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Clinical Trials/NCT05490628
NCT05490628
Unknown
Not Applicable

The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients

Istanbul University - Cerrahpasa (IUC)0 sites24 target enrollmentSeptember 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
24
Primary Endpoint
Montreal Cognitive Assessment
Last Updated
3 years ago

Overview

Brief Summary

One of the most common complications in stroke patients is cognitive impairment. Cognitive impairment affects a large part of the life of stroke patients. However, the relationship between cognitive impairment and fear of falling in stroke patients has not been investigated in any study yet. Various treatment approaches have been developed to improve cognitive function. While some of these approaches focus on improving cognitive function, others aim to reach the maximum functional level with various compensation methods taught to the patient in the current cognitive situation. As a result of cognitive interventions, stroke patients' participation in daily life, adherence to treatment and quality of life increase. The aim of this study is to investigate the effects of cognitive interventions on motor performance, balance and fear of falling. This study will contribute to the literature by investigating these effects of cognitive rehabilitation.

Detailed Description

Participants will be randomized into two groups as control and experimental groups. The control group will receive traditional rehabilitation intervention, while the experimental group will receive additional cognitive intervention to traditional rehabilitation. Two groups will be evaluated before and after the study. Participants' motor performance, balance and fear of falling will be determined by evaluation criteria.

Registry
clinicaltrials.gov
Start Date
September 2022
End Date
December 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Rüstem Mustafaoğlu

Associate Professor

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Having been diagnosed with stroke
  • The duration of the disease is in the range of 1-24 months
  • Having a score of 21 or lower on the mini mental state test
  • Having received 3 or more according to the Functional Ambulation Scale
  • Not having a vision problem that will affect the vision of the materials to be used during the treatment
  • Being able to communicate sufficiently to understand the simple orders given

Exclusion Criteria

  • Having been diagnosed with bilateral stroke
  • Having a neurological disease other than the diagnosis of stroke
  • Development of aphasia after stroke

Outcomes

Primary Outcomes

Montreal Cognitive Assessment

Time Frame: through study completion, an average of 2 months

Developed to evaluate mild cognitive impairments, Montreal Cognitive Assessment assesses different cognitive abilities including executive functions, visuospatial skills, memory, language, attention concentration, abstract thinking, calculation and orientation. It takes about 10 minutes to administer and the highest total score that can be obtained from the test is 30. Accordingly, scores of 21 and above are considered normal.

Tinetti Balance & Gait Test

Time Frame: through study completion, an average of 2 months

Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.

Fugl-Meyer Assessment

Time Frame: through study completion, an average of 2 months

The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.

Falls Efficacy Scale International (FES-I)

Time Frame: through study completion, an average of 2 months

FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.

Secondary Outcomes

  • The Timed Up & Go (TUG) Test(through study completion, an average of 2 months)
  • 10 meter walking test(through study completion, an average of 2 months)

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