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Clinical Trials/NCT06511154
NCT06511154
Recruiting
Not Applicable

The Effect of Cognitive Exercise in Addition to Physical Exercise on Upper Extremity Functions, Balance and Cognitive Functions in Individuals With Multiple Sclerosis

Ankara Yildirim Beyazıt University1 site in 1 country32 target enrollmentMay 13, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Ankara Yildirim Beyazıt University
Enrollment
32
Locations
1
Primary Endpoint
Cognitive status
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 13, 2024
End Date
June 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ankara Yildirim Beyazıt University
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Cognitive status

Time Frame: Change from baseline at 8 weeks treatment program after.

Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) was developed to assess basic cognitive abilities. It is a standardized method used between 6-70 years of age. This scale consists of 6 main sections and 26 subtests including orientation, visual perception, spatial perception, motor praxis, visual motor organization and thinking ability. It takes approximately 30-45 minutes to administer.

Upper extremity

Time Frame: Change from baseline at 8 weeks treatment program after.

Manual Ability Measure-36: The scale includes 23 items with a wide range of difficulty that measure the functional level of patients. Nine Hole Peg Test: Evaluates unilateral fine motor skills in the upper extremity. It requires the participants to first insert the nine sticks one by one into the nine holes and then remove them as quickly as possible against the clock. Box and Block Test: It is used to measure hand gross skill performance.The patient is asked to transfer the maximum number of blocks, one at a time, from one compartment of a wooden box divided into two compartments to the other within 60 seconds. Jebsen - Taylor Hand Function Test: It is an standardized test used to measure fine and gross motor functions of the hand by simulating daily life activities. It consists of 7 subtests: writing, simulated number spinning, lifting small objects, simulated feeding, stacking, moving large light and heavy objects.

Secondary Outcomes

  • Coordination(Change from baseline at 8 weeks treatment program after.)
  • Balance(Change from baseline at 8 weeks treatment program after.)
  • Fatigue(Change from baseline at 8 weeks treatment program after.)
  • Position Sense(Change from baseline at 8 weeks treatment program after.)

Study Sites (1)

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