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

February 20, 2025 updated by: Riphah International University

Combined Effects of Balance and Cognitive Training on Executive Functions, Balance and Quality of Life 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (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.
Other: 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
Other: 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
Active Comparator: (Balance Training)
Group B will receive only balance training twice a week for 12 weeks and each session will last for 1 hour.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks
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
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad M.Phill, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

February 20, 2025

Study Completion (Estimated)

May 2, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/24/0249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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