Robot-Assisted Rehabilitation in Individuals With Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Robot-assisted rehabilitation
Conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring robot-assisted training, respiratory parameters
Eligibility Criteria
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.
Sites / Locations
- Biruni UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot group
Control Group
Arm Description
In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week.
Participants in this group will be included in a conventional rehabilitation program
Outcomes
Primary Outcome Measures
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.
Maximal inspiratory pressure
Mouth pressure will be assessed to document inspiratory muscle strength
Maximal expiratory pressure
Mouth pressure will be assessed to document expiratory muscle strength
Peak Expiratory Flow Rate
Spirometric assessment will be performed to determine participants' peak expiratory flow rate.
Secondary Outcome Measures
Peak cough flow
Peak cough flow will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.
6 Minutes Walking Test
The 6 minutes walk test is a sub-maximal exercises test use to assess aerobic capacity and endurance.
Time Up and Go Test
The test evaluates the dynamic balance and mobility.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05550311
Brief Title
Robot-Assisted Rehabilitation in Individuals With Stroke
Official Title
The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity in Individuals With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
robot-assisted training, respiratory parameters
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
Outcomes Assessor
Masking Description
The assessor will be blind to group allocation.
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot group
Arm Type
Experimental
Arm Description
In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in this group will be included in a conventional rehabilitation program
Intervention Type
Other
Intervention Name(s)
Robot-assisted rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.
Primary Outcome Measure Information:
Title
Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio
Description
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
Title
Maximal inspiratory pressure
Description
Mouth pressure will be assessed to document inspiratory muscle strength
Time Frame
Change from Baseline Maximal inspiratory pressure at 6 weeks
Title
Maximal expiratory pressure
Description
Mouth pressure will be assessed to document expiratory muscle strength
Time Frame
Change from Baseline Maximal expiratory pressure at 6 weeks
Title
Peak Expiratory Flow Rate
Description
Spirometric assessment will be performed to determine participants' peak expiratory flow rate.
Time Frame
Change from Baseline Peak Expiratory Flow Rate at 6 weeks
Secondary Outcome Measure Information:
Title
Peak cough flow
Description
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
Title
6 Minutes Walking Test
Description
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
Title
Time Up and Go Test
Description
The test evaluates the dynamic balance and mobility.
Time Frame
Change from Baseline Time Up and Go Test at 6 weeks
Title
Dyspnea-12 Scale
Description
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
Title
Satisfaction survey
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Buket AKINCI, Assoc.Prof.
Phone
+90 212 409 12 12
Ext
1208
Email
barbuket@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Busra Cucu, PT
Phone
+90 5433274557
Email
busracucu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buket AKINCI, Assoc.Prof.
Organizational Affiliation
Biruni University
Official's Role
Study Chair
Facility Information:
Facility Name
Biruni University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buket AKINCI, Assoc. Prof.
Phone
+90 409 12 12
Ext
1208
Email
barbuket@hotmail.com
First Name & Middle Initial & Last Name & Degree
Busra Cucu, PT
Phone
+90 5433274557
Email
busracucu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data will be shared during the publication process if the journal will ask.
Learn more about this trial
Robot-Assisted Rehabilitation in Individuals With Stroke
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