Multiple Sclerosis
Conditions
Keywords
Balance, Cognitive function, Depression, Multiple Sclerosis
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.
Detailed description
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.
Interventions
OTHERcorrelation and regression analyses
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.
Sponsors
Cairo University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Inclusion criteria
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
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Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) scores | this outcome will take from 7 o 10 days to be completely assessed in all patients | Balance performance was evaluated by a standardized Berg Balance Scale (BBS). scores ranges from 0 (no balance) to 54 (maximum balance) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TUG test scores. | this outcome will take from 7 o 10 days to be completely assessed in all patients | Functional mobility will be measured via the well validated Timed Up and Go (TUG) test. |
| Montreal Cognitive Assessment (MoCA) scores | this outcome will take from 5 to 7 days to be completely assessed in all patients | Patients᾽ cognitive functions will be assessed by the Montreal Cognitive Assessment (MoCA) |
| HADS scores | this outcome will take from 5 to 7 days to be completely assessed in all patients | 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 |
| CIQ scores | this outcome will take from 5 to 7 days to be completely assessed in all patients | 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) |
Countries
Egypt
Outcome results
None listed