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Clinical Trials/NCT05550311
NCT05550311
Completed
Not Applicable

The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity in Individuals With Stroke

Biruni University1 site in 1 country34 target enrollmentNovember 15, 2022
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Biruni University
Enrollment
34
Locations
1
Primary Endpoint
Maximal inspiratory pressure
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
October 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Biruni University
Responsible Party
Principal Investigator
Principal Investigator

Buket AKINCI

Assoc.Prof.

Biruni University

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Maximal inspiratory pressure

Time Frame: Change from Baseline Maximal inspiratory pressure at 6 weeks

Mouth pressure will be assessed to document inspiratory muscle strength

Peak Expiratory Flow Rate

Time Frame: Change from Baseline Peak Expiratory Flow Rate at 6 weeks

Spirometric assessment will be performed to determine participants' peak expiratory flow rate.

Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio

Time Frame: Change from Baseline Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio at 6 weeks

Spirometric evaluation will be performed to determine the FEV1/FVC value of the participants.

Maximal expiratory pressure

Time Frame: Change from Baseline Maximal expiratory pressure at 6 weeks

Mouth pressure will be assessed to document expiratory muscle strength

Secondary Outcomes

  • Peak cough flow(Change from Baseline Peak cough flow at 6 weeks)
  • Dyspnea-12 Scale(Change from Baseline Dyspnea-12 Scale at 6 weeks)
  • 6 Minutes Walking Test(Change from Baseline 6 Minutes Walking Test at 6 weeks)
  • Time Up and Go Test(Change from Baseline Time Up and Go Test at 6 weeks)
  • Satisfaction survey(At 6 weeks)

Study Sites (1)

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