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

August 4, 2022 updated by: Rüstem Mustafaoğlu, Istanbul University - Cerrahpasa (IUC)
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group

Traditional exercises:

stretching exercises, strengthening exercises, balance exercises, walking exercises and fine motor skill exercises.
Other: Conventional Therapy
Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.
Experimental: Cognitive Rehabilitation Group
Cognitive rehabilitation; memory, executive function, attention, concentration and calculation exercises.
Other: Conventional Therapy
Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.
Other: Cognitive Rehabilitation
Language, memory, attention and executive function exercises are performed for the participants' deficient cognitive functions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
a day before the study start
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.
through study completion, an average of 2 months
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.
a day before the study start
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.
through study completion, an average of 2 months
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.
a day before the study start
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.
through study completion, an average of 2 months
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.
a day before the study start
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.
through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
a day before the study start
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.
through study completion, an average of 2 months
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.
a day before the study start
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.
through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Rüstem Mustafaoğlu, İstanbulUniversity-Cerrahpaşa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC-omerfarukakan-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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