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NCT Number: NCT06845722

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Balance training

Other
  • 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:

Other
  • 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

Primary outcomes

  1. I. Montreal Cognitive Assessment for Cognitive Impairment:

    Time frame: 12 Weeks

    • For Cognitive Impairment: This outcome measurement tool will be used for assessment of cognitive impairment. In patients with multiple sclerosis.MoCA is a screening instrument that evaluates seven cognitive domains on a single page and scores range from 0 to 30. The domains are: visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, 5-minute delayed verbal memory, and orientation.(24) The MoCA scoring suggested a cutoff score of 26, with those scoring 25 or below suspected of having (MCI).(24)MoCA had demonstrated an excellent diagnostic validity of 0.89 (95% CI: 0.83-0.95)(25).The inter-rater reliability or an ICC value of MoCA was 0.96 (95% CI: 0.91-0.98.

  2. II. Berg Balance Scale for balance assessment:

    Time frame: 12 Weeks

    • For Balance assessment: This outcome measurement tool will be used for assessment of Balance in patients with multiple sclerosis. The BBS contains 14 static and dynamic balance activities related to daily life. The BBS tasks progress in challenges: from sitting to standing, standing with narrow base of support, and finally to tandem and single-leg stance. Scoring is on a 5-point ordinal scale with 0 indicating an inability to complete the task and 4 as independent with completing the task.(22).The maximum score of 56 indicates good balance. The scale takes approximately 10 to 20 minutes to complete requiring minimal equipment (chair, stopwatch, ruler, and step) and minimal space.(22)The score of 56 indicates the normal functional balance.(22).The score less than 45 will indicates the higher risk of fall due to impaired balance.(22).The validity of the BBS is (7 = -0.50, P <.001,4 and r = -0.58, P < 005).(26).BBS had strong test-retest reliability (ICC = 0.90).26

Secondary outcomes

  1. III. Short form of SF 36-Item health survey for Quality of life:

    Time frame: 12 Weeks

    • For assessment of Quality of life: A 36-item short-form (SF-36) was constructed to survey health status and quality of life. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey is constructed for self-administration by persons 14 years of age and older, and for administration by a trained therapist as well.(27).The items are categorized, totaled, and converted into a scale ranging from 0 (the worst condition of health) to 100

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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