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

March 29, 2026 updated by: Marmara University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Classification of Upper and Lower Extremity Spasticity Patterns
Time Frame: Baseline (single study visit)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower Extremity Functional Performance
Time Frame: Baseline (single study visit)
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.
Baseline (single study visit)
Upper Extremity Manual Dexterity
Time Frame: Baseline (single study visit)
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.
Baseline (single study visit)
Spasticity Severity Assessed by the Modified Ashworth Scale
Time Frame: Baseline

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.
Baseline
Impact of Spasticity on Quality of Life
Time Frame: Baseline (single study visit)
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.
Baseline (single study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MarmaraU-FTR-SKA-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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