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Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases

Investigation of the Relationship Between Core Stability, Functional Capacity, Balance, Lower Extremity Strength, and Fatigue in Pediatric Demyelinating Diseases

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07654738
Acronym
PEDI-CORE
Enrollment
32
Registered
2026-06-17
Start date
2026-08-31
Completion date
2028-01-30
Last updated
2026-09-08

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

Conditions

Balance, Child, Core Stability, Demyelinating Diseases of the Central Nervous System, Fatigue

Keywords

Pediatric Demyelinating Diseases, Core Stability, Balance, Fatigue

Brief summary

This study aims to evaluate balance ability, core stability, functional capacity, lower extremity muscle strength, and fatigue levels in children diagnosed with central nervous system demyelinating diseases, in order to contribute to the development of evidence-based and individualized rehabilitation strategies.

Detailed description

Central nervous system demyelinating diseases in childhood, including multiple sclerosis, neuromyelitis optica spectrum disorder, and acute disseminated encephalomyelitis, are rare but may result in significant physical and cognitive impairments. These conditions arise from immune-mediated damage to the white matter of the brain, optic nerve, and spinal cord, leading to disruptions in neuromotor development. Motor dysfunction, fatigue, and reduced physical activity are commonly observed in affected children and are associated with decreased functional capacity and quality of life. In addition, impaired postural stability due to disrupted integration of proprioceptive, vestibular, and visual systems contributes to balance deficits, increased fall risk, gait abnormalities, and reduced participation in daily activities. Core stabilization plays a fundamental role in motor development and functional movement by ensuring efficient postural control and force transfer through the kinetic chain. However, central nervous system pathology may impair the timely and coordinated activation of core musculature. Despite growing literature in adult populations, pediatric evidence remains limited, which restricts the development of individualized rehabilitation approaches. Therefore, this study will assess balance, core stability, functional capacity, lower extremity muscle strength, and fatigue in children with demyelinating diseases to better inform clinical rehabilitation strategies.

Interventions

OTHERNo ADT

No intervention is administered. Participants will undergo a single assessment including balance evaluation, core stability testing, lower extremity muscle strength assessment, functional capacity tests, and fatigue measurement. All assessments are non-invasive and performed in a single session.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

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

Inclusion criteria

* Age between 6 and 18 years * Diagnosed with a pediatric demyelinating disease * No relapse within the last 3 months * No botulinum toxin (Botox) injections within the last 3 months * No corticosteroid treatment within the last 3 months * Ability to read and write

Exclusion criteria

* History of concomitant autoimmune diseases * Refusal of the patient and/or caregiver to participate in the study * History of another primary neurological disease * Cognitive impairment that limits understanding of instructions and participation in assessments * Visual and/or hearing impairments that interfere with activities of daily living * Presence of additional rheumatological conditions that may interfere with assessments * Spasticity grade ≥2 according to the Modified Ashworth Scale in any muscle group

Design outcomes

Primary

MeasureTime frameDescription
Core StabilityBaseline (single assessment)Core stability (endurance and strength) will be evaluated using standardized trunk endurance tests. The Trunk Flexor Endurance Test measures the duration participants can maintain a 60° trunk flexion position. The Biering-Sørensen Test evaluates trunk extensor endurance in a prone horizontal position supported at the pelvis and lower limbs, recording the time until loss of horizontal alignment. The Side Bridge Test assesses lateral trunk endurance while maintaining a side plank position. All results will be recorded in seconds.
Modified Star Excursion Balance Test (mSEBT)Baseline (single assessment)The Modified Star Excursion Balance Test (mSEBT) will be used to assess dynamic postural control. The test consists of three reach directions: anterior, posteromedial, and posterolateral, with the posterior directions positioned at 90° to each other and each forming a 135° angle with the anterior direction. Participants will stand barefoot on the tested limb at the intersection of the three lines and reach as far as possible along each direction with the contralateral limb while maintaining balance and without transferring body weight onto the reaching limb. Before testing, standardized practice trials will be provided to minimize learning effects. Three recorded trials will be performed in each direction for each limb, and the maximum reach distance will be recorded. Reach distances will be normalized to limb length and expressed as a percentage using the formula: (maximum reach distance / limb length) × 100. A composite reach score will also be calculated by averaging the normalized
6-Minute Walk Test (6MWT)Baseline (single assessment)Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) following standardized protocols. Participants will walk at their own pace for 6 minutes on a 30-meter indoor walkway marked every 2 meters, with turnaround points marked by cones. The total distance walked in meters will be recorded.
Timed Up and Go Test (TUG)Baseline (Single Assessment)For TUG, the person gets up from the chair, walks 3 m, turns back and sits down again. The test will be conducted using the same chair for every child, and the time will be recorded in seconds.

Secondary

MeasureTime frameDescription
30-Second Sit-to-Stand TestBaseline (single assessment)Lower extremity muscle strength and functional performance will be assessed using the 30-Second Sit-to-Stand Test. Participants will perform repeated sit-to-stand movements from a standardized chair for 30 seconds. The total number of full stands completed within the time period will be recorded.
Fatigue Severity Scale (FSS)Baseline (single assessment)Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item questionnaire rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The final score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.
Fatigue Numeric Rating Scale (NRS-Fatigue)Past 24 hours and past 1 week (single assessment)Fatigue intensity will be measured using a 0-10 Numeric Rating Scale, where 0 indicates no fatigue and 10 indicates worst imaginable fatigue. Participants will report fatigue levels during activity, at rest, and over the last 24 hours, as well as perceived fatigue over the past week.

Countries

Turkey (Türkiye)

Contacts

CONTACTTahire Basak Demir, PhD (c)
tahirebasakdemir@gmail.com+90 (212) 213 64 86

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026