Clinical trial NCT05550311: Robot-Assisted Rehabilitation in Individuals With Stroke
Official title: The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: robot-assisted training
respiratory parameters
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: Stroke has a high rate of morbidity and mortality worldwide. This disease is the third leading cause of death after ischemic heart disease and cancer. Stroke is also the leading cause of disability in adults. It is known that stroke individuals have not only limb restriction, but also respiratory capacity and exercise capacity. It has been shown in the literature that upper extremity functions are directly related to respiratory capacity. Although it is known that upper extremity training has positive effects on respiratory capacity in stroke individuals, more studies are needed to examine the effects of upper extremity robot-assisted rehabilitation on respiratory capacity. The aim of this study is to examine the effects of upper extremity robot-assisted rehabilitation applied in addition to conventional treatment on respiratory parameters, dyspnea, and functional capacity.

Detailed description: One of the most common complications in stroke patients is pulmonary aspiration and pneumonia, which are associated with respiratory functions being affected. Fluoroscopic examinations of stroke patients showed decreased movement in the diaphragm as well as in other muscles on the affected side. The combination of a decrease in respiratory parameters, weakness in respiratory muscles, and a decrease in diaphragmatic activity can cause dyspnea in individuals even that require minimal effort. The low level of physical activity is accompanied by a decrease in respiratory functions, and the participation of individuals in society decreases. The purpose of stroke rehabilitation is to reduce the complications caused by stroke and to increase the individual's psychological, social, physical, and professional level of independence and functionality to the highest level. Nowadays, stroke rehabilitation can be shaped by a variety of methods. In clinics, robotic rehabilitation is commonly used for stroke patients with the development of the technology. In the literature, studies show the effect of robotic rehabilitation on respiratory parameters, also robot-assisted walking training provides significant improvement in some respiratory parameters and increases aerobic capacity. The aim of this study is to evaluate the effects of upper extremity robot-assisted rehabilitation applied in addition to conventional treatment on respiratory parameters, dyspnea, and functional capacity in individuals with stroke.

Eligibility criteria: Inclusion Criteria :

* Between the ages of 18-65,
* Diagnosed with hemorrhagic or ischemic stroke,
* Having a stroke history of at least 3 months,
* Being 16 and above according to the Mini-Mental State Test,
* Three and above according to the Brunnstrom stage,
* Individuals not included in another rehabilitation program will be included.

Exclusion Criteria:

* Chronic cardiac or pulmonary diseases such as COPD, asthma, interstitial lung disease, and heart failure,
* Using tobacco and tobacco products,
* Severe spasticity to prevent robotic rehabilitation (on Modified Ashworth Scale,
* With skin ulcers,
* Non-union or unstable fracture status,
* Individuals with pressure sores will not be included.

Primary outcomes:
measure: Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio
timeFrame: Change from Baseline Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio at 6 weeks
measure: Maximal inspiratory pressure
timeFrame: Change from Baseline Maximal inspiratory pressure at 6 weeks
measure: Maximal expiratory pressure
timeFrame: Change from Baseline Maximal expiratory pressure at 6 weeks
measure: Peak Expiratory Flow Rate
timeFrame: Change from Baseline Peak Expiratory Flow Rate at 6 weeks
Secondary outcomes:
measure: Peak cough flow
timeFrame: Change from Baseline Peak cough flow at 6 weeks
measure: 6 Minutes Walking Test
timeFrame: Change from Baseline 6 Minutes Walking Test at 6 weeks
measure: Time Up and Go Test
timeFrame: Change from Baseline Time Up and Go Test at 6 weeks
measure: Dyspnea-12 Scale
timeFrame: Change from Baseline Dyspnea-12 Scale at 6 weeks
measure: Satisfaction survey
timeFrame: At 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Buket AKINCI, Assoc.Prof.
role: STUDY_CHAIR
References: