HemiplegiaNCT05869786
The Effect of Virtual Reality-Mediated Rehabilitation in Ischemic Stroke Patients
A study testing Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®), conventional rehabilitation program and Exercise in people with Hemiplegia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation added to the conventional rehabilitation program on upper extremity, quality of life, range of motion and spasticity in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®), conventional rehabilitation program and Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age,
- History of Ischemic Stroke
- Accept to participate in the study,
Who cannot join
- Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurologic deficit,
- Uncontrolled hypertension, diabetes, cardiovascular disease etc.
- Cognitive impairment causing difficulty in executing simple commands
- Epilepsy
- Botulinum toxin application to the upper extremity in the last 6 months
- Change in the medical treatment used for spasticity in the last 6 months
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Virtual Reality-Mediated Rehabilitation on Upper Extremity Functions in Ischemic Stroke Patients
The aim of the study was to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation added to the conventional rehabilitation program on upper extremity, quality of life, range of motion and spasticity in patients with stroke.
Read the detailed description
This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PMR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group). Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (total 450 minutes). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.
Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.
After the intervention, patients will be evaluated in terms of upper extremity functions, quality of life, range of motion and spasticity.
All evaluations will be repeated before, after and 3 months after the intervention. Routine 3-month PMR outpatient clinic control is recommended for patients with stroke. Therefore, no additional hospital visit is requested from the patients due to the study.
- Conditions
- Hemiplegia
- Being tested
- Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®), conventional rehabilitation program, Exercise
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)Device
In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves.
conventional rehabilitation programOther
conventional rehabilitation program
ExerciseBehavioural
Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (450 minutes in total). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day. Receives: Device: Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®); Other: conventional rehabilitation program |
| Control Group | Active comparator | Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. Participants in both groups will receive a conventional rehabilitation program. Receives: Other: conventional rehabilitation program; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer upper extremity scale
This scale is a stroke-specific, performance-based scale and each parameter is scored as 0; unsuccessful, 1; partially successful and 2; completely successful performance. This scale consists of five sections: motor function, balance, sensation, range of motion and pain. The motor function assessment section is scored as 100 points (66 upper extremities and 34 lower extremities), sensation (light touch and position sense) 24 points, balance (6 sitting and 8 standing) 14 points, range of motion 44 points and joint pain 44 points.
Measured: Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention
Secondary outcomes (4)
Functional Independence Measure
Participants' functional status will be assessed by Functional Independence Measure. In this scale, the functional status of patients is evaluated with 18 questions under 6 sub-headings, each question is scored between 1-7. Higher scores indicate better functional status.
Measured: Change from Baseline Functional Independence Measure at 3rd Month After Intervention
Handgrip Strength
The handgrip strength of the participants will be evaluated with a dynamometer.
Measured: Change from Baseline Handgrip Strength at 3rd Month After Intervention
Modified Ashworth Scale
Upper extremity muscle spasticity of the participants will be evaluated with the modified Ashworth Scale. According to this scale, spasticity is evaluated between 0-4. Higher points mean more spasticity.
Measured: Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention
Stroke Impact Scale
The quality of life of the participants will be evaluated with the Stroke Impact Scale.It consists of 8 subsections and 59 questions. Each question is scored by rating the difficulty experienced in the last week on a 5-point scale. The score for each section ranges from 0-100. Higher scores are associated with better quality of life.
Measured: Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PTR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Kivanc Menekseoglu, Istanbul University
- Investigators
- AHmet Kivanc Menekseoglu, MD, Principal investigator, Kanuni Sultan Suleyman Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869786
- Sponsor's protocol ID
- 2023.04.43
- Status last verified
- Feb 2024
- First submitted
- 18 Apr 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Virtual Reality-Mediated Rehabilitation on Upper Extremity Functions in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT05869786
- Acronym / sponsor ID
- 2023.04.43
- Conditions
- Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 22 May 2023 (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 aim of the study was to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation added to the conventional rehabilitation program on upper extremity, quality of life, range of motion and spasticity in patients with stroke.
Detailed description
This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PMR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group). Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (total 450 minutes). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.
Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.
After the intervention, patients will be evaluated in terms of upper extremity functions, quality of life, range of motion and spasticity.
All evaluations will be repeated before, after and 3 months after the intervention. Routine 3-month PMR outpatient clinic control is recommended for patients with stroke. Therefore, no additional hospital visit is requested from the patients due to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PTR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®), Other: conventional rehabilitation programParticipants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (450 minutes in total). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day. |
| Control Group | Active comparator | Other: conventional rehabilitation program, Behavioral: ExerciseParticipants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. Participants in both groups will receive a conventional rehabilitation program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of age,
- History of Ischemic Stroke
- Accept to participate in the study,
Key exclusion criteria (7 listed)
- Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurologic deficit,
- Uncontrolled hypertension, diabetes, cardiovascular disease etc.
- Cognitive impairment causing difficulty in executing simple commands
- Epilepsy
- Botulinum toxin application to the upper extremity in the last 6 months
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 Mediated Upper Extremity Rehabilitation (SensoRehab®)In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. | Device | Virtual Reality Group |
| conventional rehabilitation programconventional rehabilitation program | Other | Control Group, Virtual Reality Group |
| ExerciseParticipants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. | Behavioural | Control Group |
Primary outcome
Fugl-Meyer upper extremity scale
Time frame: Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention
This scale is a stroke-specific, performance-based scale and each parameter is scored as 0; unsuccessful, 1; partially successful and 2; completely successful performance. This scale consists of five sections: motor function, balance, sensation, range of motion and pain. The motor function assessment section is scored as 100 points (66 upper extremities and 34 lower extremities), sensation (light touch and position sense) 24 points, balance (6 sitting and 8 standing) 14 points, range of motion 44 points and joint pain 44 points.
4 secondary outcomes
Functional Independence Measure
Time frame: Change from Baseline Functional Independence Measure at 3rd Month After Intervention
Handgrip Strength
Time frame: Change from Baseline Handgrip Strength at 3rd Month After Intervention
Modified Ashworth Scale
Time frame: Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention
Stroke Impact Scale
Time frame: Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention
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 20 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia
Not yet recruiting
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Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
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Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
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Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
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.
AHmet Kivanc Menekseoglu, MD principal investigator
Kanuni Sultan Suleyman Research and Training Hospital
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 Mediated Upper Extremity Rehabilitation (SensoRehab®), conventional rehabilitation program and Exercise in people with Hemiplegia, run by Istanbul 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 3 inclusion and 7 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 20 Feb 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?
Fugl-Meyer upper extremity scale (time frame: Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention). 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 20 Feb 2024.