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

NCT07654738 | Not Yet Recruiting

• 1 other identifier: 2025/451
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric Demyelinating Diseases; Core Stability; Balance; Fatigue

Outcome Measures

Primary Outcomes (4)

• Core Stability

  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.

  Baseline (single assessment)

• Modified Star Excursion Balance Test (mSEBT)

  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

  Baseline (single assessment)

• 6-Minute Walk Test (6MWT)

  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.

  Baseline (single assessment)

• Timed Up and Go Test (TUG)

  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.

  Baseline (Single Assessment)

Secondary Outcomes (3)

• 30-Second Sit-to-Stand Test

  Baseline (single assessment)

• Fatigue Severity Scale (FSS)

  Baseline (single assessment)

• Fatigue Numeric Rating Scale (NRS-Fatigue)

  Past 24 hours and past 1 week (single assessment)

Study Arms (1)

Group 1: Pediatric Demyelinating Disease Group

Other: No ADT

Interventions

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.

Group 1: Pediatric Demyelinating Disease Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted with pediatric patients diagnosed with demyelinating diseases (Multiple Sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)) who are referred to our center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

Location

Related Publications (10)

• Toussaint-Duyster LC, Wong YYM, Van der Cammen-van Zijp MH, Van Pelt-Gravesteijn D, Catsman-Berrevoets CE, Hintzen RQ, Neuteboom RF. Fatigue and physical functioning in children with multiple sclerosis and acute disseminated encephalomyelitis. Mult Scler. 2018 Jun;24(7):982-990. doi: 10.1177/1352458517706038. Epub 2017 Apr 26.

  PMID: 28445083 BACKGROUND

• Tardieu M, Banwell B, Wolinsky JS, Pohl D, Krupp LB. Consensus definitions for pediatric MS and other demyelinating disorders in childhood. Neurology. 2016 Aug 30;87(9 Suppl 2):S8-S11. doi: 10.1212/WNL.0000000000002877.

  PMID: 27572866 BACKGROUND

• Gulati S, Chakrabarty B, Kumar A, Jain P, Patel H, Saini L. Acquired demyelinating disorders of central nervous system: A pediatric cohort. Ann Indian Acad Neurol. 2015 Sep;18(Suppl 1):S48-55. doi: 10.4103/0972-2327.164829.

  PMID: 26538849 BACKGROUND

• Hertel. J., Miller. S. J., Denegar. C. R. (2000). Intratester and intertester reliability during the star excursion balance tests. Journal of sport rehabilitation, 9-(2), 104-116.

  BACKGROUND

• Gladman D, Nash P, Goto H, Birt JA, Lin CY, Orbai AM, Kvien TK. Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis. RMD Open. 2020 Jan;6(1):e000928. doi: 10.1136/rmdopen-2019-000928.

  PMID: 31958274 BACKGROUND

• Gowda VK, Shetty D, Madivala BV, Benakappa N, Benakappa A. Clinical and Radiological Profiles, Treatment, and Outcome of Pediatric Acquired Demyelinating Disorders of Central Nervous System. J Pediatr Neurosci. 2019 Apr-Jun;14(2):76-81. doi: 10.4103/jpn.JPN_62_18.

  PMID: 31516624 BACKGROUND

• Erden A, Acar Arslan E, Dundar B, Topbas M, Cavlak U. Reliability and validity of Turkish version of pediatric balance scale. Acta Neurol Belg. 2021 Jun;121(3):669-675. doi: 10.1007/s13760-020-01302-9. Epub 2020 Feb 19.

  PMID: 32077065 BACKGROUND

• Al-Hameed, A. A. K. (2022). Spearman's correlation coefficient in statistical analysis. International Journal of Nonlinear Analysis and Applications, 13(1), 3249-3255.

  BACKGROUND

• Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004 Mar;85(3 Suppl 1):S86-92. doi: 10.1053/j.apmr.2003.12.005.

  PMID: 15034861 BACKGROUND

• Absoud M, Cummins C, Chong WK, De Goede C, Foster K, Gunny R, Hemingway C, Jardine P, Kneen R, Likeman M, Lim MJ, Pike M, Sibtain N, Whitehouse WP, Wassmer E. Paediatric UK demyelinating disease longitudinal study (PUDDLS). BMC Pediatr. 2011 Jul 28;11:68. doi: 10.1186/1471-2431-11-68.

  PMID: 21798048 BACKGROUND

Related Links

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MeSH Terms

Conditions

Demyelinating Diseases; Fatigue

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tahire Basak Demir, PhD (c)

CONTACT

+90 (212) 213 64 86; tahirebasakdemir@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (c)

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)