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

NCT07466823 | Recruiting

• 1 other identifier: MarmaraU-FTR-SKA-1
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Spasticity; Spasticity With Multiple Sclerosis

Keywords

Multiple sclerosis; Spasticity; Spasticity patterns; PRISM; Upper extremity spasticity; Lower extremity spasticity

Outcome Measures

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.

  Baseline (single study visit)

Secondary Outcomes (4)

• Impact of Spasticity on Quality of Life

  Baseline (single study visit)

• Lower Extremity Functional Performance

  Baseline (single study visit)

• Upper Extremity Manual Dexterity

  Baseline (single study visit)

• Spasticity Severity Assessed by the Modified Ashworth Scale

  Baseline

Study Arms (1)

Multiple Sclerosis With Spasticity

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

Interventions

Observational Assessment OTHER

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.

Multiple Sclerosis With Spasticity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fatma Saika Kahvecioglu Atabay

CONTACT

+90 5346588929; saikakahvecioglu@gmail.com

Evrim Karadag Saygi

CONTACT

evrimkaradag4@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

TU (1)