Evaluation of Interoception, Fatigue, and Upper and Lower Extremity Functional Capacity in Multiple Sclerosis Patients With Good and Poor Sleep Quality

Multiple sclerosis (MS) is a chronic disease of the central nervous system associated with a wide range of motor and non-motor symptoms. Sleep disturbances, fatigue, altered interoceptive perception, and impairments in upper and lower extremity functional capacity are commonly observed in individuals with MS. Decreased sleep quality may exacerbate fatigue and negatively affect daily activities and independence. Therefore, examining the relationships between sleep quality, interoception, fatigue, and extremity functional capacity is essential for effective disease management and the preservation of quality of life in individuals with MS.

The aim of this study is to compare interoception, fatigue, and upper and lower extremity functional capacity between individuals with MS who have good and poor sleep quality and to evaluate the relationships among these variables. By comparing MS patients based on sleep quality, this study seeks to clarify the impact of sleep quality on interoceptive processes, fatigue levels, and functional capacity.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye), 06000
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals diagnosed with multiple sclerosis (MS) by a specialist physician. Eligible participants are adults aged 18-65 years, with an Expanded Disability Status Scale (EDSS) score between 1.0 and 5.0, who have not experienced an MS relapse within the past three months. Participants must be able to stand independently for at least 60 seconds without assistive devices and have sufficient cognitive function, defined as a Mini-Mental State Examination score greater than 24. Exclusion criteria include other neurological, visual, or circulatory conditions affecting balance, recent corticosteroid use, pregnancy, significant orthopedic or spinal disorders, and recent medication changes. Written informed consent is obtained from all participants prior to enrollment.

Description

Inclusion Criteria:

• Diagnosed with multiple sclerosis by a specialist physician
• Aged between 18 and 65 years
• No MS relapse within the last 3 months
• Expanded Disability Status Scale (EDSS) score between 1.0 and 5.0
• Ability to stand independently for at least 60 seconds without the use of any assistive device
• No additional neurological disorder or circulatory/visual impairment that may affect balance
• Cognitive function score >24 on the Mini-Mental State Examination (MMSE)
• Provided written informed consent after receiving detailed information about the study

Exclusion Criteria:

• Use of corticosteroids within the last 4 weeks
• Pregnancy
• Presence of spinal deformities, disc herniation, or other spinal pathologies
• Presence of orthopedic conditions affecting the hip, knee, or ankle
• History of surgery involving the spine, hip, knee, or ankle
• Change in medication within the last month

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis Patients with Poor Sleep Quality; Participants with a Pittsburgh Sleep Quality Index (PSQI) total score of 5 or higher, indicating poor sleep quality.
Multiple Sclerosis Patients with Poor Good Quality; Good sleep quality group: Participants with a Pittsburgh Sleep Quality Index (PSQI) total score below 5, indicating good sleep quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index Total Score	Sleep quality refers to the subjective evaluation of sleep characteristics, including sleep duration, latency, efficiency, disturbances, and daytime dysfunction, and was assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A cut-off score of 5 was applied; scores greater than 5 indicate poor sleep quality, whereas scores less than 5 indicate good sleep quality.	From November 1, 2025 to June 1, 2026
Interoceptive Accuracy Score	Interoceptive accuracy refers to the ability to accurately perceive internal bodily signals and was assessed using the Heartbeat Counting Task. During the task, participants were instructed to silently count their own heartbeats without manually checking their pulse during predefined time intervals. Simultaneously, actual heartbeats were recorded using a physiological recording device. Interoceptive accuracy was calculated by comparing the number of counted heartbeats with the recorded heartbeats. Scores range from 0 to 1, with higher scores indicating better interoceptive accuracy.	From November 1, 2025 to June 1, 2026
Fatigue Severity Scale Mean Score	Fatigue severity refers to the perceived intensity and impact of fatigue on daily functioning and was assessed using the Fatigue Severity Scale (FSS). The FSS is a self-report questionnaire consisting of 9 items, each rated on a 7-point Likert scale. The mean score was calculated by averaging the item scores and ranges from 1 to 7, with higher scores indicating greater fatigue severity.	From November 1, 2025 to June 1, 2026
Multiple Sclerosis Functional Composite (MSFC) Composite Score	Functional capacity refers to the ability to perform motor and cognitive tasks related to daily functioning and was assessed using the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. The MSFC is a composite measure consisting of lower extremity function assessed by the Timed 25-Foot Walk, upper extremity function assessed by the 9-Hole Peg Test, and cognitive processing speed assessed by the Paced Auditory Serial Addition Test. Scores from each component were standardized and combined to generate a composite MSFC score, with higher scores indicating better functional capacity.	From November 1, 2025 to June 1, 2026
Interoceptive Awareness Scores	Interoceptive awareness refers to the conscious perception and appraisal of internal bodily sensations and was assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) questionnaire. The MAIA-2 is a self-report measure consisting of 32 items assessing multiple dimensions of interoceptive awareness. Total scores range from 0 to 160, with higher scores indicating better interoceptive awareness.	From November 1, 2025 to June 1, 2026

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: fatigue; Multiple sclerosis; functional capacity; sleep quality; interoception
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Multiple Sclerosis; Fatigue; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 08/1454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No