Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With MS
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)
1 other identifier
interventional
28
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Aug 2018
Shorter than P25 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2019
CompletedJanuary 30, 2019
January 1, 2019
5 months
June 19, 2018
January 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Secondary Outcomes (3)
Intra-rater reliability Modified Manual Muscle Test
Baseline- Baseline plus 4 hours
Validity of the Modified Manual Muscle Test
Baseline- Baseline plus 4 hours
Modified Tardieu Scale level
Baseline- Baseline plus 4 hours
Other Outcomes (1)
Bias testing Fatigue
Baseline- Baseline plus 4 hours
Study Arms (3)
Modified Manual Muscle Test
ACTIVE COMPARATORThe MMMT will be tested in a test-retest design
Neurostatus BMRC
ACTIVE COMPARATORThe Neurostatus BMRC measures Strength and will be used in a test-retest design
MicroFET2
ACTIVE COMPARATORThe MicroFET2 is a hand held dynamometer to measure strength
Interventions
Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance
muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle
MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement
Measures cognitive and motor fatigue for people with MS
visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)
Eligibility Criteria
You may qualify if:
- diagnosed with MS according to the McDonald criteria
- EDSS between 0 and 6.5
- older than 18 years of age.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Felix Platter Hospital
Basel, 4055, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- the outcome assessors will be blinded for the results of other assessors.
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
June 19, 2018
First Posted
July 27, 2018
Study Start
August 1, 2018
Primary Completion
December 15, 2018
Study Completion
January 29, 2019
Last Updated
January 30, 2019
Record last verified: 2019-01