- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06128187
The Effect of Dual Task Training on Upper Extremity Functions in Stroke Patients
The Effect of Dual Task Training With Virtual Reality on Upper Extremity Functions and Cognitive Functions in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ramazan öztürk
- Phone Number: +90 539 950 8486
- Email: fzt.ozturk@gmail.com
Study Contact Backup
- Name: Ramazan ozturk
- Phone Number: +90 539 950 8486
- Email: fzt.ozturk@hotmail.com
Study Locations
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-
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Istanbul, Turkey, 34000
- Erenkoy physical therapy and rehabilitation hospital
-
Contact:
- Ramazan öztürk
- Phone Number: +90 539 950 8486
- Email: fzt.ozturk@gmail.com
-
Contact:
- özden E oğul
- Phone Number: +90 5324767913
- Email: oogul@medipol.edu.tr
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Istanbul, Turkey, 34000
- Marmara üniversitesi
-
Contact:
- Ramazan öztürk
- Phone Number: +90 539 950 8486
- Email: fzt.ozturk@gmail.com
-
Contact:
- özden E oğul
- Phone Number: +90 5324757913
- Email: oogul@medipol.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
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.
|
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.
|
Active Comparator: Study Group
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Assessment (FMA-UL)
Time Frame: 18 weeks
|
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
|
18 weeks
|
Barthel index
Time Frame: 18 weeks
|
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.
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18 weeks
|
Stroke Specific Quality Of Life scale (SS-QOL)
Time Frame: 18 weeks
|
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.
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18 weeks
|
Montreal Cognitive Assessment (MoCA)
Time Frame: 18 weeks
|
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.
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18 weeks
|
stroop test
Time Frame: 18 weeks
|
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.
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18 weeks
|
Digit Span Test (DST)
Time Frame: 18 weeks
|
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.
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18 weeks
|
oktem SBST
Time Frame: 18 weeks
|
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.
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18 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ramazan öztürk, Marmara University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/06-69
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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