STROKE REHABİLİTATİONNCT06128187
The Effect of Dual Task Training on Upper Extremity Functions in Stroke Patients
A study testing Study Group in people with STROKE REHABİLİTATİON, run by Muş Alparslan University at 2 sites in Turkey (Türkiye).
Trial summary
Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients. Our aim is to determine the effectiveness of dual-task upper extremity training compared to single-task training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STROKE REHABİLİTATİON
- What is being tested?
- Study Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with hemiplegia for the first time
- Patients aged ≥18 years
- Medically stable
- According to Brunnstrom stages, the upper extremity is at stage 3 and above
- Must have the ability to understand, hear and speak sufficiently to perform treatment with a game console.
- Montreal Cognitive Assessment (MoCA) score ≥ 21
- Patients who are literate
Who cannot join
- Presence of high blood pressure, heart disease, vision problems
- Those with risk of shoulder subluxation and fracture
- Hemiplegic side, with joint movement limitation in the upper extremity Having a history of epileptic seizures
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Erenkoy physical therapy and rehabilitation hospital
Istanbul, 34000
Ramazan öztürk, +90 539 950 8486, fzt.ozturk@gmail.com
özden E oğul, +90 5324767913, oogul@medipol.edu.tr
Marmara üniversitesi
Istanbul, 34000
Ramazan öztürk, +90 539 950 8486, fzt.ozturk@gmail.com
özden E oğul, +90 5324757913, oogul@medipol.edu.tr
About this study
Official title: The Effect of Dual Task Training With Virtual Reality on Upper Extremity Functions and Cognitive Functions in Stroke Patients
Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients. Our aim is to determine the effectiveness of dual-task upper extremity training compared to single-task training.
Read the detailed description
Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients.
Materials and Methods: The study was planned on patients who applied to Erenkoy Physical Therapy and Rehabilitation Hospital and were diagnosed with hemiplegia by a specialist neurologist. Participants who met the inclusion criteria in the study will be divided into two groups as Group 1 = study group and group = 2 control groups by computerized randomization method. For the evaluation of upper extremity functions of the participants whose socio-demographic characteristics were recorded; Fugl Mayer Upper Extremity Assessment Scale, Box and Blocks Test (BBT), Stroop Test and Montreal Cognitive Assessment Scale (MOCA) will be used to evaluate cognitive functions. The Barthel index of daily living activities of the patients and the Stroke-Specific Quality of Life Assessment Scale will be used to evaluate the health-related quality of life. Evaluation of double-task performance will be evaluated by the Box and Blocks Test (BBT) and a cognitive task added to the Xbox 360 Kinect game apps. Participants will be evaluated 4 times before the treatment, after the treatment and at the 1st month and 3rd month after the treatment in order to see the sustainability of the effect of the rehabilitation program.
Patients in both groups will receive a conventional upper extremity rehabilitation program (neurophysiological methods, joint range of motion exercises, strengthening exercises, occupational therapy) and 30 minutes of virtual reality training for 6 weeks, 5 days a week, for 45 minutes daily. Participants in the study group will be given double-task training in addition to stroke rehabilitation and virtual reality training. Dual task training will be performed with the addition of cognitive tasks in addition to virtual reality training.
Cognitive Tasks;
- Attention-oriented, e.g. Counting numbers: Counting numbers backwards three by three from the participant rhythmically,
- For memory, e.g. describing activities of daily living: Describing an event from the participant in detail,
- For executive functions, e.g. Verbal communication: It will be planned in the form of giving the participant a letter from the alphabet and asking for words in certain categories such as plants, animals and countries. As progress is made, the difficulty of the missions will increase.
Xbox 360 Kinect game console will be used for virtual reality treatment. In the treatment, a rehabilitation program will be prepared with games that require complex upper extremity movements such as tennis, golf, darts and boxing to improve upper extremity functions.
We think that dual-task training will increase upper extremity functions and cognitive functions. Due to the lack of dual-task training studies with the upper extremity, we think that our study will contribute to upper extremity rehabilitation protocols and dual-task training literature.
- Conditions
- STROKE REHABİLİTATİON
- Being tested
- Control Group, Study Group
- Keywords
- Stroke, Rehabilitation, Virtual Reality, Upper Extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Participants will receive treatment 5 days a week, 45 minutes a day for 6 weeks. After the traditional rehabilitation program, 30 minutes of virtual reality training will be given.
Study GroupOther
Participants will receive treatment 5 days a week, 45 minutes a day for 6 weeks. After the traditional rehabilitation program, 30 minutes of dual-task training will be given
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants will undergo a conventional upper extremity rehabilitation program for 45 minutes daily, 5 days a week, for 6 weeks. After the conventional rehabilitation program, 30 minutes of virtual reality training for the upper extremity will be applied. Receives: Other: Control Group |
| Study Group | Active comparator | Participants will undergo a conventional upper extremity rehabilitation program for 45 minutes a day, 5 days a week, for 6 weeks. In addition to the conventional rehabilitation program, dual-task training will be provided with a 30-minute virtual reality training program. Cognitive tasks will be given in addition to virtual reality training as dual-task training. Receives: Other: Study Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block test (BTT)
Box and Block test (BBT) was used to measure unilateral gross manual dexterity. This test consists of moving, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60seconds. The patients had number of blocks moved within 60seconds was recorded. The higher number of blocks moved, the higher score you get.
Measured: 18 weeks
Secondary outcomes (7)
Fugl-Meyer Assessment (FMA-UL)
The upper limb score in the Fugl-Meyer Assessment (FMA-UL) was used for primary outcome measure to assess the motor function of both upper extremities in- cluding the shoulder, elbow, forearm, wrist, and hand. The FMA-UL is widely used for comprehensive clinical examination of arm function, and the maximal score of FMA-UL is 66 points
Measured: 18 weeks
Barthel index
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
Measured: 18 weeks
Stroke Specific Quality Of Life scale (SS-QOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Measured: 18 weeks
Montreal Cognitive Assessment (MoCA)
The MoCA test is a simple, in-office tool that can quickly determine if there is any impairment in a person's cognitive function, including their ability to understand, reason, and remember. The MoCA test is based on scores with a maximum score of 30. The MoCA test examines seven domains (aspects) of cognitive function with a total of 11 different exercises and tasks.
Measured: 18 weeks
stroop test
The Stroop test will used to measure cognitive function in the present study. This test simultaneously reflects reaction time (speed aspect) and accuracy. Here, the effect of different performance levels among the subjects was minimized by specifying the reaction time as the number of items performed within a given time. In addition, accuracy will measured using the number of errors made.
Measured: 18 weeks
Digit Span Test (DST)
Digit Span Test (DST) is a widely-used neuropsychological test in the assessment of attention and working memory, which consists two sections, forward and backward span.
Measured: 18 weeks
oktem SBST
Oktem (SBST) Test is a test that analyzes verbal learning and memory capacity. Information is collected about the participant's instant memory and ability to sustain attention.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STROKE REHABİLİTATİONStudies of the same condition, open and under way.
- 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
- Two groups. Study group and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Öztürk, Marmara University
- Investigators
- Ramazan öztürk, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128187
- Sponsor's protocol ID
- 2023/06-69
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual Task Training With Virtual Reality on Upper Extremity Functions and Cognitive Functions in Stroke Patients
- ClinicalTrials.gov ID
- NCT06128187
- Acronym / sponsor ID
- 2023/06-69
- Conditions
- STROKE REHABİLİTATİON
- Keywords
- Stroke, Rehabilitation, Virtual Reality, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 13 Nov 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.
Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients. Our aim is to determine the effectiveness of dual-task upper extremity training compared to single-task training.
Detailed description
Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients.
Materials and Methods: The study was planned on patients who applied to Erenkoy Physical Therapy and Rehabilitation Hospital and were diagnosed with hemiplegia by a specialist neurologist. Participants who met the inclusion criteria in the study will be divided into two groups as Group 1 = study group and group = 2 control groups by computerized randomization method. For the evaluation of upper extremity functions of the participants whose socio-demographic characteristics were recorded; Fugl Mayer Upper Extremity Assessment Scale, Box and Blocks Test (BBT), Stroop Test and Montreal Cognitive Assessment Scale (MOCA) will be used to evaluate cognitive functions. The Barthel index of daily living activities of the patients and the Stroke-Specific Quality of Life Assessment Scale will be used to evaluate the health-related quality of life. Evaluation of double-task performance will be evaluated by the Box and Blocks Test (BBT) and a cognitive task added to the Xbox 360 Kinect game apps. Participants will be evaluated 4 times before the treatment, after the treatment and at the 1st month and 3rd month after the treatment in order to see the sustainability of the effect of the rehabilitation program.
Patients in both groups will receive a conventional upper extremity rehabilitation program (neurophysiological methods, joint range of motion exercises, strengthening exercises, occupational therapy) and 30 minutes of virtual reality training for 6 weeks, 5 days a week, for 45 minutes daily. Participants in the study group will be given double-task training in addition to stroke rehabilitation and virtual reality training. Dual task training will be performed with the addition of cognitive tasks in addition to virtual reality training.
Cognitive Tasks;
- Attention-oriented, e.g. Counting numbers: Counting numbers backwards three by three from the participant rhythmically,
- For memory, e.g. describing activities of daily living: Describing an event from the participant in detail,
- For executive functions, e.g. Verbal communication: It will be planned in the form of giving the participant a letter from the alphabet and asking for words in certain categories such as plants, animals and countries. As progress is made, the difficulty of the missions will increase.
Xbox 360 Kinect game console will be used for virtual reality treatment. In the treatment, a rehabilitation program will be prepared with games that require complex upper extremity movements such as tennis, golf, darts and boxing to improve upper extremity functions.
We think that dual-task training will increase upper extremity functions and cognitive functions. Due to the lack of dual-task training studies with the upper extremity, we think that our study will contribute to upper extremity rehabilitation protocols and dual-task training literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups. Study group and control group
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupParticipants will undergo a conventional upper extremity rehabilitation program for 45 minutes daily, 5 days a week, for 6 weeks. After the conventional rehabilitation program, 30 minutes of virtual reality training for the upper extremity will be applied. |
| Study Group | Active comparator | Other: Study GroupParticipants will undergo a conventional upper extremity rehabilitation program for 45 minutes a day, 5 days a week, for 6 weeks. In addition to the conventional rehabilitation program, dual-task training will be provided with a 30-minute virtual reality training program. Cognitive tasks will be given in addition to virtual reality training as dual-task training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are diagnosed with hemiplegia for the first time
- Patients aged ≥18 years
- Medically stable
- According to Brunnstrom stages, the upper extremity is at stage 3 and above
- Must have the ability to understand, hear and speak sufficiently to perform treatment with a game console.
Key exclusion criteria (3 listed)
- Presence of high blood pressure, heart disease, vision problems
- Those with risk of shoulder subluxation and fracture
- Hemiplegic side, with joint movement limitation in the upper extremity Having a history of epileptic seizures
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 |
|---|---|---|
| Control GroupParticipants will receive treatment 5 days a week, 45 minutes a day for 6 weeks. After the traditional rehabilitation program, 30 minutes of virtual reality training will be given. | Other | Control Group |
| Study GroupParticipants will receive treatment 5 days a week, 45 minutes a day for 6 weeks. After the traditional rehabilitation program, 30 minutes of dual-task training will be given | Other | Study Group |
Primary outcome
Box and Block test (BTT)
Time frame: 18 weeks
Box and Block test (BBT) was used to measure unilateral gross manual dexterity. This test consists of moving, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60seconds. The patients had number of blocks moved within 60seconds was recorded. The higher number of blocks moved, the higher score you get.
7 secondary outcomes
Fugl-Meyer Assessment (FMA-UL)
Time frame: 18 weeks
Barthel index
Time frame: 18 weeks
Stroke Specific Quality Of Life scale (SS-QOL)
Time frame: 18 weeks
Montreal Cognitive Assessment (MoCA)
Time frame: 18 weeks
stroop test
Time frame: 18 weeks
Digit Span Test (DST)
Time frame: 18 weeks
oktem SBST
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
Ramazan öztürk study director
Marmara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group in people with STROKE REHABİLİTATİON, run by Muş Alparslan University at 2 sites 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramazan ozturk (+90 539 950 8486, fzt.ozturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block test (BTT) (time frame: 18 weeks). 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 13 Nov 2023.