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

NCT06511154 | Recruiting

• 1 other identifier: 21.03.2024/03-641
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Cognitive Rehabilitation; LOTCA

Outcome Measures

Primary Outcomes (2)

• Cognitive status

  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.

  Change from baseline at 8 weeks treatment program after.

• Upper extremity

  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.

  Change from baseline at 8 weeks treatment program after.

Secondary Outcomes (4)

• 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.

Other Outcomes (2)

• Disability Status

  Change from baseline at 8 weeks treatment program after.

• Cognitive Status

  Change from baseline at 8 weeks treatment program after.

Study Arms (2)

Treatment group

EXPERIMENTAL

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.

Other: Cognitive Rehabilitation; Other: Core-based Upper Extremity Exercises

Control group

ACTIVE COMPARATOR

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

Other: Core-based Upper Extremity Exercises

Interventions

Cognitive Rehabilitation 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

Also known as: Core-based Upper Extremity Exercises

Treatment group

Core-based Upper Extremity Exercises OTHER

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

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead
• Gulhane Training and Research Hospital: collaborator

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

RECRUITING

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

• Emine İpek Halatcı, MSc

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine İpek Halatcı, MSc

CONTACT

05347708416; emnepek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single (outcomes assessor) single (outcomes assessor) the evaulation of the patients will be carried out by a blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assingment dual parallel group design

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 19, 2024
• Study Start: May 13, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 15, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)