- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06778525
The Effect of Rehabilitative Games With SmartPose on Upper Extremity Recovery in Stroke Patients
The Effect of Rehabilitative Games With SmartPose Practice on Upper Extremity Recovery in Ischemic Stroke Patients
The goal of this clinical trial is to investigate the effects of SmartPose games on upper extremity motor, functional, and sensory recovery in patients with stroke. The main question it aims to answer is:
- Does the use of rehabilitative games with the SmartPose application work to treat upper extremity motor, functional, and sensory recovery in stroke patients?
Researchers will compare the experimental group with the control group, which receives only conventional exercises with proven effectiveness, to determine whether SmartPose has an effect on upper extremity motor, functional, and sensory recovery in stroke patients.
The experimental group will receive 30 minutes of neuromuscular therapy and 30 minutes of SmartPose, 3 times a week for 8 weeks.
The control group will receive 60 minutes of neuromuscular therapy, 3 times a week for 8 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Istanbul University-Cerrahpaşa, Faculty of Health Science
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mini Mental State Examination score ≥ 24
- Age between 35 and 75 years
- Medical condition sufficiently stable to allow participation in active rehabilitation
- Brunnstrom Upper Extremity Stage ≥ 3
- Minimum sixth week post-stroke
- Ability to perform shoulder abduction and flexion against gravity with a minimum of 20°
Exclusion Criteria:
- Presence of secondary impairments affecting upper extremity movement
- Modified Ashworth Scale score of 4 or 5
- Inability to maintain independent sitting balance
- Visual impairment or loss that prevents the perception of visual materials
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group
A one-hour exercise protocol will be administered in this group, consisting of 30 minutes of conventional exercises and 30 minutes of Smartpose exercises.
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Personalized neuromuscular exercises, according to the patient's specific needs.
Other Names:
Virtual reality application containing rehabilitative games developed for individuals in need of exercise.
Other Names:
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Active Comparator: Control
A one-hour conventional exercise program will be administered to this group.
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Personalized neuromuscular exercises, according to the patient's specific needs.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Limb
Time Frame: Baseline and 8 weeks
|
Fugl-Meyer is the first measure developed to quantitatively assess sensorimotor recovery after stroke.
In our study, to evaluate total sensorimotor recovery, we used the motor function section of this assessment, which consists of 33 items and a total of 66 points, and the sections on sensation, passive joint movement, and joint pain, which have a total of 60 points.
Higher scores reflect better motor function recovery.
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Baseline and 8 weeks
|
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Frenchay Arm Test
Time Frame: Baseline and 8 weeks
|
FAT assesses motor control and hand skills in patients with functional loss in the upper extremity following neurological impairment.
The test consists of 5 items and takes a total of 3 minutes.
Each item is scored as successful (1 point) or unsuccessful (0 points).
It is evaluated on a total of 5 points.
Higher scores reflect better motor control.
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Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale
Time Frame: Baseline and 8 weeks
|
MAS is a scale developed to assess muscle tone by determining the resistance exhibited against passive movement throughout the range of motion in the joint, and its validity has been proven in cases of stroke.
The Modified Ashworth Scale (MAS) consists of six categories: 0, 1, 1+, 2, 3, and 4 (with the addition of 1+).
Scoring is based on the resistance felt during passive movement of the joint, where 0 indicates no increase in muscle tone and 4 indicates a rigid joint.
Lower scores reflect a lower degree of spasticity.
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Baseline and 8 weeks
|
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Brunnstrom Stages of Stroke Recovery
Time Frame: Baseline and 8 weeks
|
Brunnstrom is an approach that can be used both as a treatment approach and to assess body functions in cases of stroke.
The Brunnstrom staging system has created a common language in the rehabilitation process.
Higher stages indicate closer approximation to normal motor function.
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Baseline and 8 weeks
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Box and Block Test
Time Frame: Baseline and 8 weeks
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BBT is a measure that evaluates manual dexterity based on performance.
The patient was asked to move as many cubes as possible from the box in front of them to the other box next to them using the affected extremity for 60 seconds.
A higher number of transferred cubes indicates better hand performance.
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Baseline and 8 weeks
|
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Functional Independence Measure
Time Frame: Baseline and 8 weeks
|
The FIM is used to assess patients' functional status and level of independence.
The test consists of two sections; motor skills and cognitive skills.
Scores range from 18, indicating complete dependence, to 126, indicating full independence.
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Baseline and 8 weeks
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Stroke Specific Quality of Life Scale
Time Frame: Baseline and 8 weeks
|
The Stroke-Specific Quality of Life Scale was developed to assess quality of life parameters in stroke patients.
The scale consists of a total of 48 items and 8 subscales.
The items of the Stroke-Specific Quality of Life Scale are rated on a 5-point scale ranging from 1 to 5. The response options are scored as '1 = strongly agree, 2 = partially agree, 3 = neutral, 4 = partially disagree, and 5 = strongly disagree.'
For some items, the response options are scored as '1 = could not do at all, 2 = had great difficulty, 3 = had some difficulty, 4 = had little difficulty, and 5 = no difficulty.'
Higher total scores indicate better quality of life.
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Baseline and 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Ischemic Stroke
- Stroke
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Aftercare
- Continuity of Patient Care
- Exercise
- Rehabilitation
- Exergaming
Other Study ID Numbers
- Msc thesis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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