Stroke, IschemicNCT06778525
The Effect of Rehabilitative Games With SmartPose on Upper Extremity Recovery in Stroke Patients
A study testing Exercise and SmartPose in people with Stroke, Ischemic and Smartpose, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Ischemic, Smartpose, Telerehabilitation
- What is being tested?
- Exercise and SmartPose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2025to 1 Jun 2025
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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°
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Faculty of Health Science
Istanbul
About this study
Official title: 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?
Read more
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.
- Conditions
- Stroke, Ischemic, Smartpose, Telerehabilitation
- Being tested
- Exercise, SmartPose
- Keywords
- Rehabilitation, Stroke, Exergaming, Upper Extremity
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Rehabilitation
Personalized neuromuscular exercises, according to the patient's specific needs.
SmartPoseOther
Also called Exergame, Virtual Reality
Virtual reality application containing rehabilitative games developed for individuals in need of exercise.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | A one-hour exercise protocol will be administered in this group, consisting of 30 minutes of conventional exercises and 30 minutes of Smartpose exercises. Receives: Other: Exercise; Other: SmartPose |
| Control | Active comparator | A one-hour conventional exercise program will be administered to this group. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Limb
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.
Measured: Baseline and 8 weeks
Frenchay Arm Test
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.
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Modified Ashworth Scale
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.
Measured: Baseline and 8 weeks
Brunnstrom Stages of Stroke Recovery
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.
Measured: Baseline and 8 weeks
Box and Block Test
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.
Measured: Baseline and 8 weeks
Functional Independence Measure
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.
Measured: Baseline and 8 weeks
Stroke Specific Quality of Life Scale
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start11 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cilen Tavsanoglu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778525
- Sponsor's protocol ID
- Msc thesis
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rehabilitative Games With SmartPose Practice on Upper Extremity Recovery in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT06778525
- Acronym / sponsor ID
- Msc thesis
- Conditions
- Stroke, Ischemic, Smartpose, Telerehabilitation
- Keywords
- Rehabilitation, Stroke, Exergaming, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 11 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 16 Jan 2025 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Exercise, Other: SmartPoseA one-hour exercise protocol will be administered in this group, consisting of 30 minutes of conventional exercises and 30 minutes of Smartpose exercises. |
| Control | Active comparator | Other: ExerciseA one-hour conventional exercise program will be administered to this group. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| ExerciseAlso: RehabilitationPersonalized neuromuscular exercises, according to the patient's specific needs. | Other | Control, Experimental Group |
| SmartPoseAlso: Exergame, Virtual RealityVirtual reality application containing rehabilitative games developed for individuals in need of exercise. | Other | Experimental Group |
Primary outcome
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.
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.
5 secondary outcomes
Modified Ashworth Scale
Time frame: Baseline and 8 weeks
Brunnstrom Stages of Stroke Recovery
Time frame: Baseline and 8 weeks
Box and Block Test
Time frame: Baseline and 8 weeks
Functional Independence Measure
Time frame: Baseline and 8 weeks
Stroke Specific Quality of Life Scale
Time frame: Baseline and 8 weeks
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 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and SmartPose in people with Stroke, Ischemic and Smartpose, run by Istanbul University - Cerrahpasa 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 6 inclusion and 4 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 22 Jan 2026. 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?
The Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Limb (time frame: Baseline and 8 weeks). The study lists 2 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 22 Jan 2026.