An interventional study of Robot-assisted rehabilitation and Conventional rehabilitation in Stroke, sponsored by Biruni University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 34 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week.
Other: Robot-assisted rehabilitation · Other: Conventional rehabilitation
Participants in this group will be included in a conventional rehabilitation program
Other: Conventional rehabilitation
In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program. Range of motion exercises will display on the monitor as a game form. There are 4 games available on the computer (airplane game, rabbit shooting game, ball game, and shopping game) and these games can provide exercises for three joints (shoulder, elbow wrist). There are also 3 different levels of resistance apparatus for each joint. People with a full range of motion can do these exercises with resistance. Before starting the rehabilitation, which joint and which movement to do is determined. To the person; After explaining the desired movement and how to play the game shown on the monitor, the exercises are started. The exercises last 45 minutes, during which exercises are performed for the shoulder, elbow, and wrist.
The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.
Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio
Spirometric evaluation will be performed to determine the FEV1/FVC value of the participants.
Time frame: Change from Baseline Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio at 6 weeks
Maximal inspiratory pressure
Mouth pressure will be assessed to document inspiratory muscle strength
Time frame: Change from Baseline Maximal inspiratory pressure at 6 weeks
Maximal expiratory pressure
Mouth pressure will be assessed to document expiratory muscle strength
Time frame: Change from Baseline Maximal expiratory pressure at 6 weeks
Peak Expiratory Flow Rate
Spirometric assessment will be performed to determine participants' peak expiratory flow rate.
Time frame: Change from Baseline Peak Expiratory Flow Rate at 6 weeks
Peak cough flow
Peak cough flow will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.
Time frame: Change from Baseline Peak cough flow at 6 weeks
6 Minutes Walking Test
The 6 minutes walk test is a sub-maximal exercises test use to assess aerobic capacity and endurance.
Time frame: Change from Baseline 6 Minutes Walking Test at 6 weeks
Time Up and Go Test
The test evaluates the dynamic balance and mobility.
Time frame: Change from Baseline Time Up and Go Test at 6 weeks
Dyspnea-12 Scale
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.
Time frame: Change from Baseline Dyspnea-12 Scale at 6 weeks
Satisfaction survey
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.
Time frame: At 6 weeks
Plan to share: Undecided — The data will be shared during the publication process if the journal will ask.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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