An observational study in Multiple Sclerosis, Spasticity and Spasticity With Multiple Sclerosis, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Marmara University · Observational
Multiple sclerosis (MS) is a chronic neurological disease frequently associated with spasticity, which may lead to functional limitations and reduced quality of life. Although spasticity is common in MS, detailed descriptions of upper and lower extremity spasticity patterns are limited. A better understanding of spasticity patterns may help improve individualized rehabilitation and treatment planning.
The aim of this study is to classify upper and lower extremity spasticity patterns in patients with multiple sclerosis and to investigate their association with quality of life. Adult patients with MS and clinical spasticity will be recruited from a tertiary care outpatient clinic. Spasticity will be evaluated using the Modified Ashworth Scale, and extremity postures will be recorded to define spasticity patterns. Functional performance will be assessed using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM).
This prospective cross-sectional study is designed to provide a systematic description of spasticity patterns in patients with multiple sclerosis and to examine their relationship with functional outcomes and quality of life.
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system characterized by motor and sensory impairments, fatigue, balance disorders, and spasticity. Spasticity is one of the most common motor symptoms in MS and affects approximately 60% of patients, with higher prevalence in advanced stages of the disease. Spasticity contributes to functional limitations, pain, gait disturbances, and reduced quality of life.
Despite the high prevalence of spasticity in MS, the characterization of spasticity patterns remains limited. Most studies on spasticity patterns have focused on stroke populations, and data specific to multiple sclerosis are scarce. However, clinical observations suggest that spasticity patterns in MS differ from those seen in other upper motor neuron disorders. A systematic description of upper and lower extremity spasticity patterns may improve clinical decision-making and support individualized rehabilitation and botulinum toxin treatment strategies.
The primary objective of this study is to develop a classification of lower extremity spasticity patterns based on limb postures in patients with multiple sclerosis. Secondary objectives include evaluating upper extremity spasticity patterns and investigating the relationship between spasticity patterns and quality of life.
This prospective cross-sectional study will be conducted at Marmara University Pendik Training and Research Hospital. Adult patients diagnosed with multiple sclerosis according to the 2024 McDonald criteria and presenting with clinical spasticity will be recruited consecutively from neurology and physical medicine and rehabilitation outpatient clinics.
Demographic and clinical data including age, sex, disease duration, MS subtype, and previous spasticity treatments will be recorded. Spasticity will be assessed using the Modified Ashworth Scale. Upper extremity spasticity patterns will be evaluated at the shoulder, elbow, forearm, wrist, and hand levels. Lower extremity spasticity patterns will be evaluated at the hip, knee, and ankle levels.
Functional performance will be assessed using the Timed 25-Foot Walk Test for participants with lower extremity spasticity and the 9-Hole Peg Test for participants with upper extremity spasticity. Disability level will be recorded using the Expanded Disability Status Scale. The impact of spasticity on daily life and psychosocial status will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM).
The results of this study are expected to provide a comprehensive description of spasticity patterns in multiple sclerosis and to improve the understanding of their clinical and functional relevance.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 75 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.
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Adult patients with multiple sclerosis and clinical spasticity will be recruited consecutively from the Multiple Sclerosis outpatient clinic of Marmara University Pendik Training and Research Hospital and from patients referred to the Physical Medicine and Rehabilitation outpatient clinic. Eligible participants will undergo clinical evaluation during a single study visit.
Exclusion Criteria:
Adult patients with multiple sclerosis and clinical spasticity will be evaluated in a single study visit. Spasticity patterns of the upper and lower extremities will be assessed using the Modified Ashworth Scale and limb posture evaluation. Functional performance will be evaluated using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be assessed using the Patient-Reported Impact of Spasticity Measure (PRISM).
Other: Observational Assessment
This is an observational study without therapeutic intervention. Participants will undergo clinical assessment of spasticity patterns, functional performance tests, and patient-reported outcome measures during a single study visit.
Classification of Upper and Lower Extremity Spasticity Patterns
Upper and lower extremity spasticity patterns will be classified based on limb postures and spasticity severity assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive muscle stretching and is scored from 0 to 4 (0 = no increase in muscle tone; 1 = slight increase in muscle tone; 1+ = slight increase in tone with minimal resistance through less than half of the range of motion; 2 = more marked increase in tone through most of the range of motion; 3 = considerable increase in muscle tone; 4 = affected part rigid in flexion or extension). Higher scores indicate greater spasticity. Spasticity will be evaluated at the shoulder, elbow, forearm, wrist, and hand for the upper extremity and at the hip, knee, and ankle for the lower extremity. Based on these assessments, patients will be categorized according to their upper and lower extremity spasticity patterns.
Time frame: Baseline (single study visit)
Impact of Spasticity on Quality of Life
The impact of spasticity on quality of life will be assessed using the Patient-Reported Impact of Spasticity Measure (PRISM). The PRISM is a patient-reported outcome measure with a total score ranging from 0 to 164, where higher scores indicate a greater negative impact of spasticity on daily life and psychosocial functioning.
Time frame: Baseline (single study visit)
Lower Extremity Functional Performance
Lower extremity function will be assessed using the Timed 25-Foot Walk Test. Participants will walk a distance of 7.62 meters twice, and the average completion time in seconds will be recorded.
Time frame: Baseline (single study visit)
Upper Extremity Manual Dexterity
Upper extremity manual dexterity will be assessed using the 9-Hole Peg Test. The test will be performed twice for each hand, and the average completion time in seconds will be recorded.
Time frame: Baseline (single study visit)
Spasticity Severity Assessed by the Modified Ashworth Scale
Spasticity severity will be assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive muscle stretching and is scored from 0 to 4 (0 = no increase in muscle tone; 1 = slight increase in muscle tone; 1+ = slight increase in tone with minimal resistance through less than half of the range of motion; 2 = more marked increase in tone through most of the range of motion; 3 = considerable increase in muscle tone; 4 = affected part rigid in flexion or extension). Higher scores indicate greater spasticity severity. Spasticity will be evaluated in the shoulder, elbow, forearm, wrist, and hand for the upper extremity and in the hip, knee, and ankle for the lower extremity.
Time frame: Baseline
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