Schweizer Physiotherapie Verband physioswiss
Schweizerische Multiple Sklerose Gesellschaft

Source 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.

Overall Status Completed
Start Date April 2011
Completion Date October 2013
Primary Completion Date October 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Multiple Sclerosis Questionnaire for Physical Therapists 20 minutes
Secondary Outcome
Measure Time Frame
6 Meter Timed Walking Test 3 to 20 seconds
Nine Hole Peg Test up to 5 minutes
Berg Balance Scale 20 minutes
Hamburg Quality of Life Questionnaire in Multiple Sclerosis 20 minutes
Expanded Disability Status Scale 5 minutes
6 Minutes Walking Test 6 minutes
Enrollment 81
Condition
Intervention

Intervention type: Other

Intervention name: Questionnaires, EDSS, physical test

Description: 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

Arm group label: Persons in physical therapy treatment

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Nanco van der Maas Principal Investigator Institut für Physiotherapieforschung
Verification Date

January 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Persons in physical therapy treatment

Description: Questionnaires (MSQPT, HAQUAMS, Transition Questionnaire for Patient and treating physiotherapist), physical tests (9HPT, 6MTWT, BBS, 6MWT), EDSS

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov