The Effects of Telerehabilitation-Based Spinal Stabilization Exercises in Stroke Patients

Stroke Clinical Trial

Official title:

The Effects of Telerehabilitation-Based Spinal Stabilization Exercises on Physical Activity Level and Fatigue in Chronic Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306522
• Other study ID #: KA-21098
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: Ali Naim Ceren
• Phone: +90 554 5662055
• Email: alinaimceren[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stroke is a disease that causes sudden focal neurologic function loss lasting longer than 24 hours due to infarction or hemorrhage in relevant part of the central nervous system. Stroke causes a variety of physiological and psychological symptoms. These symptoms can negatively affect physical activity level and fatigue. Spinal stabilization exercises based on the basic principles of motor learning improves the coordination and endurance of the body muscles by increasing kinesthetic awareness, so this exercise approach can be used to strengthen body stability. The aim of this study is to investigate the effects of telerehabilitation based spinal stabilization exercises on physical activity level and fatigue in community dwelling stroke patients.

Description:

Stroke is defined as a neurological disorder that causes acute focal damage to the Central Nervous System due to a vascular cause. Ischemic stroke and hemorrhagic stroke are the two most fundamental types of stroke. Approximately 80% of patients suffer from ischemic stroke, whereas 20% suffer from hemorrhagic stroke. Ischemic strokes usually develop due to arterial occlusions, rarely cerebral veins or venous sinus occlusions. Hemorrhagic strokes develop as intracerebral or subarachnoid hemorrhages.

It happens as a result of a ruptured aneurysm or a ruptured cerebral artery. The clinical presentation after stroke differs according to the affected artery, underlying etiology, localization and size of the affected area. Motor, sensory and cognitive problems such as paresis, spasticity, gait and balance disorders, sensory and visual problems, fatigue, aphasia, depression, apraxia, agnosia, and amnesia may occur after stroke. These symptoms reduce the quality of life of patients and negatively affect daily living activities. In addition, as a result of all these problems, the physical activity levels of the patients decrease. These post-stroke symptoms reveal the need for rehabilitation in these patients. In the literature, there are many rehabilitation approaches after stroke. The main purpose of these approaches is to improve the functional level of patients and to ensure their independence in activities of daily living at the highest possible level.

Spinal stabilization exercises improve trunk stabilization by increasing the activation of the core muscles that wrap the trunk like a corset. The aim of spinal stabilization exercises is to strengthen core muscles, support the vertebral column, provide optimal posture by increasing kinesthetic awareness, and facilitate movements with breathing. In the literature, it has been shown that spinal stabilization exercises improve balance and gait, reduce fatigue, increase the trunk control of the patients, increase the strength of the core muscles, decrease the fear of falling, improve respiratory functions and have positive effects on activities of daily living in stroke patients.

Telerehabilitation has been one of the important research areas of stroke rehabilitation in recent years. It not only provides a treatment opportunity for patients with limited access to rehabilitation centers, but also provides an opportunity to follow-up the rehabilitation of the patients treated in the rehabilitation center after discharge. Physiotherapists reach patients with telecommunication devices (smartphone, tablet, computer) and provide online rehabilitation services.

In this study, it is aimed to increase trunk stabilization with spinal stabilization exercises. The development of trunk stabilization will reduce the load on both the trunk and the extremities, thus reducing the energy expenditure of the patients while performing their daily living activities. As a result, it is predicted that there may be an increase in the functional activity levels of the patients and a decrease in their fatigue. In the literature, there is no study in which spinal stabilization exercises were applied on the basis of telerehabilitation in stroke patients. In addition, there is no study in the literature investigating the effect of spinal stabilization exercises on the physical activity level of stroke patients. This trial is original in these respects. In this study, the effects of telerehabilitation-based spinal stabilization exercises on physical activity level and fatigue in stroke patients will be investigated.

Method: This study was planned as a mixed-type research design in which quantitative and qualitative research methods were used together to investigate the effects of telerehabilitation-based spinal stabilization exercises on physical activity level and fatigue in chronic stroke patients. In the quantitative evaluations of the study, primarily physical activity level and fatigue; secondarily, functional capacity, trunk involvement and quality of life will be evaluated. In the qualitative phase of the study, interviews will be conducted about the patients' experiences with physical activity and fatigue before and after the exercise program. In addition, after the exercise program, the patients will be interviewed about their experiences with the exercises.

The sample size of the study was calculated using the G*Power 3.1 software, considering the study of Yoon et al. It was determined that a total of 24 patients, 12 for each exercise group, should be taken. However, considering the possible data losses, it is planned to include a total of 30 patients, 15 patients in each group, into the study.

Patients will be placed into groups by block randomization method. Also, this study is planned as a single-blind study. The patients in the study group will be given telerehabilitation-based spinal stabilization exercises. The patients in the control group will be given face-to-face spinal stabilization exercises.

Kadriye Armutlu will make the randomization. Evaluation of the patients will be done by Ayla Fil Balkan (AFB). The treatment programs of the patients will be implemented by Ali Naim Ceren (ANC). AFB will make the evaluations without knowing which group the patients are in. Thus, it will be ensured that the study is single-blind. Also, to avoid bias, the ANC will not be informed of the patients' evaluation results until the study is finished.

A qualitative interview will be conducted first with all patients who meet the inclusion criteria. After the qualitative interview, all patients will be fitted with a smart wristband to determine their physical activity level, and they will be asked to stay on the wristband for 7 days, including while they sleep (except when they take a bath). At the end of these 7 days, the wristband will be taken from the patients and the remaining evaluations will be made. After the evaluations are over, the patients will be directed to the physiotherapist who will implement the exercise program. Before starting the treatment programs, the physiotherapist will explain the activation methods of the transversus abdominus and multifidus muscles to the patients face-to-face for a total of 3 days, every other day. In this direction, the activation of the transversus abdominus muscle, which the patients can easily feel and palpate with their hands, will be taught. At the end of this period, if there are patients who cannot contract the transversus abdominus muscle correctly, these patients will be dropped out of the study. Afterwards, spinal stabilization exercise programs will be started online with the patients in the telerehabilitation group and face-to-face with the patients in the control group. In both groups, the exercise programs will last for 1 hour, 3 days a week, for a total of 6 weeks. Fatigue, functional capacity, trunk control, trunk endurance and quality of life evaluations will be performed on all patients 1 day after the exercise program is completed, and smart wristbands will be placed on the patients after the evaluation. Likewise, it will be required to keep the wristband on for 7 days (except for the time they take a bath), including while sleeping. At the end of these 7 days, the smart wristbands will be taken from the patients and a qualitative interview will be conducted.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged between 50-75 years

• Having an ischemic stroke with anterior circulation involvement

• Getting a score of 24 or higher on the Mini Mental Test

• Ambulation in indoor and outdoor environments with or without a walking aid (walker, cane or tripod)

• At least 1 year has passed since the stroke event

• To have the necessary infrastructure (internet) and equipment (smartphone, tablet or computer) for the telerehabilitation application

• Not participating in any physiotherapy program in the last 6 months

• Volunteering to participate in the study

Exclusion Criteria:

• Having a history of more than one stroke

• Having a known orthopedic, psychiatric or other neurological disease

• Having a history of surgery involving the lower extremities, abdominal region or gait

• Known presence of dementia

• Presence of aphasia and apraxia

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Spinal stabilization exercise
The effects of telerehabilitation based spinal stabilization exercise in chronic stroke patients will be investigated.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Physical Activity Level (the mean of the number of steps)	It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the number of steps taken by the users; The following information will be saved: The number of steps in one day: .........steps (the mean of steps in seven days)	6 weeks
Primary	Assessment of Physical Activity Level (the distance of the patient walks)	It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the distance the patient walk.; The following information will be saved: The distance the patients walks in one day:........meters (the mean of the distance in seven days)	6 weeks
Primary	Assessment of Physical Activity Level (the time the patient sleeps)	It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the time the patient sleeps.; The following information will be saved: The time the patient sleeps in one day:......minutes (the mean of sleep time in seven days)	6 weeks
Primary	Assessment of Physical Activity Level (the calories the patient burns)	It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the calories the patients burn.; The following information will be saved: he burned calories in one day:..........calories (the mean of the burned calories in seven days)	6 weeks
Primary	Fatigue Assessment (physical fatigue)	Fatigue will be assessed with Fatigue Severity Scale (FSS). FSS is a scale with scores ranging from 7 to 63. It includes 9 items. Increase of the score shows severe fatigue.	6 weeks
Primary	Fatigue Assessment (cognitive, physical and psychosocial fatigue)	Fatigue will be assessed with Fatigue Impact Scale (FIS). FIS is a scale with scores ranging from 0 to 160. . It includes 40 items. It has 3 subscales; cognitive fatigue (10 items), physical fatigue (10 items) and psychosocial fatigue (20 items).	6 weeks
Primary	Fatigue Assessment (ambulatory fatigue)	Fatigue will be assessed with linear trend of fatigue. Linear trend of fatigue is calculated from the 6 Minute Walk Test. The formula: ([(-5*D1)+(-3*D2)+(-1*D5)+(1*D4)+(3*D5)+(5*D6)])/70 (D1=1 Distance walked in 1st minute, D2=Distance walked in 2nd minute, D3=Distance walked in 3rd minute, D4= Distance walked in 4th minute, D5= Distance walked in 5th minute, D6= distance walked in 6th minute)	6 weeks
Secondary	Functional Capacity Assessment	Functional capacity will be assessed with 6 Minute Walk Test. The distance the patient walks in 6 minutes will be recorded.	6 weeks
Secondary	Trunk Impairment Assessment	Trunk Impairment will be assessed with Trunk Impairment Scale. It consists of 17 items, 3 items evaluating static sitting balance, 10 items evaluating dynamic sitting balance, and 4 items evaluating coordination. The score obtained from the scale is between 0-23, and a high score is an indicator of good trunk control.	6 weeks
Secondary	Assessment of the Endurance of Core Muscles	The McGill protocol will be applied to assess the endurance of the core muscles. This protocol consists of a combination of 4 tests; modified Biering-Sorenson test, trunk flexor endurance test, right and left lateral bridge (lateral plank) tests. Modified Biering-Sorenson test; evaluates the endurance of trunk extensors.	6 weeks
Secondary	Quality of Life Assessment	Quality of Life will be assessed with Stroke Impact Scale 3.0. This scale includes 59 items in 8 subsections, and is scored on a 5-point Likert scale. Each section is scored from 0 to 100 in itself. 8 subsections of the scale; assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and participation. In addition to these 8 sections, there is a visual analog scale of 0-100 points at the end of the scale that evaluates the perception of recovery after stroke	6 weeks