Combined Effects of Balance and Cognitive Training in Patients With Multiple Sclerosis
NCT ID: NCT06845722
Last Updated: 2025-02-25
Study Results
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Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2024-10-01
2025-05-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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(Balance Training + Cognitive Rehabilitation)
Group A will receive both balance training and cognitive rehabilitation twice a week for 12 weeks and each session will last for 1 hour.
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. Yet, both groups will execute the same training volume (i.e., number of exercises, number of sets per exercise, and duration per set of exercise).
* Progression during training will be achieved by means of increasing exercise duration (i.e., from 30s over 45s to 60 s), change of stance (i.e., two-legged stance, tandem. stance, one-legged stance) and walking (i.e., forward, backward) condition, manipulation of visual input (e.g., eyes opened vs. closed), and concurrent execution of cognitive
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 notebook), and the techniques for stress management to improve performance and functioning in relation to goals. The group sessions of CR involved some tasks of cognitive training.
* The group sessions will be focused on practicing time-and-place orientation through paper-and pencil tasks provided by a therapist and use of a calendar and personal memory notebook or cellular phone at the start of each session. (30)
* The group sessions also involved matching faces and names and learning memory
(Balance Training)
Group B will receive only balance training twice a week for 12 weeks and each session will last for 1 hour.
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. Yet, both groups will execute the same training volume (i.e., number of exercises, number of sets per exercise, and duration per set of exercise).
* Progression during training will be achieved by means of increasing exercise duration (i.e., from 30s over 45s to 60 s), change of stance (i.e., two-legged stance, tandem. stance, one-legged stance) and walking (i.e., forward, backward) condition, manipulation of visual input (e.g., eyes opened vs. closed), and concurrent execution of cognitive
Interventions
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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. Yet, both groups will execute the same training volume (i.e., number of exercises, number of sets per exercise, and duration per set of exercise).
* Progression during training will be achieved by means of increasing exercise duration (i.e., from 30s over 45s to 60 s), change of stance (i.e., two-legged stance, tandem. stance, one-legged stance) and walking (i.e., forward, backward) condition, manipulation of visual input (e.g., eyes opened vs. closed), and concurrent execution of cognitive
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 notebook), and the techniques for stress management to improve performance and functioning in relation to goals. The group sessions of CR involved some tasks of cognitive training.
* The group sessions will be focused on practicing time-and-place orientation through paper-and pencil tasks provided by a therapist and use of a calendar and personal memory notebook or cellular phone at the start of each session. (30)
* The group sessions also involved matching faces and names and learning memory
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
40 Years
55 Years
ALL
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Sabiha Arshad M.Phill
Role: PRINCIPAL_INVESTIGATOR
Riphah International University
Locations
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Jinnah Hospital
Lahore, , Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Lassmann H, Bruck W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007 Apr;17(2):210-8. doi: 10.1111/j.1750-3639.2007.00064.x.
Graves JS, Krysko KM, Hua LH, Absinta M, Franklin RJM, Segal BM. Ageing and multiple sclerosis. Lancet Neurol. 2023 Jan;22(1):66-77. doi: 10.1016/S1474-4422(22)00184-3. Epub 2022 Oct 7.
Marcus R. What Is Multiple Sclerosis? JAMA. 2022 Nov 22;328(20):2078. doi: 10.1001/jama.2022.14236.
Other Identifiers
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REC/RCR & AHS/24/0249
Identifier Type: -
Identifier Source: org_study_id
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