StrokeNCT05550311
Robot-Assisted Rehabilitation in Individuals With Stroke
A study testing Robot-assisted rehabilitation and Conventional rehabilitation in people with Stroke, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-assisted rehabilitation and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Robot-assisted rehabilitation, Conventional rehabilitation
- Keywords
- robot-assisted training, respiratory parameters
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted rehabilitationOther
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 rehabilitationOther
The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.
| Study group | Role | What they receive |
|---|---|---|
| Robot group | Experimental | In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week. Receives: Other: Robot-assisted rehabilitation; Other: Conventional rehabilitation |
| Control Group | Active comparator | Participants in this group will be included in a conventional rehabilitation program Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from Baseline Maximal inspiratory pressure at 6 weeks
Maximal expiratory pressure
Mouth pressure will be assessed to document expiratory muscle strength
Measured: 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.
Measured: Change from Baseline Peak Expiratory Flow Rate at 6 weeks
Secondary outcomes (5)
Peak cough flow
Peak cough flow will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.
Measured: 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.
Measured: Change from Baseline 6 Minutes Walking Test at 6 weeks
Time Up and Go Test
The test evaluates the dynamic balance and mobility.
Measured: 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.
Measured: 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.
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Nov 2022
- Primary completion1 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket AKINCI, Assoc.Prof., Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550311
- Sponsor's protocol ID
- 65-22-10
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be shared during the publication process if the journal will ask.
Publications
Okumus B, Akinci B, Aytutuldu GK, Baran MS. Impact of upper extremity robotic rehabilitation on respiratory parameters, functional capacity and dyspnea in patients with stroke: a randomized controlled study. Neurol Sci. 2025 Mar;46(3):1257-1266. doi: 10.1007/s10072-024-07868-z. Epub 2024 Nov 11.
PubMed 39527236
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05550311
- Acronym / sponsor ID
- 65-22-10
- Conditions
- Stroke
- Keywords
- robot-assisted training, respiratory parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Robot group | Experimental | Other: Robot-assisted rehabilitation, Other: Conventional rehabilitationIn addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week. |
| Control Group | Active comparator | Other: Conventional rehabilitationParticipants in this group will be included in a conventional rehabilitation program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted rehabilitationIn 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 | Robot group |
| Conventional rehabilitationThe conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches. | Other | Control Group, Robot group |
Primary outcome
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.
Maximal inspiratory pressure
Time frame: Change from Baseline Maximal inspiratory pressure at 6 weeks
Mouth pressure will be assessed to document inspiratory muscle strength
Maximal expiratory pressure
Time frame: Change from Baseline Maximal expiratory pressure at 6 weeks
Mouth pressure will be assessed to document expiratory muscle strength
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.
5 secondary outcomes
Peak cough flow
Time frame: Change from Baseline Peak cough flow at 6 weeks
6 Minutes Walking Test
Time frame: Change from Baseline 6 Minutes Walking Test at 6 weeks
Time Up and Go Test
Time frame: Change from Baseline Time Up and Go Test at 6 weeks
Dyspnea-12 Scale
Time frame: Change from Baseline Dyspnea-12 Scale at 6 weeks
Satisfaction survey
Time frame: At 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 39527236Okumus B, Akinci B, Aytutuldu GK, Baran MS. Impact of upper extremity robotic rehabilitation on respiratory parameters, functional capacity and dyspnea in patients with stroke: a randomized controlled study. Neurol Sci. 2025 Mar;46(3):1257-1266. doi: 10.1007/s10072-024-07868-z. Epub 2024 Nov 11.
- Individual participant dataSharing planned: Undecided. The data will be shared during the publication process if the journal will ask.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket AKINCI, Assoc.Prof. study chair
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted rehabilitation and Conventional rehabilitation in people with Stroke, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.