The Effect of Cognitive Exercise on Upper Extremity Functions, Balance and Cognitive Functions in Multiple Sclerosis

NCT ID: NCT06511154

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2025-06-15

Brief Summary

Multiple sclerosis (MS) is a chronic, progressive, demyelinating disease characterized by myelin sheath damage in the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults aged 20-40 years, especially in women. Like physical impairments, cognitive impairments are a common clinical finding in individuals with MS, both in the early and late stages of the disease. Individuals with MS with cognitive impairment have more difficulty than those without cognitive impairment in participating in social and occupational activities, finding a job, working and performing routine household activities. It is also known that there is a high percentage of individuals with MS with upper extremity involvement in the early stages of the disease. Functional problems in the upper extremities lead to restriction of activity and participation in individuals with MS. Although it is stated that there is a high rate of upper extremity problems in individuals with MS, it is seen that they are not sufficiently understood and analyzed.

When the literature is examined; evidence-based studies examining the effect of cognitive exercise on motor functions in MS in addition to physical exercises are quite limited. In this context, the subject of this study is to examine the effect of cognitive rehabilitation on upper extremity functions, balance and cognitive functions in individuals with MS.

Detailed Description

Cognitive rehabilitation is a set of therapeutic approaches that aim to increase functional capacity by examining the relationship between brain and behavior in many areas of cognition such as attention, memory, concentration, reasoning, problem solving, judgment, motor planning and awareness, and the first goal of treatment is to minimize the loss of acquired neuro-cognitive function. Although cognitive rehabilitation programs have been shown to significantly slow down cognitive decline in studies on MS, rehabilitation studies are still in their infancy. In addition, the content and intensity of the rehabilitation program required to provide an effective result have not been clarified. Evidence-based studies examining the effect of cognitive exercise in addition to physical exercise on motor function in MS are also very limited. There are some studies investigating cognitive rehabilitation alone or physical rehabilitation, but to our knowledge, there are no studies investigating the superiority of cognitive rehabilitation over a classical physiotherapy program consisting of core-based upper extremity exercises. Therefore, more original and new studies are needed. Our study is important in this sense. The aim of this study was to show the effect of cognitive rehabilitation on upper extremity functions, balance and cognitive functions when it is applied in addition to physical rehabilitation in order to develop coping strategies by slowing down cognitive losses in individuals with MS and to ensure regeneration if possible. With the findings obtained as a result of the study, it is aimed to increase the quality of life of MS patients by increasing and developing cognitive rehabilitation programs in MS patients.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

Patients in this group are the group in which a physiotherapy program consisting of cognitive rehabilitation and core-based upper extremity exercises will be applied.

Group Type: EXPERIMENTAL

Cognitive Rehabilitation

Intervention Type: OTHER

Cognitive rehabilitation is a treatment method used to regain or improve cognitive abilities.For the cognitive rehabilitation program, the Daily Exercise Package of the Norosoft Program, which mainly includes exercises to improve attention, information processing speed, verbal and visual memory functions, will be applied.

Core-based Upper Extremity Exercises

Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises

Core-based Upper Extremity Exercises

Intervention Type: OTHER

Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises

Control group

Patients in this group are the group in which a physiotherapy program consisting of core-based upper extremity exercises will be applied.

Group Type: ACTIVE_COMPARATOR

Core-based Upper Extremity Exercises

Intervention Type: OTHER

Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises

Interventions

Cognitive Rehabilitation

Cognitive rehabilitation is a treatment method used to regain or improve cognitive abilities.For the cognitive rehabilitation program, the Daily Exercise Package of the Norosoft Program, which mainly includes exercises to improve attention, information processing speed, verbal and visual memory functions, will be applied.

Core-based Upper Extremity Exercises

Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises

Intervention Type: OTHER

Core-based Upper Extremity Exercises

Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises

Intervention Type: OTHER

Other Intervention Names

Core-based Upper Extremity Exercises

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 18 and 65
• A definitive diagnosis of MS by a neurologist
• Having an Expanded Disability Status Scale (EDSS) score below 5.5
• No cognitive problems (Mini Mental Test score of 24 and above),
• Graduated from at least primary school
• No change in medical treatment in the last 6 months,
• Not having had an attack in the last 3 months and not using pulse steroid therapy
• Volunteering.

Exclusion Criteria

• Having hearing and vision problems that prevent communication
• Having a neurological or psychiatric disease other than MS that causes cognitive impairment
• Pregnancy
• Oncological diseases
• Having other vestibular and orthopedic diseases that may affect balance
• Continue with a different exercise therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emine İpek Halatcı, MSc

Role: PRINCIPAL_INVESTIGATOR

Ankara Yildirim Beyazıt University

Locations

Ankara Yıldırım Beyazıt University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Emine İpek Halatcı, MSc

Role: CONTACT

emnepek@gmail.com

05347708416

Facility Contacts

Emine İpek Halatcı

Role: primary

emnepek@gmail.com

05347708416

Other Identifiers

21.03.2024/03-641

Identifier Type: -

Identifier Source: org_study_id