Clinical trial NCT05490628: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Cognition Disorder
Fear Anxiety
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: a day before the study start
measure: Montreal Cognitive Assessment
timeFrame: through study completion, an average of 2 months
measure: Fugl-Meyer Assessment
timeFrame: a day before the study start
measure: Fugl-Meyer Assessment
timeFrame: through study completion, an average of 2 months
measure: Tinetti Balance & Gait Test
timeFrame: a day before the study start
measure: Tinetti Balance & Gait Test
timeFrame: through study completion, an average of 2 months
measure: Falls Efficacy Scale International (FES-I)
timeFrame: a day before the study start
measure: Falls Efficacy Scale International (FES-I)
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: The Timed Up & Go (TUG) Test
timeFrame: a day before the study start
measure: The Timed Up & Go (TUG) Test
timeFrame: through study completion, an average of 2 months
measure: 10 meter walking test
timeFrame: a day before the study start
measure: 10 meter walking test
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
Study officials:
affiliation: IstanbulUniversity-Cerrahpasa
name: Rüstem Mustafaoğlu
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.