Robot-Assisted Rehabilitation in Individuals With Stroke

The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity 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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Robot-assisted rehabilitation; Other: Conventional rehabilitation

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34010
    • Biruni University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot group; 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; 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.; Other: Conventional rehabilitation; The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.
Active Comparator: Control Group; Participants in this group will be included in a conventional rehabilitation program	Other: Conventional rehabilitation; The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Change from Baseline Maximal inspiratory pressure at 6 weeks
Maximal expiratory pressure	Mouth pressure will be assessed to document expiratory muscle strength	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.	Change from Baseline Peak Expiratory Flow Rate at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak cough flow	Peak cough flow will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.	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.	Change from Baseline 6 Minutes Walking Test at 6 weeks
Time Up and Go Test	The test evaluates the dynamic balance and mobility.	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.	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.	At 6 weeks

Collaborators and Investigators

• Sponsor: Biruni University
• Investigators: Study Chair: Buket AKINCI, Assoc.Prof., Biruni University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: respiratory parameters; robot-assisted training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 65-22-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be shared during the publication process if the journal will ask.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No