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

NCT06845722 | Recruiting

• 1 other identifier: REC/RCR & AHS/24/0249
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. Balance and cognitive training can effectively improve the overall executive function and mobility in patients with multiple sclerosis.

Conditions

Multiple Sclerosis

Keywords

balance; cognitive training; executive function; quality of life; multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• 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.

  12 Weeks

• 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

  12 Weeks

Secondary Outcomes (1)

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

  12 Weeks

Study Arms (2)

(Balance Training + Cognitive Rehabilitation)

EXPERIMENTAL

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; Other: Cognitive Rehabilitation:

(Balance Training)

ACTIVE COMPARATOR

Group B will receive only balance training twice a week for 12 weeks and each session will last for 1 hour.

Other: Balance training

Interventions

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

(Balance Training + Cognitive Rehabilitation); (Balance Training)

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

(Balance Training + Cognitive Rehabilitation)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital

Lahore, Pakistan

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37739574 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 17388952 BACKGROUND

• 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.

  PMID: 36216015 BACKGROUND

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

  PMID: 36413229 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sabiha Arshad M.Phill

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: October 1, 2024
• Primary Completion: February 20, 2025
• Study Completion: May 2, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)