Clinical trial NCT06511154: The Effect of Cognitive Exercise on Upper Extremity Functions, Balance and Cognitive Functions in Multiple Sclerosis
Official title: The Effect of Cognitive Exercise in Addition to Physical Exercise on Upper Extremity Functions, Balance and Cognitive Functions in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cognitive Rehabilitation
LOTCA
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: Gulhane Training and Research Hospital
First posted: 2024-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assingment dual parallel group design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cognitive status
timeFrame: Change from baseline at 8 weeks treatment program after.
measure: Upper extremity
timeFrame: Change from baseline at 8 weeks treatment program after.
Secondary outcomes:
measure: Coordination
timeFrame: Change from baseline at 8 weeks treatment program after.
measure: Balance
timeFrame: Change from baseline at 8 weeks treatment program after.
measure: Fatigue
timeFrame: Change from baseline at 8 weeks treatment program after.
measure: Position Sense
timeFrame: Change from baseline at 8 weeks treatment program after.
Other outcomes:
measure: Disability Status
timeFrame: Change from baseline at 8 weeks treatment program after.
measure: Cognitive Status
timeFrame: Change from baseline at 8 weeks treatment program after.
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Emine İpek Halatcı, MSc
role: PRINCIPAL_INVESTIGATOR
References: