Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07654738

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

Location contact

Tahire Basak Demir, PhD (c)

CONTACT

[email protected]

+90 (212) 213 64 86 ext. 203

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No ADT

Other

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.

Primary outcomes

  1. Core Stability

    Time frame: 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.

  2. Modified Star Excursion Balance Test (mSEBT)

    Time frame: 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

  3. 6-Minute Walk Test (6MWT)

    Time frame: 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.

  4. Timed Up and Go Test (TUG)

    Time frame: 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 outcomes

  1. 30-Second Sit-to-Stand Test

    Time frame: Baseline (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.

  2. Fatigue Severity Scale (FSS)

    Time frame: 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.

  3. Fatigue Numeric Rating Scale (NRS-Fatigue)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tahire Basak Demir, PhD (c)

CONTACT

[email protected]

+90 (212) 213 64 86 ext. 203

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Acronym: PEDI-CORE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.