Clinical trial NCT06845722: Combined Effects of Balance and Cognitive Training in Patients With Multiple Sclerosis
Official title: Combined Effects of Balance and Cognitive Training on Executive Functions, Balance and Quality of Life in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: balance
cognitive training
executive function
quality of life
multiple sclerosis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple sclerosis is a potentially disabling disease of the brain and spinal cord involving the central nervous system. Multiple Sclerosis can cause balance and cognitive impairment in patients, affecting overall quality of life. Balance and cognitive training can effectively improve the overall executive function and mobility in patients with multiple sclerosis.

Detailed description: Multiple sclerosis is a potentially disabling disease of the brain and spinal cord involving the central nervous system. Multiple Sclerosis can cause balance and cognitive impairment in patients, affecting overall quality of life. Balance and cognitive training can effectively improve the overall executive function and mobility in patients with multiple sclerosis. Enhancing cognitive abilities and balance skills in MS patients can be accomplished through cognitive rehabilitation that prioritizes processing speed. In MS patients, this kind of intervention can also delay the onset of secondary cognitive deficits. This study aims to investigate the combined effects of balance and cognitive training on executive functions, balance, and quality of life in patients with multiple sclerosis.

The randomized controlled trial will be carried out at multi-settings in Lahore in 10 months after the approval of synopsis. The total 42 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique. Participants will be randomly assigned into 2 groups using computer generated method. Group A and Group B participants both will receive balance training, while Group A participants will also receive cognitive training twice a week for 12 weeks and each session will last for 1 hour. Outcome measure tools will be Montreal cognitive assessment (MOCA) for cognitive assessment, Berg balance scale BBS for balance assessment and SF36 questionnaire for assessment of quality of life. The data will be collected at baseline and post treatment to measure the outcome measures. Data will be analyzed by SPSS version 26. Statistical significance will be set at p=0.05. The normality of data will be checked by using Shapiro-Wilk test. For the between group analysis of parametric data, Independent T test will be used, while for within group analysis Paired T test will be used. Kruskal-Wallis test will be applied for non-parametric data.

Eligibility criteria: Inclusion Criteria:

* Age of the patients should be 40-55 years.(20)
* Gender: both males and females
* Patients with diagnosed multiple sclerosis.
* According to MOCA assessment, patients with scoring 21-25 will be included. (Patients with executive function deficits due to Multiple Sclerosis including relapsing-remitting, primary progressive and secondary progressive MS).(21)
* Patients feel difficulty in Impaired Balance and walking.
* According to the Berg Balance Scale, patients under 21-45 will be included.(22)

Exclusion Criteria:

* Participants with a history of moderate to severe head injury, stroke and seizures will be excluded(23)
* Cognitive impairment due to presence of current or past neurological disorders other than Multiple Sclerosis will be excluded.(23)
* Participants with active major psychiatric illness (such as schizophrenia, bipolar disorder or depressive disorder) will be excluded(23)
* Patients with history of learning disabilities, severe head trauma, alcohol or drug abuse will be excluded(23)

Primary outcomes:
measure: I. Montreal Cognitive Assessment for Cognitive Impairment:
timeFrame: 12 Weeks
measure: II. Berg Balance Scale for balance assessment:
timeFrame: 12 Weeks
Secondary outcomes:
measure: III. Short form of SF 36-Item health survey for Quality of life:
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad M.Phill
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Feinstein A, Amato MP, Brichetto G, Chataway J, Chiaravalloti ND, Cutter G, Dalgas U, DeLuca J, Farrell R, Feys P, Filippi M, Freeman J, Inglese M, Meza C, Motl RW, Rocca MA, Sandroff BM, Salter A; CogEx Research Team. Cognitive rehabilitation and aerobic exercise for cognitive impairment in people with progressive multiple sclerosis (CogEx): a randomised, blinded, sham-controlled trial. Lancet Neurol. 2023 Oct;22(10):912-924. doi: 10.1016/S1474-4422(23)00280-6.
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citation: Marcus R. What Is Multiple Sclerosis? JAMA. 2022 Nov 22;328(20):2078. doi: 10.1001/jama.2022.14236.