Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With MS

January 29, 2019 updated by: Nanco van der Maas

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4055
        • Felix Platter Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • diagnosed with MS according to the McDonald criteria
  • EDSS between 0 and 6.5
  • older than 18 years of age.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Modified Manual Muscle Test
The MMMT will be tested in a test-retest design
Diagnostic test: Modified Manual Muscle Test
Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance
Diagnostic test: BMRC manual muscle test
muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle
Diagnostic test: MicroFET2 handhold dynamometer
MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups
Diagnostic test: Modified Tardieu Scale
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement
Diagnostic test: Fatigue Scale for Motor and Cognitive Functions
Measures cognitive and motor fatigue for people with MS
Diagnostic test: numeric rating scale Fatigue
visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)
Active Comparator: Neurostatus BMRC
The Neurostatus BMRC measures Strength and will be used in a test-retest design
Diagnostic test: Modified Manual Muscle Test
Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance
Diagnostic test: BMRC manual muscle test
muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle
Diagnostic test: MicroFET2 handhold dynamometer
MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups
Diagnostic test: Modified Tardieu Scale
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement
Diagnostic test: Fatigue Scale for Motor and Cognitive Functions
Measures cognitive and motor fatigue for people with MS
Diagnostic test: numeric rating scale Fatigue
visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)
Active Comparator: MicroFET2
The MicroFET2 is a hand held dynamometer to measure strength
Diagnostic test: Modified Manual Muscle Test
Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance
Diagnostic test: BMRC manual muscle test
muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle
Diagnostic test: MicroFET2 handhold dynamometer
MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups
Diagnostic test: Modified Tardieu Scale
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement
Diagnostic test: Fatigue Scale for Motor and Cognitive Functions
Measures cognitive and motor fatigue for people with MS
Diagnostic test: numeric rating scale Fatigue
visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intra-rater reliability Modified Manual Muscle Test
Time Frame: Baseline- Baseline plus 4 hours
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.
Baseline- Baseline plus 4 hours
Validity of the Modified Manual Muscle Test
Time Frame: Baseline- Baseline plus 4 hours

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.
Baseline- Baseline plus 4 hours
Modified Tardieu Scale level
Time Frame: Baseline- Baseline plus 4 hours

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).
Baseline- Baseline plus 4 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bias testing Fatigue
Time Frame: Baseline- Baseline plus 4 hours
The study may be biased by the multiple testing that cause motor fatigue. The test and retest ratings will be plotted against the respective Numeric Rating Scale fatigue (at the beginning or end of the assessment, respectively) and tested for an overall association and interaction using a linear mixed effects model.
Baseline- Baseline plus 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanco van der Maas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Basel, Switzerland
Physiotherapie Langmatten Binningen, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nico van der Maas, Institute for Physiotherapy Research, Biel, Switzerland
  • Principal Investigator: Marcus Dsouza, Dr. med., University Hospital Basle, Basle, Switzerland
  • Principal Investigator: Regula Steinlin Egli, Specialized Group Physiotherapy in MS, Binningen, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-01103; me16Kappos3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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