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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02346279
Enrollment
81
Registered
2015-01-26
Start date
2011-04-30
Completion date
2013-10-31
Last updated
2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Rehabilitation, Questionnaire, Patient-Reported Outcome, Responsiveness, Minimal Important Clinical Difference

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.

Interventions

OTHERQuestionnaires, 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

Sponsors

Schweizer Physiotherapie Verband physioswiss
CollaboratorUNKNOWN
Schweizerische Multiple Sklerose Gesellschaft
CollaboratorOTHER
Institut fuer Physiotherapieforschung
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Multiple Sclerosis Questionnaire for Physical Therapists20 minutesItems 'Taking a Shower', 'Getting in and out of a car', 'Walking distance' and Walking Time', Activity Group, Participation Group, Total Sum of Items

Secondary

MeasureTime frameDescription
Nine Hole Peg Testup to 5 minutesPutting 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 Scale20 minutes14 Standardized tests, the Gold standard in Balance testing
6 Meter Timed Walking Test3 to 20 secondsWalking 6 Meter, static start, walking at normal speed with or without an walking aid, average of three repetitions
Expanded Disability Status Scale5 minutesGold standard in describing the status of MS
6 Minutes Walking Test6 minutesWalking 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 Sclerosis20 minutesPatient Reported Quality of Life Questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026