Robot-Assisted Rehabilitation in Individuals With Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Conventional rehabilitation; Other: Robot-assisted rehabilitation

• Registration Number: NCT05550311
• Lead Sponsor: Biruni University

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.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Study Start: 2022-11-15
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Conventional rehabilitation	Participants in this group will be included in a conventional rehabilitation program
Robot group	Conventional rehabilitation	In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week.
Robot group	Robot-assisted rehabilitation	In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week.

Primary Outcome Measures

Name	Time	Method
Maximal inspiratory pressure	Change from Baseline Maximal inspiratory pressure at 6 weeks	Mouth pressure will be assessed to document inspiratory muscle strength
Peak Expiratory Flow Rate	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	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	Change from Baseline Maximal expiratory pressure at 6 weeks	Mouth pressure will be assessed to document expiratory muscle strength

Secondary Outcome Measures

Name	Time	Method
Time Up and Go Test	Change from Baseline Time Up and Go Test at 6 weeks	The test evaluates the dynamic balance and mobility.
Satisfaction survey	At 6 weeks	This text is used to assess patients' satisfaction. Evaluation will be scored between c0-5 as a verbal response. 0 = not at all satisfied, 5 = very satisfied.
Peak cough flow	Change from Baseline Peak cough flow at 6 weeks	Peak cough flow will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.
Dyspnea-12 Scale	Change from Baseline Dyspnea-12 Scale at 6 weeks	The dyspnea perception will be measured with this scale. There are 12 descriptor items on this scale ranging none (0), mild (1), moderate (2) or severe (3). It provides an overall score for breahtlessness severity that incorporates seven physical items and five affective items.
6 Minutes Walking Test	Change from Baseline 6 Minutes Walking Test at 6 weeks	The 6 minutes walk test is a sub-maximal exercises test use to assess aerobic capacity and endurance.

Trial Locations

Locations (1)

Biruni University; 🇹🇷 Istanbul, Turkey