An observational study in Multiple Sclerosis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Cairo University · Observational
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.
This cross-sectional study will be carried out on sixty-four patients with MS. Balance performance was evaluated by a standardized Berg Balance Scale (BBS). Functional mobility will be measured via the well validated Timed Up and Go (TUG) test. Patients᾽ cognitive functions will be assessed by the Montreal Cognitive Assessment (MoCA), which is a sensitive screening test for the diagnosis of mild cognitive impairment. The psychological well-being will be measured based on the Hospital Anxiety and Depression Scale (HADS), which is widely employed to evaluate mood disturbances in clinical settings. Furthermore, community participation and engagement constraints will be measured with the Community Integration Questionnaire (CIQ) as they clearly capture the extent of functional and social integration into the community.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Participants will be screened for inclusion criteria to guarantee sample homogeneity and clinical applicability. First, all subjects will be diagnosed with MS confirmed by a neurologist according to the revised McDonald criteria. These criteria have the highest sensitivity and specificity and therefore are considered the gold standard in MS diagnosis. Second, participants will be be aged at least 18 years, so as to be able, cognitively and legally, to engage in the study as an informed study volunteer. Third, relapse- and relapse related treatments should be stopped by at least 1 month before the assessment. This is crucial in order to maximize the control of the transient influence of aggravation of the symptoms on patients᾽ cognitive and motor performance. Fourth, individuals will be eligible to participate in the study if they can ambulate, either independently or with the use of assistive device, as the study includes physical performance measures such as balance and gait. Finally, the maximum EDSS-value will be below 6 (moderate disability) to ensure independence of gait without constant support, as this is necessary to ensure comparability of balance and cognitive function.
Exclusion Criteria:
-
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.
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)
Time frame: this outcome will take from 7 o 10 days to be completely assessed in all patients
TUG test scores.
Functional mobility will be measured via the well validated Timed Up and Go (TUG) test.
Time frame: this outcome will take from 7 o 10 days to be completely assessed in all patients
Montreal Cognitive Assessment (MoCA) scores
Patients᾽ cognitive functions will be assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: this outcome will take from 5 to 7 days to be completely assessed in all patients
HADS scores
The psychological well-being will be measured based on the Hospital Anxiety and Depression Scale (HADS). It consists of 14 items, divided into two subscales: 7 items for anxiety
Time frame: this outcome will take from 5 to 7 days to be completely assessed in all patients
CIQ scores
community participation and engagement constraints will be measured maximum total score of 30 points. A score of 26 or above is generally considered indicative of normal cognitive function. Scores between 18 and 25 suggest mild cognitive impairment, while scores from 10 to 17 indicate moderate cognitive impairment. A score below 10 reflects severe cognitive decline. According to MoCA guidelines, one point should be added to the total score for individuals with 12 years of education or less to account for the potential impact of educational background. Community Integration Questionnaire (CIQ)
Time frame: this outcome will take from 5 to 7 days to be completely assessed in all patients
Plan to share: Undecided — undecided
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University