StrokeNCT04033185
To Investigate the Effects of Robotic-assisted Gait Training in Stroke Patients
A study testing virtual reality, robot assisted gait training and conventional treatment in people with Stroke and Cerebrovascular Disorders, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of the study was to investigate the effects of robot-assisted gait training and virtual reality on knee joint position sense in patients with chronic stroke. The secondary objective is to examine the effectiveness of these applications on functional gait and balance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Disorders
- What is being tested?
- virtual reality, robot assisted gait training and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2019to 20 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with stroke by specialist physician,
- 6 months after stroke diagnosis,
- Hemiplegia or hemiparesis due to stroke for the first time,
- Being over 18,
- Being able to walk with auxiliary device or independently,
- Mini Mental test score> 24,
- Functional Ambulation Classification FAC ≥ 2,
- Agree to participate in the study.
Who cannot join
- Acute internal discomfort,
- Botulinum toxin administration during 6 months before treatment or during treatment,
- Presence of a history of previous stroke,
- Having influence on both sides,
- Neglect syndrome,
- Presence of severe spasticity (Modified Ashwort Scale> 2),
- Patients weighing more than 100 kg,
- Patients with femoral lengths greater than 50cm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kozaklı Physical Therapy and Rehabilitation Hospital
Nevşehir, Kozakli, 50600
About this study
Official title: Investigation Of The Effects Of Virtual Reality Application With Robotic Rehabilitation In Patients With Chronic Stroke.
The primary aim of the study was to investigate the effects of robot-assisted gait training and virtual reality on knee joint position sense in patients with chronic stroke. The secondary objective is to examine the effectiveness of these applications on functional gait and balance.
Read the detailed description
Despite widespread prevention programs worldwide and advances in acute and subacute management and treatment protocols, stroke remains one of the most common causes of adult disability, representing a serious global health problem. Sensory motor dysfunction, proprioception deficits and hypertonus may develop in stroke patients depending on the location and severity of the brain damaged areas. Virtual reality application, which has been widely used in recent years, is a three-dimensional, computer-generated technology that gives the patient a sense of reality and allows the patient to interact with it. Virtual reality application can be used as a suitable method for proprioceptive rehabilitation due to its ability to manipulate visual feedback of virtual objects. In recent years, another technological method that has been used in the field of neurorehabilitation is robotic rehabilitation. Robot-assisted gait training, which requires repetitive tasks, can enhance neuroplasticity and motor learning, which focuses on the rearrangement of brain tissue. Both technology-based rehabilitation approaches have been shown to be particularly effective in improving the sense of position in the upper extremity. However, studies investigating the effects of these two applications on lower extremity position sensation seem to be insufficient. We think that both methods will be effective in improving the sense of position.
- Conditions
- Stroke, Cerebrovascular Disorders
- Being tested
- virtual reality, robot assisted gait training, conventional treatment
- Keywords
- joint position sense, stroke, virtual reality, robot assisted gait training
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality, robot assisted gait trainingOther
Also called conventional treatment
study group: 15 sessions virtual reality, robot assisted gait training
conventional treatmentOther
study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | virtual reality, robot-assisted gait training, conventional treatment Receives: Other: virtual reality, robot assisted gait training; Other: conventional treatment |
| control group | Other | conventional treatment Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional ambulation classification (FAC)
FAC is used to assess ambulation ability. It is a valid and reliable scale that evaluates the physical support needed during gait from 6 to 0 points. A high score indicates a good gait and a decrease in score indicates a poor gait.
Measured: Before treatment
Activity-Specific Balance Safety Scale
The level of confidence that the patient feels in daily life activities that require balance skills will be assessed with the Activity-Specific Balance Safety Scale. In this scale, individuals are asked to rate the safety feeling they feel between 0% and 100% when performing 16 activities that require the specified balance skill. A score of 100% indicates that the activity will be performed completely safely, and a score of 0% indicates that the activity is not safe at all.
Measured: change from baseline score at the end of 5 weeks
Modified Ashworth Scale
It is a reliable, valid scale commonly used in the assessment of muscle tone. Resistance to passive motion is graded between 0 and 4. A score of 0 defines normal in muscle tone. the score of 1 defines minimal resistance is felt at the end of the range of motion, the score of 1+ defines resistance is felt in less than half of the range of motion, the score of 2 defines resistance is felt in most of the range of motion, but the affected part is easily moved, the score of 3 defines the resistance along the range of motion of the joint is greater and passive movement is difficult, the score of 4 defines the joint movement of the points is restricted and movement is not revealed.
Measured: Before treatment
Modified Rankin Scale
Modified Rankin Scale will be used to determine the disability level of stroke individuals. The Modified Rankin Scale is a widely used, reliable scale to assess functional status after stroke. In this scale, disability is defined at 7 levels. While 6 points are defined as death, 0 points define completely normal functional status. 0 points indicate no symptoms, 1 point indicates that there is no disability despite symptoms, 2 points indicate mild disability, 3 points moderate disability; 4 points moderate-severe disability; 5 points represent severe disability and 6 points represent death.
Measured: change from baseline score at the end of 5 weeks
Stroke Rehabilitation Movement Assessment Scale- STREAM
STREAM, which is widely used in post-stroke motor evaluation, is a valid and reliable scale. STREAM consists of 2 sections and a total of 30 tests evaluating the functional movements and basic mobility activities of the upper and lower extremities. Limb movements are evaluated with 2 points and mobility activities with 3 points. The highest score is 70. A high score indicates that motor impairment is low, and a decrease in score indicates an increase in motor impairment.
Measured: change from baseline score at the end of 5 weeks
Time up and go test
It is a test where balance and functional mobility are evaluated together.
Measured: change from baseline time at the end of 5 weeks
Mobile Phone-Based Joint Angle Measurement
DrGoniometer is an iPhone based joint goniometer application. With the DrGoniometer, the measurement is achieved by positioning a virtual goniometer that appears on the smartphone screen on a photo from the smartphone camera. The clinician takes a photograph of the extremity, records it, measures the joint angle and observes the value. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.
Measured: change from baseline angle at the end of 5 weeks
Berg Balance Scale
It will be used to evaluate the functional balance. Berg balance scale includes 14 tests, which are graded between 0 and 4 by observing the patient's performance. higher values represent a better equilibrium state. A score of 0-20 indicates an imbalance, a score of 21-40 indicates an acceptable balance, a score of 41-56 indicates a good balance.
Measured: change from baseline score at the end of 5 weeks
goniometric measurement
Proprioception can be defined as the perception of the position and of the movement of various body parts in space. Its role is essential in sensorimotor control for movement acuity, joint stability, coordination, and balance. Its clinical evaluation is commonly based on the assessment of the joint position sense (JPS). Both ROM and JPS measurements require estimating angles through goniometer, scoliometer, laser-pointer, and bubble or digital inclinometer. The goniometer will be used to assess the sense of joint position. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.
Measured: change from baseline angle at the end of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start15 Oct 2019
- Primary completion5 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATOS KIRTEKE, Gazi University
- Investigators
- Arzu Güçlü Gündüz, prof., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033185
- Sponsor's protocol ID
- gazi-ftr-neurological-rehab
- Status last verified
- Feb 2020
- First submitted
- 26 Jun 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effects Of Virtual Reality Application With Robotic Rehabilitation In Patients With Chronic Stroke.
- ClinicalTrials.gov ID
- NCT04033185
- Acronym / sponsor ID
- gazi-ftr-neurological-rehab
- Conditions
- Stroke, Cerebrovascular Disorders
- Keywords
- joint position sense, stroke, virtual reality, robot assisted gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 25 Jul 2019 (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.
The primary aim of the study was to investigate the effects of robot-assisted gait training and virtual reality on knee joint position sense in patients with chronic stroke. The secondary objective is to examine the effectiveness of these applications on functional gait and balance.
Detailed description
Despite widespread prevention programs worldwide and advances in acute and subacute management and treatment protocols, stroke remains one of the most common causes of adult disability, representing a serious global health problem. Sensory motor dysfunction, proprioception deficits and hypertonus may develop in stroke patients depending on the location and severity of the brain damaged areas. Virtual reality application, which has been widely used in recent years, is a three-dimensional, computer-generated technology that gives the patient a sense of reality and allows the patient to interact with it. Virtual reality application can be used as a suitable method for proprioceptive rehabilitation due to its ability to manipulate visual feedback of virtual objects. In recent years, another technological method that has been used in the field of neurorehabilitation is robotic rehabilitation. Robot-assisted gait training, which requires repetitive tasks, can enhance neuroplasticity and motor learning, which focuses on the rearrangement of brain tissue. Both technology-based rehabilitation approaches have been shown to be particularly effective in improving the sense of position in the upper extremity. However, studies investigating the effects of these two applications on lower extremity position sensation seem to be insufficient. We think that both methods will be effective in improving the sense of position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Other: virtual reality, robot assisted gait training, Other: conventional treatmentvirtual reality, robot-assisted gait training, conventional treatment |
| control group | Other | Other: conventional treatmentconventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Having been diagnosed with stroke by specialist physician,
- 6 months after stroke diagnosis,
- Hemiplegia or hemiparesis due to stroke for the first time,
- Being over 18,
- Being able to walk with auxiliary device or independently,
Key exclusion criteria (8 listed)
- Acute internal discomfort,
- Botulinum toxin administration during 6 months before treatment or during treatment,
- Presence of a history of previous stroke,
- Having influence on both sides,
- Neglect syndrome,
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 |
|---|---|---|
| virtual reality, robot assisted gait trainingAlso: conventional treatmentstudy group: 15 sessions virtual reality, robot assisted gait training | Other | study group |
| conventional treatmentstudy group: 15 sessions conventional treatment control group: 30 sessions conventional treatment | Other | control group, study group |
Primary outcome
functional ambulation classification (FAC)
Time frame: Before treatment
FAC is used to assess ambulation ability. It is a valid and reliable scale that evaluates the physical support needed during gait from 6 to 0 points. A high score indicates a good gait and a decrease in score indicates a poor gait.
Activity-Specific Balance Safety Scale
Time frame: change from baseline score at the end of 5 weeks
The level of confidence that the patient feels in daily life activities that require balance skills will be assessed with the Activity-Specific Balance Safety Scale. In this scale, individuals are asked to rate the safety feeling they feel between 0% and 100% when performing 16 activities that require the specified balance skill. A score of 100% indicates that the activity will be performed completely safely, and a score of 0% indicates that the activity is not safe at all.
Modified Ashworth Scale
Time frame: Before treatment
It is a reliable, valid scale commonly used in the assessment of muscle tone. Resistance to passive motion is graded between 0 and 4. A score of 0 defines normal in muscle tone. the score of 1 defines minimal resistance is felt at the end of the range of motion, the score of 1+ defines resistance is felt in less than half of the range of motion, the score of 2 defines resistance is felt in most of the range of motion, but the affected part is easily moved, the score of 3 defines the resistance along the range of motion of the joint is greater and passive movement is difficult, the score of 4 defines the joint movement of the points is restricted and movement is not revealed.
Modified Rankin Scale
Time frame: change from baseline score at the end of 5 weeks
Modified Rankin Scale will be used to determine the disability level of stroke individuals. The Modified Rankin Scale is a widely used, reliable scale to assess functional status after stroke. In this scale, disability is defined at 7 levels. While 6 points are defined as death, 0 points define completely normal functional status. 0 points indicate no symptoms, 1 point indicates that there is no disability despite symptoms, 2 points indicate mild disability, 3 points moderate disability; 4 points moderate-severe disability; 5 points represent severe disability and 6 points represent death.
Stroke Rehabilitation Movement Assessment Scale- STREAM
Time frame: change from baseline score at the end of 5 weeks
STREAM, which is widely used in post-stroke motor evaluation, is a valid and reliable scale. STREAM consists of 2 sections and a total of 30 tests evaluating the functional movements and basic mobility activities of the upper and lower extremities. Limb movements are evaluated with 2 points and mobility activities with 3 points. The highest score is 70. A high score indicates that motor impairment is low, and a decrease in score indicates an increase in motor impairment.
Time up and go test
Time frame: change from baseline time at the end of 5 weeks
It is a test where balance and functional mobility are evaluated together.
Mobile Phone-Based Joint Angle Measurement
Time frame: change from baseline angle at the end of 5 weeks
DrGoniometer is an iPhone based joint goniometer application. With the DrGoniometer, the measurement is achieved by positioning a virtual goniometer that appears on the smartphone screen on a photo from the smartphone camera. The clinician takes a photograph of the extremity, records it, measures the joint angle and observes the value. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.
Berg Balance Scale
Time frame: change from baseline score at the end of 5 weeks
It will be used to evaluate the functional balance. Berg balance scale includes 14 tests, which are graded between 0 and 4 by observing the patient's performance. higher values represent a better equilibrium state. A score of 0-20 indicates an imbalance, a score of 21-40 indicates an acceptable balance, a score of 41-56 indicates a good balance.
goniometric measurement
Time frame: change from baseline angle at the end of 5 weeks
Proprioception can be defined as the perception of the position and of the movement of various body parts in space. Its role is essential in sensorimotor control for movement acuity, joint stability, coordination, and balance. Its clinical evaluation is commonly based on the assessment of the joint position sense (JPS). Both ROM and JPS measurements require estimating angles through goniometer, scoliometer, laser-pointer, and bubble or digital inclinometer. The goniometer will be used to assess the sense of joint position. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.
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 5 Feb 2020.
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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.
Arzu Güçlü Gündüz, prof. study director
Gazi 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 virtual reality, robot assisted gait training and conventional treatment in people with Stroke and Cerebrovascular Disorders, run by Gazi 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 8 inclusion and 8 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 5 Feb 2020. 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?
functional ambulation classification (FAC) (time frame: Before treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.