Multiple SclerosisNCT06998147
Postural Control and Psychosocial Measures Associations in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
Trial summary
Balance deficits, gait abnormalities, impaired cognitive function, psychological disturbances and disconnection from community are key characteristics of multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- correlation and regression analyses
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2025to 29 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Predictive Associations Among Postural Balance, Functional Mobility, Cognitive Function and Psychological Well-being in Patients With Multiple Sclerosis: A Cross-Sectional Study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- correlation and regression analyses
- Keywords
- Balance, Cognitive function, Depression, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correlation and regression analysesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: this outcome will take from 7 o 10 days to be completely assessed in all patients
Secondary outcomes (4)
TUG test scores.
Functional mobility will be measured via the well validated Timed Up and Go (TUG) test.
Measured: 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)
Measured: 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
Measured: 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)
Measured: this outcome will take from 5 to 7 days to be completely assessed in all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start18 Mar 2025
- Primary completion25 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mohammed, Cairo University
- Investigators
- Rasha M Hegazy, ph. D, Principal investigator, Assistant professor of Neurology, Department of Physical Therapy for neurology and neurosurgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998147
- Sponsor's protocol ID
- No: H-02-J-002
- Status last verified
- Jul 2025
- First submitted
- 19 May 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Darwesh AAA, Batarfi RM, Abdelmohsen AM, Hegazy RM. "Investigating Predictive Associations Among Postural Balance, Functional Mobility, Cognitive Function and Psychological Well-Being in Patients With Multiple Sclerosis: A Cross-Sectional Study". Physiother Res Int. 2026 Apr;31(2):e70213. doi: 10.1002/pri.70213.
PubMed 41960734
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Predictive Associations Among Postural Balance, Functional Mobility, Cognitive Function and Psychological Well-being in Patients With Multiple Sclerosis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06998147
- Acronym / sponsor ID
- No: H-02-J-002
- Conditions
- Multiple Sclerosis
- Keywords
- Balance, Cognitive function, Depression, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| correlation and regression analysesto 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. | Other | – |
Primary outcome
Berg Balance Scale (BBS) scores
Time frame: 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)
4 secondary outcomes
TUG test scores.
Time frame: this outcome will take from 7 o 10 days to be completely assessed in all patients
Montreal Cognitive Assessment (MoCA) scores
Time frame: this outcome will take from 5 to 7 days to be completely assessed in all patients
HADS scores
Time frame: this outcome will take from 5 to 7 days to be completely assessed in all patients
CIQ scores
Time frame: this outcome will take from 5 to 7 days to be completely assessed in all patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 41960734Darwesh AAA, Batarfi RM, Abdelmohsen AM, Hegazy RM. "Investigating Predictive Associations Among Postural Balance, Functional Mobility, Cognitive Function and Psychological Well-Being in Patients With Multiple Sclerosis: A Cross-Sectional Study". Physiother Res Int. 2026 Apr;31(2):e70213. doi: 10.1002/pri.70213.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasha M Hegazy, ph. D principal investigator
Assistant professor of Neurology, Department of Physical Therapy for neurology and neurosurgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) scores (time frame: this outcome will take from 7 o 10 days to be completely assessed in all patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06998147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.