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NCT Number: NCT04075968

The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS

The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis. We assume that cognitive therapy is an effective treatment for multiple sclerosis.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Istanbul, 34500, Turkey (Türkiye)

About this study

The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with an Mini Mental State Test score less than 24
  • Patients with an Extended Disability Status Scale score less than 4
  • Patients trained for at least 5 years
  • Patients who have not received steroid therapy in the last 1 month

Exclusion criteria

  • Patients who have not passed at least 3 months from the last Multiple Sclerosis attack
  • Patients with hearing and vision problems that may interfere with communication
  • The patients who Have other neurological and psychiatric disorder that will cause cognitive impairment
  • Patients receiving medical treatment for spasticity, tremor, bladder disorder and fatigue

Treatment and study plan

Cognitive exercise

Other

Cognitive exercise will be applied

Home exercise

Other

Home exercise will be applied

Primary outcomes

  1. Neuro-psychometric Test (NPT)

    Time frame: 1 hour

    It is a test that evaluates memory, working memory, planning, organization, attendance span.Evaluation is made according to the number of items filled. The higher number items filled indicates the better status

  2. Berg Balance Scale

    Time frame: 15 minutes

    It is a scale which consists of 14 items. Each item is scored on a five-point scale (0-4).The maximum score for this assessment is 56 and the minimum score for this assessment is 0. Scores below 45 indicate balance impairment. The higher point indicates the better status

  3. Mini Mental State Test (MMST)

    Time frame: 10-15 minutes

    It is a test that evaluates different subset of cognitive status including attention, memory, language, orientation, visuospatial proficiency. It is scored on a scale of 0-30 with scores. Scores above 25 are interpreted as normal cognitive status.

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: 3 minutes

    The MAS is a 6-point rating scale which assesses muscle tone by manually manipulating the joint through its available range of motion and clinically recording the resistance to passive movements. The lower point indicates the better status

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Cognitive Group Exercise Combined With Physical Exercise in Multiple Sclerosis Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 3, 2019
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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