Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observational Assessment

    Other intervention

    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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Multiple Sclerosis With Spasticity1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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

Other outcomes

Sponsors and contacts

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