search
Back to results

Kinesthetic Brain Exercise in Hemiplegic Individuals With Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
KB Exercises Program
Conventional Rehabilitation program
Sponsored by
Izmir Democracy University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring STROKE, HEMIPLEGIA, COGNITIVE, DYSFUNCTION, EXERCISE

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being in the 30-60 age range Being in the subacute/chronic period (6 months and above). Having unsupported sitting balance. Having the ability to ambulate with and without support Not having botox application for the lower extremities in the last 6 months Being at least 3 and above according to the Functional Ambulation Scale At least level 3 or higher according to Bruunstrom Lower Extremity Motor Staging. Exclusion Criteria: Having a rheumatological, orthopedic or cardiopulmonary disease that prevents participation in exercises Having secondary diseases (MS, Parkinson's, spinal cord injuries, contractures, and post-fracture deformities, etc.) Having cognitive, visual, and auditory problems that prevent communication Having vestibular system disorders.

Sites / Locations

  • Izmir Democracy UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

KB Exercises plus Conventional Rehabilitation Group

Conventional Rehabilitation Group

Arm Description

While the participants in the study group will continue the conventional rehabilitation program described below for 3 weeks, lasting 45 minutes on average, 5 sessions a week, they will participate in a total of 9 sessions of kinesthetic brain exercises, 3 sessions a week lasting 30 minutes on average. Kinesthetic Brain Exercises Program; The kinesthetic brain exercises program basically consists of 3 phases: warm-up phase, exercise phase and cool-down phase.

Control Group; Conventional Rehabilitation program; strengthening exercises, balance/gait training, Proprioceptive Neuromuscular Facilitation techniques, neuromuscular electrical stimulation.

Outcomes

Primary Outcome Measures

Evaluation of Spasticity
Upper and lower extremity spasticity status will be evaluated according to the modified Ashworth scale. Spasticity score will be calculated by adding upper extremity spasticity scores of fingers, wrist, elbow and shoulder spasticity scores for upper extremity, and spasticity scores for lower extremity by adding toes, ankle, knee and hip spasticity scores. Higher scores indicate high spasticity.
Brunnstrom Motor Staging
The Brunnstrom motor assessment is used to evaluate motor function of the hemiplegic side, upper-lower extremities, and hand. According to Brunnstrom, the healing process consists of 6 stages. While the 1st stage is the flaccid stage without isolated movement, the 6th stage is the isolated voluntary movement stage. Only the lower extremity section will be used in this study.
Functional Ambulation Classification (FAS)
The Functional Ambulation Classification is a widely used ambulation scale that evaluates gait. It is scored between 0 and 5 according to the amount of support the patients receive during walking and consists of 6 categories in total. A score of 0 indicates fully dependent ambulation, while a score of 5 indicates completely independent ambulation.
Activity-Specific Balance Confidence Scale
It is a self-report form that asks people to evaluate their balance performance during 16 activities determined in the home and outdoor environment. The scale consists of 16 different activities and each item is scored between 0-100. A score of 0 indicates no confidence, and a score of 100 indicates full confidence. The total score is obtained by summing each item score and dividing it by the number of items. A score below 50 indicates a low level, a score between 50-80 indicates a moderate level, and a score above 80 indicates a high level of physical activity.
Timed Sit to Stand Test
It is a test used to evaluate lower extremity performance and fall risk in stroke patients. During the test, the patient sits on the arm support chair with her back straight and is asked to get up and sit 5 times in quick succession, with her arms crossed on her chest. The elapsed time is recorded in seconds. The patient who cannot stand up unassisted is allowed to get support from the chair and is noted as such. The test is repeated 3 times and the average time is taken. The discrimination cut-off value of this test in stroke individuals is accepted as 12 seconds. If the test takes 15 seconds or more, it is accepted as a risk of repeated falls in elderly individuals.
Timed Up and Go Test
It is a clinical evaluation test used to evaluate fall risk and dynamic balance in individuals. Patients are asked to sit in an upright position on a chair with an upright back, and with the start command, they are asked to walk 3 meters and return to sit on the chair again. The elapsed time is recorded in seconds. If the patient is walking with an assistive device, he is allowed to walk with an assistive device. The test is repeated 3 times and the average time is recorded. If the test takes more than 14 seconds, it indicates an increased risk of falling in stroke patients.
One Leg Standing Test
The one leg standing test is used to evaluate static balance and postural control. Patients are asked to stand on one leg. The test is finished when the patient touches the ground when he/she stands up or when he/she stands on one leg for 30 seconds. Both legs are repeated 3 times and the average elapsed time is recorded.
Berg Balance Scale
Berg balance scale is used to evaluate postural control and fall risk. Berg balance scale consists of 14 items. Each item is scored from 0-4 by observing the performance of the individual. A score of 0 indicates that the patient could not do the activity, and 4 points indicate that she completed the activity independently. According to the Berg balance scale, the highest score that can be obtained is 56, and a score below 45 indicates the risk of falling. A score of 0-20 indicates balance disorder, an acceptable balance between 21-40, and a good balance of 41-56 points.
Assessment of Fall Risk
This scale consists of 2 sections and 19 risk factors. Major risk factors are given 5 points and minor risk factors are given 1 point. Patients with a score of 5 or more on the scale are considered to have a high risk of falling, and patients with a score of less than 5 are considered to have a low risk of falling.
Stroke-Specific Quality of Life Scale
This scale consists of 12 fields containing 49 items. These areas are; mobility (6 items), energy (3 items), upper extremity function (5 items), work/production (3 items), temperament (5 items), self-care (5 items), social role (5 items), family role ( It consists of 3 items), vision (3 items), language (5 items), thinking (3 items), and personality traits (3 items). Each fields has a maximum score of 5 and higher scores indicate better quality of life.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
September 20, 2023
Sponsor
Izmir Democracy University
search

1. Study Identification

Unique Protocol Identification Number
NCT05992844
Brief Title
Kinesthetic Brain Exercise in Hemiplegic Individuals With Stroke
Official Title
Investigation of the Effect of Kinesthetic Brain Exercise on Fall Risk, Balance and Quality of Life in Hemiplegic Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
March 7, 2024 (Anticipated)
Study Completion Date
May 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Democracy University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The success of conventional physical therapy in the rehabilitation of stroke patients is demonstrated in the light of studies. In this study, the effects of kinesthetic brain exercises, which is a new exercise approach to be applied together with conventional physiotherapy and rehabilitation, on fall risk, balance, and quality of life will be investigated in hemiplegic individuals who have had a stroke. Thus, it is thought that the effectiveness of kinesthetic brain exercises applied together with conventional physiotherapy and rehabilitation will contribute to the literature for the creation of rehabilitation programs.
Detailed Description
Stroke is a clinically defined syndrome characterized by rapidly developing symptoms or signs of cerebral dysfunction with no apparent cause other than vascular causes. Symptoms last more than 24 hours and can lead to death. Findings after stroke; upper and lower extremity motor dysfunctions, spasticity, loss of balance and coordination, walking, swallowing, vision, and communication problems. It has been reported that the disability rate ranges from 13-66% and the disability rate varies between 12-64% due to these functional losses that occur after stroke. In stroke patients, hemiplegic picture occurs depending on the size and location of the damage in the brain. hemiplegia: It is a paralysis that affects the upper and lower extremities of one side of the body. A decrease in muscle strength, loss of sensation and dysfunction occur on the affected side. After stroke, the lower extremities are severely affected in hemiplegic individuals. Instability of ankle and knee joints is seen in hemiplegic lower extremities. However, due to instability, the center of gravity shifts towards the unaffected side, which causes balance and coordination disorders. Balance and coordination disorders in hemiplegic individuals cause poor performance in activities and an increased incidence of falls. Kinesthetic brain exercises: Studies investigating the effects of movement, physical activity and exercises on learning and cognitive development have shown that increased attention span, better focus, better behavioral method, and physical activity that contributes to better learning are supported. Conceptually, brain exercises are expressed by the formula: Physical activity + Brain Activity = Better cognitive function. Neuroplasticity is the basis of kinesthetic brain exercises. In the light of research, it has been found that the brain is in a state of re-activating the activity that cannot be done by using other ways. In rehabilitation sessions, it is aimed to reconstruct these pathways by transforming daily activities into purposeful exercises. According to Dennison, the founder of kinesthetic brain exercises, brain exercises; It is a combination of physical and mental training with a series of physical movements that activate the whole body in turn, improving the neural connections between the two cerebral hemispheres to enhance learning. Kinesthetic brain training consists of twenty-six simple movements combined with deep breathing. Most of these movements are done diagonally. These diagonal movements result in stimulation and integration of different parts of the brain, especially the corpus callosum, which enables faster and more integrated communication between the two hemispheres in the long run. It is claimed that this situation supports the formation of new neural connections between the two hemispheres of the brain. Drabben et al. In their study, they suggest that brain exercises may be considered a useful physical therapy strategy for older adults, as they can have a positive effect on brain functioning. The aim of this study is to investigate the effects of kinesthetic brain exercises on lower extremity coordination and balance in hemiplegic individuals who have had a stroke. Thus, it is thought that the effectiveness of kinesthetic brain exercises applied together with conventional physiotherapy and rehabilitation will contribute to the literature for the creation of rehabilitation programs. Study Hypothesis as follows; Kinesthetic brain exercises have an effect on fall risk, balance and quality of life in hemiplegic individuals who have had a stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
STROKE, HEMIPLEGIA, COGNITIVE, DYSFUNCTION, EXERCISE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CONTROLLED
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KB Exercises plus Conventional Rehabilitation Group
Arm Type
Experimental
Arm Description
While the participants in the study group will continue the conventional rehabilitation program described below for 3 weeks, lasting 45 minutes on average, 5 sessions a week, they will participate in a total of 9 sessions of kinesthetic brain exercises, 3 sessions a week lasting 30 minutes on average. Kinesthetic Brain Exercises Program; The kinesthetic brain exercises program basically consists of 3 phases: warm-up phase, exercise phase and cool-down phase.
Arm Title
Conventional Rehabilitation Group
Arm Type
Other
Arm Description
Control Group; Conventional Rehabilitation program; strengthening exercises, balance/gait training, Proprioceptive Neuromuscular Facilitation techniques, neuromuscular electrical stimulation.
Intervention Type
Other
Intervention Name(s)
KB Exercises Program
Other Intervention Name(s)
KINESTHETIC BRAIN EXERCISES
Intervention Description
Kinesthetic Brain Exercises will carried out for 3 weeks, lasting 45 minutes on average, 5 sessions a week, they will participate in a total of 9 sessions of kinesthetic brain exercises, 3 sessions a week lasting 30 minutes on average. Kinesthetic Brain Exercises Program; The kinesthetic brain exercises program basically consists of 3 phases: warm-up phase, exercise phase and cool-down phase.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation program
Intervention Description
Conventional Rehabilitation program; strengthening exercises, balance/gait training, Proprioceptive Neuromuscular Facilitation techniques, neuromuscular electrical stimulation.
Primary Outcome Measure Information:
Title
Evaluation of Spasticity
Description
Upper and lower extremity spasticity status will be evaluated according to the modified Ashworth scale. Spasticity score will be calculated by adding upper extremity spasticity scores of fingers, wrist, elbow and shoulder spasticity scores for upper extremity, and spasticity scores for lower extremity by adding toes, ankle, knee and hip spasticity scores. Higher scores indicate high spasticity.
Time Frame
Change from Baseline at 3 weeks
Title
Brunnstrom Motor Staging
Description
The Brunnstrom motor assessment is used to evaluate motor function of the hemiplegic side, upper-lower extremities, and hand. According to Brunnstrom, the healing process consists of 6 stages. While the 1st stage is the flaccid stage without isolated movement, the 6th stage is the isolated voluntary movement stage. Only the lower extremity section will be used in this study.
Time Frame
Change from Baseline at 3 weeks
Title
Functional Ambulation Classification (FAS)
Description
The Functional Ambulation Classification is a widely used ambulation scale that evaluates gait. It is scored between 0 and 5 according to the amount of support the patients receive during walking and consists of 6 categories in total. A score of 0 indicates fully dependent ambulation, while a score of 5 indicates completely independent ambulation.
Time Frame
Change from Baseline at 3 weeks
Title
Activity-Specific Balance Confidence Scale
Description
It is a self-report form that asks people to evaluate their balance performance during 16 activities determined in the home and outdoor environment. The scale consists of 16 different activities and each item is scored between 0-100. A score of 0 indicates no confidence, and a score of 100 indicates full confidence. The total score is obtained by summing each item score and dividing it by the number of items. A score below 50 indicates a low level, a score between 50-80 indicates a moderate level, and a score above 80 indicates a high level of physical activity.
Time Frame
Change from Baseline at 3 weeks
Title
Timed Sit to Stand Test
Description
It is a test used to evaluate lower extremity performance and fall risk in stroke patients. During the test, the patient sits on the arm support chair with her back straight and is asked to get up and sit 5 times in quick succession, with her arms crossed on her chest. The elapsed time is recorded in seconds. The patient who cannot stand up unassisted is allowed to get support from the chair and is noted as such. The test is repeated 3 times and the average time is taken. The discrimination cut-off value of this test in stroke individuals is accepted as 12 seconds. If the test takes 15 seconds or more, it is accepted as a risk of repeated falls in elderly individuals.
Time Frame
Change from Baseline at 3 weeks
Title
Timed Up and Go Test
Description
It is a clinical evaluation test used to evaluate fall risk and dynamic balance in individuals. Patients are asked to sit in an upright position on a chair with an upright back, and with the start command, they are asked to walk 3 meters and return to sit on the chair again. The elapsed time is recorded in seconds. If the patient is walking with an assistive device, he is allowed to walk with an assistive device. The test is repeated 3 times and the average time is recorded. If the test takes more than 14 seconds, it indicates an increased risk of falling in stroke patients.
Time Frame
Change from Baseline at 3 weeks
Title
One Leg Standing Test
Description
The one leg standing test is used to evaluate static balance and postural control. Patients are asked to stand on one leg. The test is finished when the patient touches the ground when he/she stands up or when he/she stands on one leg for 30 seconds. Both legs are repeated 3 times and the average elapsed time is recorded.
Time Frame
Change from Baseline at 3 weeks
Title
Berg Balance Scale
Description
Berg balance scale is used to evaluate postural control and fall risk. Berg balance scale consists of 14 items. Each item is scored from 0-4 by observing the performance of the individual. A score of 0 indicates that the patient could not do the activity, and 4 points indicate that she completed the activity independently. According to the Berg balance scale, the highest score that can be obtained is 56, and a score below 45 indicates the risk of falling. A score of 0-20 indicates balance disorder, an acceptable balance between 21-40, and a good balance of 41-56 points.
Time Frame
Change from Baseline at 3 weeks
Title
Assessment of Fall Risk
Description
This scale consists of 2 sections and 19 risk factors. Major risk factors are given 5 points and minor risk factors are given 1 point. Patients with a score of 5 or more on the scale are considered to have a high risk of falling, and patients with a score of less than 5 are considered to have a low risk of falling.
Time Frame
Change from Baseline at 3 weeks
Title
Stroke-Specific Quality of Life Scale
Description
This scale consists of 12 fields containing 49 items. These areas are; mobility (6 items), energy (3 items), upper extremity function (5 items), work/production (3 items), temperament (5 items), self-care (5 items), social role (5 items), family role ( It consists of 3 items), vision (3 items), language (5 items), thinking (3 items), and personality traits (3 items). Each fields has a maximum score of 5 and higher scores indicate better quality of life.
Time Frame
Change from Baseline at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being in the 30-60 age range Being in the subacute/chronic period (6 months and above). Having unsupported sitting balance. Having the ability to ambulate with and without support Not having botox application for the lower extremities in the last 6 months Being at least 3 and above according to the Functional Ambulation Scale At least level 3 or higher according to Bruunstrom Lower Extremity Motor Staging. Exclusion Criteria: Having a rheumatological, orthopedic or cardiopulmonary disease that prevents participation in exercises Having secondary diseases (MS, Parkinson's, spinal cord injuries, contractures, and post-fracture deformities, etc.) Having cognitive, visual, and auditory problems that prevent communication Having vestibular system disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betul Taspinar, Prof. Dr.
Phone
+90 506 680 44 26
Email
ptbetul@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Salih Babaoglu, PT.
Phone
+90 507 637 18 23
Email
fzt.salih.babaoglu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Resorlu, Assoc. Prof.
Organizational Affiliation
Çanakkale 18 March University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ferruh Taspinar, Prof. Dr.
Organizational Affiliation
Izmir Democracy University
Official's Role
Study Chair
Facility Information:
Facility Name
Izmir Democracy University
City
İzmir
ZIP/Postal Code
35290
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betul Taspinar, Prof. Dr.
Phone
+90 5066804426
Email
ptbetul@gmail.com
First Name & Middle Initial & Last Name & Degree
Salih Babaoglı, Pt.
Phone
+90 5076371823
Email
fzt.salih.babaoglu@gmail.com
First Name & Middle Initial & Last Name & Degree
Hatice Resorlu, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Ferruh Taspinar, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kinesthetic Brain Exercise in Hemiplegic Individuals With Stroke

We'll reach out to this number within 24 hrs