Combined Effects of Balance and Cognitive Training in Patients With Multiple Sclerosis

Официальное название

Combined Effects of Balance and Cognitive Training on Executive Functions, Balance and Quality of Life in Patients With Multiple Sclerosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Balance training
  * The balance training will be given for 12 weeks (2 sessions/week, 30-35 in each) that included six balance exercises per training session. * After 5-min warm-up program including general (e.g., neck rolls, shoulder circles, side bends, hip circles, marsh in place) and specific (e.g., two-/one-legged stance on unstable devices, forward/backward beam walking). * Two sets per balance exercise will be performed for 30s each with a 60s rest period between sets and a 90 s break between exercises. Ye
• Другое Cognitive Rehabilitation:
  * The cognitive rehabilitation will be given for 12 weeks ( 2 sessions/week,30 min each session). The individual sessions for the CR approach will involve an individualized intervention focusing on a personally meaningful goal (e.g., maintaining attention while flipping cards and finding matching pairs, learning to use a cellular phone, remembering the names of people). * The individual sessions will be consisted of practical strategies and aids, compensation strategies (e.g., using a memory not

Первичные конечные точки

• I. Montreal Cognitive Assessment for Cognitive Impairment: [Срок оценки: 12 Weeks]
• II. Berg Balance Scale for balance assessment: [Срок оценки: 12 Weeks]

Вторичные конечные точки (1)

• III. Short form of SF 36-Item health survey for Quality of life: [Срок оценки: 12 Weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Jinnah Hospital — Lahore

Публикации

• Schedler S, Tenelsen F, Wich L, Muehlbauer T. Effects of balance training on balance performance in youth: role of training difficulty. BMC Sports Sci Med Rehabil. 2020 Nov 23;12(1):71. doi: 10.1186/s13102-020-00218-4. PMID 33292455
• Carson N, Leach L, Murphy KJ. A re-examination of Montreal Cognitive Assessment (MoCA) cutoff scores. Int J Geriatr Psychiatry. 2018 Feb;33(2):379-388. doi: 10.1002/gps.4756. Epub 2017 Jul 21. PMID 28731508
• Gil-Gonzalez I, Martin-Rodriguez A, Conrad R, Perez-San-Gregorio MA. Quality of life in adults with multiple sclerosis: a systematic review. BMJ Open. 2020 Nov 30;10(11):e041249. doi: 10.1136/bmjopen-2020-041249. PMID 33257490
• Azimian M, Yaghoubi Z, Ahmadi Kahjoogh M, Akbarfahimi N, Haghgoo HA, Vahedi M. The Effect of Cognitive Rehabilitation on Balance Skills of Individuals with Multiple Sclerosis. Occup Ther Health Care. 2021 Jan;35(1):93-104. doi: 10.1080/07380577.2021.1871698. Epub 2021 Jan 12. PMID 33433260
• Arntzen EC, Braaten T, Fikke HK, Normann B. Feasibility of a new intervention addressing group-based balance and high-intensity training, physical activity, and employment in individuals with multiple sclerosis: a pilot randomized controlled trial. Front Rehabil Sci. 2024 Jan 8;4:1258737. doi: 10.3389/fresc.2023.1258737. eCollection 2023. PMID 38259873
• Perucca L, Scarano S, Russo G, Robecchi Majnardi A, Caronni A. Fatigue may improve equally after balance and endurance training in multiple sclerosis: a randomised, crossover clinical trial. Front Neurol. 2024 Jan 19;15:1274809. doi: 10.3389/fneur.2024.1274809. eCollection 2024. PMID 38385033
• 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 Ne PMID 37739574
• Henry A, Lannoy S, Chaunu MP, Tourbah A, Montreuil M. Social cognition and executive functioning in multiple sclerosis: A cluster-analytic approach. J Neuropsychol. 2022 Mar;16(1):97-115. doi: 10.1111/jnp.12248. Epub 2021 May 14. PMID 33989458

Идентификаторы

NCT: NCT06845722 · REC/RCR & AHS/24/0249

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗