The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients
1 other identifier
interventional
24
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Sep 2022
Shorter than P25 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 5, 2022
August 1, 2022
1 month
July 6, 2022
August 4, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
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
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
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
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
Tinetti Balance & Gait Test
Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.
a day before the study start
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
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
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 Outcomes (4)
The Timed Up & Go (TUG) Test
a day before the study start
The Timed Up & Go (TUG) Test
through study completion, an average of 2 months
10 meter walking test
a day before the study start
10 meter walking test
through study completion, an average of 2 months
Study Arms (2)
Control Group
ACTIVE COMPARATORTraditional exercises: stretching exercises, strengthening exercises, balance exercises, walking exercises and fine motor skill exercises.
Cognitive Rehabilitation Group
EXPERIMENTALCognitive rehabilitation; memory, executive function, attention, concentration and calculation exercises.
Interventions
Language, memory, attention and executive function exercises are performed for the participants' deficient cognitive functions.
Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Having been diagnosed with bilateral stroke
- Having a neurological disease other than the diagnosis of stroke
- Development of aphasia after stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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;2010(9):CD006430. doi: 10.1002/14651858.CD006430.pub2.
PMID: 20824849BACKGROUNDMiller 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.
PMID: 20813995BACKGROUNDNiemeijer 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.
PMID: 32992171BACKGROUNDLiu 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.
PMID: 29471428BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rüstem Mustafaoğlu
IstanbulUniversity-Cerrahpasa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 6, 2022
First Posted
August 5, 2022
Study Start
September 1, 2022
Primary Completion
October 1, 2022
Study Completion
December 1, 2022
Last Updated
August 5, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share