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

Primary Purpose

Stroke, Cognition Disorder, Fear Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Rehabilitation
Conventional Therapy
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control Group

    Cognitive Rehabilitation Group

    Arm Description

    Traditional exercises: stretching exercises, strengthening exercises, balance exercises, walking exercises and fine motor skill exercises.

    Cognitive rehabilitation; memory, executive function, attention, concentration and calculation exercises.

    Outcomes

    Primary Outcome Measures

    Montreal Cognitive Assessment
    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.
    Montreal Cognitive Assessment
    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.
    Fugl-Meyer Assessment
    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.
    Fugl-Meyer Assessment
    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.
    Tinetti Balance & Gait Test
    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.
    Tinetti Balance & Gait Test
    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.
    Falls Efficacy Scale International (FES-I)
    FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.
    Falls Efficacy Scale International (FES-I)
    FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.

    Secondary Outcome Measures

    The Timed Up & Go (TUG) Test
    TUG is a practical clinical assessment tool developed to measure the physical mobility and motor performance of elderly individuals. TUG measures the time for the person to stand up from the chair, walk 3 meters, and return to the chair and sit.
    The Timed Up & Go (TUG) Test
    TUG is a practical clinical assessment tool developed to measure the physical mobility and motor performance of elderly individuals. TUG measures the time for the person to stand up from the chair, walk 3 meters, and return to the chair and sit.
    10 meter walking test
    10-meter walking test is a practical clinical assessment tool developed to measure walking capacity and motor performance of elderly individuals. The 10-meter walking test is performed by measuring the time it takes for a person to walk at normal walking speed between two markers that are 10 meters apart.
    10 meter walking test
    10-meter walking test is a practical clinical assessment tool developed to measure walking capacity and motor performance of elderly individuals. The 10-meter walking test is performed by measuring the time it takes for a person to walk at normal walking speed between two markers that are 10 meters apart.

    Full Information

    First Posted
    July 6, 2022
    Last Updated
    August 4, 2022
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05490628
    Brief Title
    The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients
    Official Title
    The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Cognition Disorder, Fear Anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly divided into intervention and control groups. Both groups will be treated for 6 weeks. Each participant will be treated for a total of thirty hours, one hour a day, five days a week.
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Traditional exercises: stretching exercises, strengthening exercises, balance exercises, walking exercises and fine motor skill exercises.
    Arm Title
    Cognitive Rehabilitation Group
    Arm Type
    Experimental
    Arm Description
    Cognitive rehabilitation; memory, executive function, attention, concentration and calculation exercises.
    Intervention Type
    Other
    Intervention Name(s)
    Cognitive Rehabilitation
    Intervention Description
    Language, memory, attention and executive function exercises are performed for the participants' deficient cognitive functions.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Therapy
    Intervention Description
    Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.
    Primary Outcome Measure Information:
    Title
    Montreal Cognitive Assessment
    Description
    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.
    Time Frame
    a day before the study start
    Title
    Montreal Cognitive Assessment
    Description
    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.
    Time Frame
    through study completion, an average of 2 months
    Title
    Fugl-Meyer Assessment
    Description
    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.
    Time Frame
    a day before the study start
    Title
    Fugl-Meyer Assessment
    Description
    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.
    Time Frame
    through study completion, an average of 2 months
    Title
    Tinetti Balance & Gait Test
    Description
    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.
    Time Frame
    a day before the study start
    Title
    Tinetti Balance & Gait Test
    Description
    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.
    Time Frame
    through study completion, an average of 2 months
    Title
    Falls Efficacy Scale International (FES-I)
    Description
    FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.
    Time Frame
    a day before the study start
    Title
    Falls Efficacy Scale International (FES-I)
    Description
    FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.
    Time Frame
    through study completion, an average of 2 months
    Secondary Outcome Measure Information:
    Title
    The Timed Up & Go (TUG) Test
    Description
    TUG is a practical clinical assessment tool developed to measure the physical mobility and motor performance of elderly individuals. TUG measures the time for the person to stand up from the chair, walk 3 meters, and return to the chair and sit.
    Time Frame
    a day before the study start
    Title
    The Timed Up & Go (TUG) Test
    Description
    TUG is a practical clinical assessment tool developed to measure the physical mobility and motor performance of elderly individuals. TUG measures the time for the person to stand up from the chair, walk 3 meters, and return to the chair and sit.
    Time Frame
    through study completion, an average of 2 months
    Title
    10 meter walking test
    Description
    10-meter walking test is a practical clinical assessment tool developed to measure walking capacity and motor performance of elderly individuals. The 10-meter walking test is performed by measuring the time it takes for a person to walk at normal walking speed between two markers that are 10 meters apart.
    Time Frame
    a day before the study start
    Title
    10 meter walking test
    Description
    10-meter walking test is a practical clinical assessment tool developed to measure walking capacity and motor performance of elderly individuals. The 10-meter walking test is performed by measuring the time it takes for a person to walk at normal walking speed between two markers that are 10 meters apart.
    Time Frame
    through study completion, an average of 2 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ömer Faruk Akan
    Phone
    +90 (531) 495 51 38
    Email
    omerfaruk.akan@ogr.iuc.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rüstem Mustafaoğlu, PhD
    Phone
    +90 (555) 417 85 35
    Email
    rustem.mustafaoglu@istanbul.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rüstem Mustafaoğlu
    Organizational Affiliation
    IstanbulUniversity-Cerrahpasa
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20824849
    Citation
    Hoffmann T, Bennett S, Koh CL, McKenna KT. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD006430. doi: 10.1002/14651858.CD006430.pub2.
    Results Reference
    background
    PubMed Identifier
    20813995
    Citation
    Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
    Results Reference
    background
    PubMed Identifier
    32992171
    Citation
    Niemeijer M, Svaerke KW, Christensen HK. The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. J Stroke Cerebrovasc Dis. 2020 Dec;29(12):105265. doi: 10.1016/j.jstrokecerebrovasdis.2020.105265. Epub 2020 Sep 11.
    Results Reference
    background
    PubMed Identifier
    29471428
    Citation
    Liu TW, Ng GYF, Chung RCK, Ng SSM. Cognitive behavioural therapy for fear of falling and balance among older people: a systematic review and meta-analysis. Age Ageing. 2018 Jul 1;47(4):520-527. doi: 10.1093/ageing/afy010.
    Results Reference
    background

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

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