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NCT Number: NCT05550311

Robot-Assisted Rehabilitation in Individuals With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, 34010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robot-assisted rehabilitation

Other

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.

conventional rehabilitation

Other

The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.

Primary outcomes

  1. 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.

  2. Maximal inspiratory pressure

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

    Mouth pressure will be assessed to document inspiratory muscle strength

  3. Maximal expiratory pressure

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

    Mouth pressure will be assessed to document expiratory muscle strength

  4. 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.

Secondary outcomes

  1. Peak cough flow

    Time frame: 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.

  2. 6 Minutes Walking Test

    Time frame: 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.

  3. Time Up and Go Test

    Time frame: Change from Baseline Time Up and Go Test at 6 weeks

    The test evaluates the dynamic balance and mobility.

  4. Dyspnea-12 Scale

    Time frame: 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.

  5. Satisfaction survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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