About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of multiple sclerosis according to the 2024 McDonald criteria
Age ≥ 18 years
Presence of clinical spasticity defined as Modified Ashworth Scale score ≥ 1 in at least one joint
Ability to understand study procedures and provide informed consent
Disqualifiers
Presence of orthopedic, rheumatologic, or neurological conditions affecting movement other than multiple sclerosis
Botulinum toxin type A injection within the previous 3 months
Previous surgical treatment for upper extremity spasticity
Bone deformities affecting the upper extremity
Trial population
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.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Observational Assessment
Other interventionThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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