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Multiple SclerosisNCT06845722

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

A study testing Balance training and Cognitive Rehabilitation: in people with Multiple Sclerosis, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Balance training and Cognitive Rehabilitation:
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePakistan
Study dates
1 Oct 2024to 2 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Imran Amjad contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting

  • Jinnah Hospital

    Lahore

    Sabiha Arshad, M.Phill, 03248495979, s.arshad@riphah.edu.pk

    Tayyaba jalal awan, DPT, tayyabajalal10@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Balance training, Cognitive Rehabilitation:
Keywords
balance, cognitive training, executive function, quality of life, multiple sclerosis
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balance trainingOther

    • 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
Study groups in NCT06845722
Study groupRoleWhat they receive
(Balance Training + Cognitive Rehabilitation)ExperimentalGroup A will receive both balance training and cognitive rehabilitation twice a week for 12 weeks and each session will last for 1 hour.
Receives: Other: Balance training; Other: Cognitive Rehabilitation:
(Balance Training)Active comparatorGroup B will receive only balance training twice a week for 12 weeks and each session will last for 1 hour.
Receives: Other: Balance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. I. Montreal Cognitive Assessment for Cognitive Impairment:

    • 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.

    Measured: 12 Weeks

  2. II. Berg Balance Scale for balance assessment:

    • 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

    Measured: 12 Weeks

Secondary outcomes (1)

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

    • 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

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start1 Oct 2024
  3. Primary completion20 Feb 2025 (estimated)
  4. Study completion2 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06845722
Sponsor's protocol ID
REC/RCR & AHS/24/0249
Status last verified
Feb 2025
First submitted
20 Feb 2025
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 Neurol. 2023 Oct;22(10):912-924. doi: 10.1016/S1474-4422(23)00280-6.

    PubMed 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.

    PubMed 33989458

  • 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.

    PubMed 17388952

  • 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.

    PubMed 36216015

  • Marcus R. What Is Multiple Sclerosis? JAMA. 2022 Nov 22;328(20):2078. doi: 10.1001/jama.2022.14236.

    PubMed 36413229

Questions about this trial

What is this clinical trial studying?

A study testing Balance training and Cognitive Rehabilitation: in people with Multiple Sclerosis, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

I. Montreal Cognitive Assessment for Cognitive Impairment: (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06845722, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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