Multiple SclerosisNCT03603691
Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With MS
A study testing Modified Manual Muscle Test, BMRC manual muscle test and MicroFET2 handhold dynamometer in people with Multiple Sclerosis, run by Nanco van der Maas at 1 site in Switzerland.
Trial summary
Many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. It can be evaluated with a variety of muscle function tests. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing… 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?
- Modified Manual Muscle Test, BMRC manual muscle test and MicroFET2 handhold dynamometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 29 Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- diagnosed with MS according to the McDonald criteria
- EDSS between 0 and 6.5
- older than 18 years of age.
Who cannot join
- An acute episode of MS within 3 months prior to the testing,
- grave cognitive changes
- distinct fatigue
- a history of current back, neck or elbow pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Prospective, Cross-sectional Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With Multiple Sclerosis) (MS)
Many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. It can be evaluated with a variety of muscle function tests. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients.
The investigators aim to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the 6 level British Medical Research Council (BMRC) manual muscle test and the microFET2 handhold dynamometer.
Read the detailed description
Background In Switzerland, many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. Particularly in progressive disease courses, motor dysfunction is a major contributor to the reduced mobility and quality of life. Therefore, improving the motor dysfunction is an important goal for therapy and is evaluated with a variety of muscle function tests. The 6 level British Medical Research Council (BMRC) manual muscle test is the most widely used test in MS and is a part of the Neurostatus-Expanded Disability Status Scale (EDSS) assessment, which has been adopted as the standard in most of the pivotal trials that have led to the approval of the current MS treatments. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients.
Aim of the study is to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the Neurostatus BMRC manual muscle test and the microFET2 handhold dynamometer.
Methods This is a single-centre, prospective cross-sectional study with a test-retest design. The Neurostatus BMRC manual muscle test and the microFET2 hand held dynamometer are used as the criteria. The primary endpoint is the ordinal MMMT level. The intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The investigator aims to show that the MMMT results are clinically relevant with a high level of ICC.
The secondary endpoints include the Neurostatus BMRC levels, the muscle strength as measured by the microFET2 dynamometer and fatigue using a numeric rating scale (NRS). Subgroup analyses will determine whether the MMMT is less sensitive to the influence of spasticity than the Neurostatus BMRC.
28 patients with MS will be tested in 2 days. In each day, six examiners will test seven patients in the morning and seven patients in the afternoon. Three MS-therapists from the Specialized Group Physiotherapy in MS and three neurologists from the Department of Neurology at the University Hospital Basel will be tester. All examiners will be blinded to the results of the other examiners. All test persons will be blinded to their test results. First, the patient will rate his fatigue using the NRS. Muscle function will be tested with the microFET2 and spasticity will be assessed using the modified Tardieu Scale. Then, the first round of manual testing will be executed. After each test, there will be a break that is long enough for the patients to recuperate. The order of the examiners will be randomized. The retest round will proceed in a different order. Finally, spasticity will be tested again using the modified Tardieu Scale, and the patients will rate their fatigue.
Statistical Analysis The study data will be analysed using the internet-based program R. The descriptive statistics will describe the sample characteristics. The inter-rater reliability will be estimated by the ICC of the MMMT ranks. The ICC will be estimated by a two-way random-effects ANOVA and reported with 95% CI. If the lower limit of the CI is larger than the pre-specified clinically relevant ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients.
The inter-rater reliability the Neurostatus BMRC will be estimated similarly by the ICC. The ICC of both tests will be compared. The test-retest reliability of the MMMT and Neurostatus BMRC will be estimated using two-way random-effects ANOVA and will be reported by ICC estimates. The influence of potential fatigue will be analysed by plotting the test and retest results against the NRS and investigating the associations and interactions using a linear mixed effects model. The pairwise correlations of the MMMT and the Neurostatus BMRC with the microFET2 will be graphically analysed (scatterplots and/or boxplots), and Spearman's ρ will be calculated. The primary and secondary analyses will be repeated for subgroups with high and low spasticity patients to compare the sensitivity of the MMMT and Neurostatus BMRC to spasticity.
Expected results: The investigators expect the MMMT for MS to be a reliable and valid manual muscle function test that can be used in the evaluation of the long-term treatment of MS patients with physical therapy.
- Conditions
- Multiple Sclerosis
- Being tested
- Modified Manual Muscle Test, BMRC manual muscle test, MicroFET2 handhold dynamometer, Modified Tardieu Scale, Fatigue Scale for Motor and Cognitive Functions
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Manual Muscle TestDiagnostic test
Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance
BMRC manual muscle testDiagnostic test
muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle
MicroFET2 handhold dynamometerDiagnostic test
MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups
Modified Tardieu ScaleDiagnostic test
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement
Fatigue Scale for Motor and Cognitive FunctionsDiagnostic test
Measures cognitive and motor fatigue for people with MS
numeric rating scale FatigueDiagnostic test
visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)
| Study group | Role | What they receive |
|---|---|---|
| Modified Manual Muscle Test | Active comparator | The MMMT will be tested in a test-retest design Receives: Diagnostic Test: Modified Manual Muscle Test; Diagnostic Test: BMRC manual muscle test; Diagnostic Test: MicroFET2 handhold dynamometer; Diagnostic Test: Modified Tardieu Scale; Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions; Diagnostic Test: numeric rating scale Fatigue |
| Neurostatus BMRC | Active comparator | The Neurostatus BMRC measures Strength and will be used in a test-retest design Receives: Diagnostic Test: Modified Manual Muscle Test; Diagnostic Test: BMRC manual muscle test; Diagnostic Test: MicroFET2 handhold dynamometer; Diagnostic Test: Modified Tardieu Scale; Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions; Diagnostic Test: numeric rating scale Fatigue |
| MicroFET2 | Active comparator | The MicroFET2 is a hand held dynamometer to measure strength Receives: Diagnostic Test: Modified Manual Muscle Test; Diagnostic Test: BMRC manual muscle test; Diagnostic Test: MicroFET2 handhold dynamometer; Diagnostic Test: Modified Tardieu Scale; Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions; Diagnostic Test: numeric rating scale Fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability Modified Manual Muscle Test
The primary endpoint is the MMMT level. The ordinal levels (2+, 3-, 3, 4-, 4, 4+ and 5) will be transformed to ranks (1-7), and the intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The aim is to show that the MMMT results are at a clinically relevant - thus high - level of ICC (that is a pre-specified, clinically relevant level the ICC margin).
The null hypothesis is that the lower limit of the 95% confidence interval (CI) of the ICC is smaller than or equal to the ICC margin. The alternative hypothesis is that the lower limit of the 95% CI of the ICC is larger than the ICC margin.
If the lower limit of the CI is larger than the ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients.
Measured: Baseline
Secondary outcomes (3)
Intra-rater reliability Modified Manual Muscle Test
The intra-rater reliability will be evaluated by comparing the test results of two tests (test-retest), which will be executed by the same tester. The two tests will be executed on the same day within 4 hours. The intra-class correlation coefficient of the ranked MMMT levels (analogue to the primary endpoint) will be used to describe the intra-rater reliability of the MMMT.
Measured: Baseline- Baseline plus 4 hours
Validity of the Modified Manual Muscle Test
The inter-rater reliability of the BMRC will be measured by the ICC. The ICC of the BMRC will be estimated and analysed as previously described for the primary analysis. The ICCs of the MMMT and the BMRC will be compared descriptively.
The test-retest reliability of the MMMT and the BMRC will be estimated for each rater separately using a two-way random-effects ANOVA, including the patient and "test type" (test/retest) as random effects. The ICC estimates will be reported with the 95% CI and compared descriptively between the raters using the same test and between the tests (MMMT vs BMRC).
The pairwise correlations of the MMMT and the BMRC with the muscle strength as assessed by the microFET2 will be investigated graphically (scatterplots and/or boxplots). Furthermore, Spearman's rank correlation coefficient will be presented with the corresponding 95% CI and p-values.
Measured: Baseline- Baseline plus 4 hours
Modified Tardieu Scale level
The BMRC has 6 levels, which makes the scale robust and reliable but insensitive to change. In addition, the BMRC does not consider spasticity. The MMMT has 12 levels, which makes it more sensitive, but it also might mean that the scale is less reliable. Because the MMMT considers spasticity, we expect that this compensates for the possible loss of reliability. It is assumed that the MMMT is less sensitive to spasticity than the BMRC. Thus, for patients with a different level of spasticity measured by the Modified Tardieu Scale, both the inter-rater and the test-retest reliability of the MMMT are expected to be equal to those of the BMRC.
The primary and secondary analyses will thus be repeated for the subgroups of high-spasticity and low-spasticity patients separately (assuming that a reasonable number of patients per subgroup and endpoint are available).
Measured: Baseline- Baseline plus 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Aug 2018
- Primary completion15 Dec 2018
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, cross-sectional and test-retest
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanco van der Maas
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Physiotherapie Langmatten Binningen, Switzerland, Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor-investigator, Nanco van der Maas, Institut fuer Physiotherapieforschung
- Investigators
- Nico van der Maas, Principal investigator, Institute for Physiotherapy Research, Biel, SwitzerlandMarcus Dsouza, Dr. med., Principal investigator, University Hospital Basle, Basle, SwitzerlandRegula Steinlin Egli, Principal investigator, Specialized Group Physiotherapy in MS, Binningen, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603691
- Sponsor's protocol ID
- 2018-01103; me16Kappos3
- Other IDs
- 2018
- Status last verified
- Jan 2019
- First submitted
- 19 Jun 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Prospective, Cross-sectional Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With Multiple Sclerosis) (MS)
- ClinicalTrials.gov ID
- NCT03603691
- Acronym / sponsor ID
- 2018-01103; me16Kappos3
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nanco van der MaasUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Physiotherapie Langmatten Binningen, Switzerland, Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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.
Many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. It can be evaluated with a variety of muscle function tests. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients.
The investigators aim to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the 6 level British Medical Research Council (BMRC) manual muscle test and the microFET2 handhold dynamometer.
Detailed description
Background In Switzerland, many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. Particularly in progressive disease courses, motor dysfunction is a major contributor to the reduced mobility and quality of life. Therefore, improving the motor dysfunction is an important goal for therapy and is evaluated with a variety of muscle function tests. The 6 level British Medical Research Council (BMRC) manual muscle test is the most widely used test in MS and is a part of the Neurostatus-Expanded Disability Status Scale (EDSS) assessment, which has been adopted as the standard in most of the pivotal trials that have led to the approval of the current MS treatments. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients.
Aim of the study is to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the Neurostatus BMRC manual muscle test and the microFET2 handhold dynamometer.
Methods This is a single-centre, prospective cross-sectional study with a test-retest design. The Neurostatus BMRC manual muscle test and the microFET2 hand held dynamometer are used as the criteria. The primary endpoint is the ordinal MMMT level. The intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The investigator aims to show that the MMMT results are clinically relevant with a high level of ICC.
The secondary endpoints include the Neurostatus BMRC levels, the muscle strength as measured by the microFET2 dynamometer and fatigue using a numeric rating scale (NRS). Subgroup analyses will determine whether the MMMT is less sensitive to the influence of spasticity than the Neurostatus BMRC.
28 patients with MS will be tested in 2 days. In each day, six examiners will test seven patients in the morning and seven patients in the afternoon. Three MS-therapists from the Specialized Group Physiotherapy in MS and three neurologists from the Department of Neurology at the University Hospital Basel will be tester. All examiners will be blinded to the results of the other examiners. All test persons will be blinded to their test results. First, the patient will rate his fatigue using the NRS. Muscle function will be tested with the microFET2 and spasticity will be assessed using the modified Tardieu Scale. Then, the first round of manual testing will be executed. After each test, there will be a break that is long enough for the patients to recuperate. The order of the examiners will be randomized. The retest round will proceed in a different order. Finally, spasticity will be tested again using the modified Tardieu Scale, and the patients will rate their fatigue.
Statistical Analysis The study data will be analysed using the internet-based program R. The descriptive statistics will describe the sample characteristics. The inter-rater reliability will be estimated by the ICC of the MMMT ranks. The ICC will be estimated by a two-way random-effects ANOVA and reported with 95% CI. If the lower limit of the CI is larger than the pre-specified clinically relevant ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients.
The inter-rater reliability the Neurostatus BMRC will be estimated similarly by the ICC. The ICC of both tests will be compared. The test-retest reliability of the MMMT and Neurostatus BMRC will be estimated using two-way random-effects ANOVA and will be reported by ICC estimates. The influence of potential fatigue will be analysed by plotting the test and retest results against the NRS and investigating the associations and interactions using a linear mixed effects model. The pairwise correlations of the MMMT and the Neurostatus BMRC with the microFET2 will be graphically analysed (scatterplots and/or boxplots), and Spearman's ρ will be calculated. The primary and secondary analyses will be repeated for subgroups with high and low spasticity patients to compare the sensitivity of the MMMT and Neurostatus BMRC to spasticity.
Expected results: The investigators expect the MMMT for MS to be a reliable and valid manual muscle function test that can be used in the evaluation of the long-term treatment of MS patients with physical therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, cross-sectional and test-retest
| Arm | Type | Receives |
|---|---|---|
| Modified Manual Muscle Test | Active comparator | Diagnostic Test: Modified Manual Muscle Test, Diagnostic Test: BMRC manual muscle test, Diagnostic Test: MicroFET2 handhold dynamometer, Diagnostic Test: Modified Tardieu Scale, Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions, Diagnostic Test: numeric rating scale FatigueThe MMMT will be tested in a test-retest design |
| Neurostatus BMRC | Active comparator | Diagnostic Test: Modified Manual Muscle Test, Diagnostic Test: BMRC manual muscle test, Diagnostic Test: MicroFET2 handhold dynamometer, Diagnostic Test: Modified Tardieu Scale, Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions, Diagnostic Test: numeric rating scale FatigueThe Neurostatus BMRC measures Strength and will be used in a test-retest design |
| MicroFET2 | Active comparator | Diagnostic Test: Modified Manual Muscle Test, Diagnostic Test: BMRC manual muscle test, Diagnostic Test: MicroFET2 handhold dynamometer, Diagnostic Test: Modified Tardieu Scale, Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions, Diagnostic Test: numeric rating scale FatigueThe MicroFET2 is a hand held dynamometer to measure strength |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with MS according to the McDonald criteria
- EDSS between 0 and 6.5
- older than 18 years of age.
Key exclusion criteria (4 listed)
- An acute episode of MS within 3 months prior to the testing,
- grave cognitive changes
- distinct fatigue
- a history of current back, neck or elbow pain
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 |
|---|---|---|
| Modified Manual Muscle TestManual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance | Diagnostic test | MicroFET2, Modified Manual Muscle Test, Neurostatus BMRC |
| BMRC manual muscle testmuscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle | Diagnostic test | MicroFET2, Modified Manual Muscle Test, Neurostatus BMRC |
| MicroFET2 handhold dynamometerMicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups | Diagnostic test | MicroFET2, Modified Manual Muscle Test, Neurostatus BMRC |
| Modified Tardieu ScaleModified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement | Diagnostic test | MicroFET2, Modified Manual Muscle Test, Neurostatus BMRC |
| Fatigue Scale for Motor and Cognitive FunctionsMeasures cognitive and motor fatigue for people with MS | Diagnostic test | MicroFET2, Modified Manual Muscle Test, Neurostatus BMRC |
| numeric rating scale Fatiguevisual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue) | Diagnostic test | MicroFET2, Modified Manual Muscle Test, Neurostatus BMRC |
Primary outcome
Inter-rater reliability Modified Manual Muscle Test
Time frame: Baseline
The primary endpoint is the MMMT level. The ordinal levels (2+, 3-, 3, 4-, 4, 4+ and 5) will be transformed to ranks (1-7), and the intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The aim is to show that the MMMT results are at a clinically relevant - thus high - level of ICC (that is a pre-specified, clinically relevant level the ICC margin). The null hypothesis is that the lower limit of the 95% confidence interval (CI) of the ICC is smaller than or equal to the ICC margin. The alternative hypothesis is that the lower limit of the 95% CI of the ICC is larger than the ICC margin. If the lower limit of the CI is larger than the ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients.
3 secondary outcomes
Intra-rater reliability Modified Manual Muscle Test
Time frame: Baseline- Baseline plus 4 hours
Validity of the Modified Manual Muscle Test
Time frame: Baseline- Baseline plus 4 hours
Modified Tardieu Scale level
Time frame: Baseline- Baseline plus 4 hours
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 30 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Nico van der Maas principal investigator
Institute for Physiotherapy Research, Biel, Switzerland
Marcus Dsouza, Dr. med. principal investigator
University Hospital Basle, Basle, Switzerland
Regula Steinlin Egli principal investigator
Specialized Group Physiotherapy in MS, Binningen, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Manual Muscle Test, BMRC manual muscle test and MicroFET2 handhold dynamometer in people with Multiple Sclerosis, run by Nanco van der Maas at 1 site in Switzerland.
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 3 inclusion and 4 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Inter-rater reliability Modified Manual Muscle Test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2019.