Postural Control and Psychosocial Measures Associations in Multiple Sclerosis

NCT06998147 | Completed

• 1 other identifier: No: H-02-J-002
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Balance deficits, gait abnormalities, impaired cognitive function, psychological disturbances and disconnection from community are key characteristics of multiple sclerosis (MS). Thus, exploring the interrelationships and the primary risk factors related to clinical manifestations and consequences of MS is of definite clinical significance. The primary aims of the study are to evaluate the association interplay among balance, functional mobility, cognitive function, psychological well-being, and community participation in addition to identify the anticipated contributing factors that function as predictors of MS features.

Conditions

Multiple Sclerosis

Keywords

Balance; Cognitive function; Depression; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS) scores

  Balance performance was evaluated by a standardized Berg Balance Scale (BBS). scores ranges from 0 (no balance) to 54 (maximum balance)

  this outcome will take from 7 o 10 days to be completely assessed in all patients

Secondary Outcomes (4)

• TUG test scores.

  this outcome will take from 7 o 10 days to be completely assessed in all patients

• Montreal Cognitive Assessment (MoCA) scores

  this outcome will take from 5 to 7 days to be completely assessed in all patients

• HADS scores

  this outcome will take from 5 to 7 days to be completely assessed in all patients

• CIQ scores

  this outcome will take from 5 to 7 days to be completely assessed in all patients

Interventions

correlation and regression analyses OTHER

to evaluate the association interplay among balance, functional mobility, cognitive function, psychological well-being, and community participation in addition to identify the anticipated contributing factors that function as predictors of MS features.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Sixty-four patients with MS will be recruited from the King Fahad General Hospital, a governmental hospital in Jeddah, Saudi Arabia. Full demographic data will be gathered and all subjects were carefully examined clinically. The study was ethically approved by the Institutional Review Board (IRB) of the Ministry of Health (MoH), Saudi Arabia (Approval No: H-02-J-002). A written informed consent of agreement to participate in the study will be obtained from all participants before enrollment and after being informed in detail about the purposes, study procedures, and their rights as research participants, in agreement with the ethical principles of the Declaration of Helsinki.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis; Depression

Interventions

Regression Analysis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rasha M Hegazy, ph. D

  Assistant professor of Neurology, Department of Physical Therapy for neurology and neurosurgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 31, 2025
• Study Start: March 18, 2025
• Primary Completion: April 25, 2025
• Study Completion: April 29, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

EG (1)