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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: October 2022

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.

Interventions

  • Other: Cognitive Rehabilitation
    • Language, memory, attention and executive function exercises are performed for the participants’ deficient cognitive functions.
  • Other: Conventional Therapy
    • Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • Traditional exercises: stretching exercises, strengthening exercises, balance exercises, walking exercises and fine motor skill exercises.
  • Experimental: Cognitive Rehabilitation Group
    • Cognitive rehabilitation; memory, executive function, attention, concentration and calculation exercises.

Clinical Trial Outcome Measures

Primary Measures

  • Montreal Cognitive Assessment
    • Time Frame: a day before the study start
    • 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
    • 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.
  • Fugl-Meyer Assessment
    • Time Frame: a day before the study start
    • The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.
  • 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.
  • Tinetti Balance & Gait Test
    • Time Frame: a day before the study start
    • Tinetti Balance and Gait Scale is used to evaluate patients’ balance and gait.
  • 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.
  • Falls Efficacy Scale International (FES-I)
    • Time Frame: a day before the study start
    • 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)
    • 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 Measures

  • The Timed Up & Go (TUG) Test
    • Time Frame: a day before the study start
    • 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
    • Time Frame: through study completion, an average of 2 months
    • 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
    • Time Frame: a day before the study start
    • 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
    • Time Frame: through study completion, an average of 2 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istanbul University-Cerrahpasa
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rüstem Mustafaoğlu, Associate Professor – Istanbul University-Cerrahpasa
  • Overall Official(s)
    • Rüstem Mustafaoğlu, Study Director, IstanbulUniversity-Cerrahpasa
  • Overall Contact(s)
    • Ömer Faruk Akan, +90 (531) 495 51 38, omerfaruk.akan@ogr.iuc.edu.tr

References

Hoffmann T, Bennett S, Koh CL, McKenna KT. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD006430. doi: 10.1002/14651858.CD006430.pub2. Review. Update in: Cochrane Database Syst Rev. 2022 Mar 29;3:CD006430.

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.

Niemeijer M, Sværke 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.

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.

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