Multiple SclerosisNCT02346279
Responsiveness and Minimal Clinical Important Difference of the Multiple Sclerosis Questionnaire for Physiotherapists
An observational study of Multiple Sclerosis, run by Institut fuer Physiotherapieforschung.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Questionnaires, EDSS, physical test
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons suffering from Multiple Sclerosis that are in physical therapy treatment because of the multiple sclerosis and are treated in private practice or in ambulant department of hospitals in the German part of Switzerland
Who may be able to join
- 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
Who cannot join
- Acute episode of MS, grave cognitive changes, bedfast patient, distinct fatigue, able to perform less than 2 hours
About this study
Official title: Study to Evaluate the Responsiveness and Minimal Clinical Important Difference (MCID) of the 'Multiple Sclerosis Questionnaire for Physiotherapists' (MSQPT)
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Questionnaires, EDSS, physical test
- Keywords
- Multiple Sclerosis, Rehabilitation, Questionnaire, Patient-Reported Outcome, Responsiveness, Minimal Important Clinical Difference
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, EDSS, physical testOther
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
| Study group | Role | What they receive |
|---|---|---|
| Persons in physical therapy treatment | Questionnaires (MSQPT, HAQUAMS, Transition Questionnaire for Patient and treating physiotherapist), physical tests (9HPT, 6MTWT, BBS, 6MWT), EDSS Receives: Other: Questionnaires, EDSS, physical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Questionnaire for Physical Therapists
Items 'Taking a Shower', 'Getting in and out of a car', 'Walking distance' and Walking Time', Activity Group, Participation Group, Total Sum of Items
Measured: 20 minutes
Secondary outcomes (6)
6 Meter Timed Walking Test
Walking 6 Meter, static start, walking at normal speed with or without an walking aid, average of three repetitions
Measured: 3 to 20 seconds
Nine Hole Peg Test
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
Measured: up to 5 minutes
Berg Balance Scale
14 Standardized tests, the Gold standard in Balance testing
Measured: 20 minutes
Hamburg Quality of Life Questionnaire in Multiple Sclerosis
Patient Reported Quality of Life Questionnaire
Measured: 20 minutes
Expanded Disability Status Scale
Gold standard in describing the status of MS
Measured: 5 minutes
6 Minutes Walking Test
Walking 6 minutes as far the person can walk, static start, walking at normal speed with or without walking aid
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startApr 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer Physiotherapieforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizer Physiotherapie Verband physioswiss, Schweizerische Multiple Sklerose Gesellschaft
- Responsible party
- Sponsor
- Investigators
- Nanco van der Maas, Principal investigator, Institut für Physiotherapieforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346279
- Sponsor's protocol ID
- Responsivität und MCID MSQPT
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2015
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2(14):i-iv, 1-74. No abstract available.
PubMed 9812244Gold SM, Heesen C, Schulz H, Guder U, Monch A, Gbadamosi J, Buhmann C, Schulz KH. Disease specific quality of life instruments in multiple sclerosis: validation of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS). Mult Scler. 2001 Apr;7(2):119-30. doi: 10.1177/135245850100700208.
PubMed 11424632Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f.
PubMed 22315143Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3.
PubMed 18177782Wyrwich KW, Norquist JM, Lenderking WR, Acaster S; Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL). Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res. 2013 Apr;22(3):475-83. doi: 10.1007/s11136-012-0175-x. Epub 2012 Apr 17.
PubMed 22528240van der Maas NA. Patient-reported questionnaires in MS rehabilitation: responsiveness and minimal important difference of the multiple sclerosis questionnaire for physiotherapists (MSQPT). BMC Neurol. 2017 Mar 16;17(1):50. doi: 10.1186/s12883-017-0834-1.
PubMed 28302081
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Responsiveness and Minimal Clinical Important Difference (MCID) of the 'Multiple Sclerosis Questionnaire for Physiotherapists' (MSQPT)
- ClinicalTrials.gov ID
- NCT02346279
- Acronym / sponsor ID
- Responsivität und MCID MSQPT
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Rehabilitation, Questionnaire, Patient-Reported Outcome, Responsiveness, Minimal Important Clinical Difference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Institut fuer PhysiotherapieforschungUniversity, hospital or other
- Collaborators
- Schweizer Physiotherapie Verband physioswiss, Schweizerische Multiple Sklerose Gesellschaft
- Study start
- Apr 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons in physical therapy treatment | – | Other: Questionnaires, EDSS, physical testQuestionnaires (MSQPT, HAQUAMS, Transition Questionnaire for Patient and treating physiotherapist), physical tests (9HPT, 6MTWT, BBS, 6MWT), EDSS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons suffering from Multiple Sclerosis that are in physical therapy treatment because of the multiple sclerosis and are treated in private practice or in ambulant department of hospitals in the German part of Switzerland
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Acute episode of MS, grave cognitive changes, bedfast patient, distinct fatigue, able to perform less than 2 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires, EDSS, physical test6 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 | Other | Persons in physical therapy treatment |
Primary outcome
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 secondary outcomes
6 Meter Timed Walking Test
Time frame: 3 to 20 seconds
Nine Hole Peg Test
Time frame: up to 5 minutes
Berg Balance Scale
Time frame: 20 minutes
Hamburg Quality of Life Questionnaire in Multiple Sclerosis
Time frame: 20 minutes
Expanded Disability Status Scale
Time frame: 5 minutes
6 Minutes Walking Test
Time frame: 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Background: PubMed 9812244Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2(14):i-iv, 1-74. No abstract available.
- Background: PubMed 11424632Gold SM, Heesen C, Schulz H, Guder U, Monch A, Gbadamosi J, Buhmann C, Schulz KH. Disease specific quality of life instruments in multiple sclerosis: validation of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS). Mult Scler. 2001 Apr;7(2):119-30. doi: 10.1177/135245850100700208.
- Background: PubMed 22315143Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f.
- Background: PubMed 18177782Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3.
- Background: PubMed 22528240Wyrwich KW, Norquist JM, Lenderking WR, Acaster S; Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL). Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res. 2013 Apr;22(3):475-83. doi: 10.1007/s11136-012-0175-x. Epub 2012 Apr 17.
- Derived from this study: PubMed 28302081van der Maas NA. Patient-reported questionnaires in MS rehabilitation: responsiveness and minimal important difference of the multiple sclerosis questionnaire for physiotherapists (MSQPT). BMC Neurol. 2017 Mar 16;17(1):50. doi: 10.1186/s12883-017-0834-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanco van der Maas principal investigator
Institut für Physiotherapieforschung
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Institut fuer Physiotherapieforschung.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Questionnaire for Physical Therapists (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346279, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.