Kinesthetic Brain Exercise in Hemiplegic Individuals With Stroke

NCT05992844 | Completed

• 1 other identifier: STROKE-KBE-35
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

STROKE; HEMIPLEGIA; COGNITIVE; DYSFUNCTION; EXERCISE

Outcome Measures

Primary Outcomes (10)

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

• 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.

  Change from Baseline at 3 weeks

Study Arms (2)

KB Exercises plus Conventional Rehabilitation Group

EXPERIMENTAL

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.

Other: KB Exercises Program; Other: Conventional Rehabilitation program

Conventional Rehabilitation Group

OTHER

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

Other: Conventional Rehabilitation program

Interventions

KB Exercises Program OTHER

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.

Also known as: KINESTHETIC BRAIN EXERCISES

KB Exercises plus Conventional Rehabilitation Group

Conventional Rehabilitation program OTHER

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

Conventional Rehabilitation Group; KB Exercises plus Conventional Rehabilitation Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, 35290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Hemiplegia; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Hatice Resorlu, Assoc. Prof.

  Çanakkale 18 March University

  STUDY CHAIR

• Ferruh Taspinar, Prof. Dr.

  Izmir Democracy University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROF. DR.

Model Details: RANDOMIZED CONTROLLED

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 15, 2023
• Study Start: September 4, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 22, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)