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StrokeNCT05490628

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

A study testing Cognitive Rehabilitation and Conventional Therapy in people with Stroke and Cognition Disorder, run by Istanbul University - Cerrahpasa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke, Cognition Disorder, Fear Anxiety
What is being tested?
Cognitive Rehabilitation and Conventional Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Sep 2022to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Having been diagnosed with bilateral stroke
  • Having a neurological disease other than the diagnosis of stroke
  • Development of aphasia after stroke

Trial locations and contacts

No sites are listed yet.

Ömer Faruk Akan contact

+90 (531) 495 51 38

omerfaruk.akan@ogr.iuc.edu.tr

Rüstem Mustafaoğlu, PhD contact

+90 (555) 417 85 35

rustem.mustafaoglu@istanbul.edu.tr

About this study

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.

Read the 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.

Being tested
Cognitive Rehabilitation, Conventional Therapy
Medical subject headings
Stroke, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive RehabilitationOther

    Language, memory, attention and executive function exercises are performed for the participants' deficient cognitive functions.

  • Conventional TherapyOther

    Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.

Study groups in NCT05490628
Study groupRoleWhat they receive
Control GroupActive comparatorTraditional exercises: stretching exercises, strengthening exercises, balance exercises, walking exercises and fine motor skill exercises.
Receives: Other: Conventional Therapy
Cognitive Rehabilitation GroupExperimentalCognitive rehabilitation; memory, executive function, attention, concentration and calculation exercises.
Receives: Other: Cognitive Rehabilitation; Other: Conventional Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: a day before the study start

  2. 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.

    Measured: through study completion, an average of 2 months

  3. Fugl-Meyer Assessment

    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.

    Measured: a day before the study start

  4. Fugl-Meyer Assessment

    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.

    Measured: through study completion, an average of 2 months

  5. Tinetti Balance & Gait Test

    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.

    Measured: a day before the study start

  6. Tinetti Balance & Gait Test

    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.

    Measured: through study completion, an average of 2 months

  7. 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.

    Measured: a day before the study start

  8. 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.

    Measured: through study completion, an average of 2 months

Secondary outcomes (4)

  1. 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.

    Measured: a day before the study start

  2. 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.

    Measured: through study completion, an average of 2 months

  3. 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.

    Measured: a day before the study start

  4. 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.

    Measured: through study completion, an average of 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Care provider
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05490628
Sponsor's protocol ID
IstanbulUC-omerfarukakan-001
Status last verified
Aug 2022
First submitted
6 Jul 2022
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20824849

  • 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.

    PubMed 20813995

  • 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.

    PubMed 32992171

  • 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.

    PubMed 29471428

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Rehabilitation and Conventional Therapy in people with Stroke and Cognition Disorder, run by Istanbul University - Cerrahpasa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ömer Faruk Akan (+90 (531) 495 51 38, omerfaruk.akan@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (time frame: a day before the study start). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05490628, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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