Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational Assessment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Spasticity, Spasticity With Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- 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.
Primary outcome measures
- Classification of Upper and Lower Extremity Spasticity Patterns [Time frame: Baseline (single study visit)]
Secondary outcome measures (4)
- Impact of Spasticity on Quality of Life [Time frame: Baseline (single study visit)]
- Lower Extremity Functional Performance [Time frame: Baseline (single study visit)]
- Upper Extremity Manual Dexterity [Time frame: Baseline (single study visit)]
- Spasticity Severity Assessed by the Modified Ashworth Scale [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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
- Absence of significant cognitive impairment
Exclusion criteria
- 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
- Inability or unwillingness to provide informed consent
- Presence of cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854 — Istanbul
Identifiers
NCT: NCT07466823 · MarmaraU-FTR-SKA-1