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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07374237
Enrollment
102
Registered
2026-01-28
Start date
2025-11-01
Completion date
2026-03-15
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, interoception, fatigue, functional capacity, sleep quality

Brief summary

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.

Interventions

None listed

Sponsors

Gulhane School of Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index Total ScoreFrom November 1, 2025 to June 1, 2026Sleep 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.
Interoceptive Accuracy ScoreFrom November 1, 2025 to June 1, 2026Interoceptive 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.
Fatigue Severity Scale Mean ScoreFrom November 1, 2025 to June 1, 2026Fatigue 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.
Multiple Sclerosis Functional Composite (MSFC) Composite ScoreFrom November 1, 2025 to June 1, 2026Functional 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.
Interoceptive Awareness ScoresFrom November 1, 2025 to June 1, 2026Interoceptive 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026