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
About this trial
This is an interventional treatment trial for Stroke
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
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
NCT ID
NCT05490628
First Posted
July 6, 2022
Last Updated
August 4, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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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