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Starting soon Observational

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

NCT07654738 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-08-31
Last updated
2026-09-08

Condition(s) studied

Demyelinating Diseases of the Central Nervous SystemChildCore StabilityBalanceFatigue

Investigational drug(s) / intervention(s)

No ADT

No 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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
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

Primary outcome measure(s)

  • Core Stability — Baseline (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.

Trial sites (1)

FacilityCityRegionStatus
Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye Istanbul Basaksehir
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07654738 on ClinicalTrials.gov ↗ ← All trials in Turkey