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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05490628
• Other study ID #: IstanbulUC-omerfarukakan-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Istanbul University-Cerrahpasa
• Contact: Ömer Faruk Akan
• Phone: +90 (531) 495 51 38
• Email: omerfaruk.akan[@]ogr.iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorder
• Cognition Disorders
• Fear Anxiety
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

References & Publications (4)

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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	a day before the study start
Primary	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.	through study completion, an average of 2 months
Primary	Fugl-Meyer Assessment	The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.	a day before the study start
Primary	Fugl-Meyer Assessment	The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.	through study completion, an average of 2 months
Primary	Tinetti Balance & Gait Test	Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.	a day before the study start
Primary	Tinetti Balance & Gait Test	Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.	through study completion, an average of 2 months
Primary	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.	a day before the study start
Primary	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.	through study completion, an average of 2 months
Secondary	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.	a day before the study start
Secondary	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.	through study completion, an average of 2 months
Secondary	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.	a day before the study start
Secondary	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.	through study completion, an average of 2 months