Cognitive CopingNCT06709222
Robotic Rehabilitation and Dual-Task Exercises in Hemiplegic Patients
A study testing robotic rehabilitation and exercise in people with Cognitive Coping and Hemiplegia, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effectiveness of dual-task exercises combined with robotic rehabilitation applied to post-stroke hemiplegia patients. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Coping, Hemiplegia
- What is being tested?
- robotic rehabilitation and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of post-stroke hemiplegia (hemiplegia onset must be between 3 months and 1 year).
- Age range: 30-60 years.
- Voluntariness to participate in rehabilitation.
- Patients with a motor function loss of 30-70% according to Fugl-Meyer Motor Assessment results.
- Literacy
Who cannot join
- History of active psychiatric disease.
- Severe joint deformities or other neurological diseases.
- Having had a recent stroke during rehabilitation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effectiveness of Dual-Task Exercises Applied in Addition to Robotic Rehabilitation in Hemiplegic Patients: A Randomized Controlled Trial
The aim of this study was to investigate the effectiveness of dual-task exercises combined with robotic rehabilitation applied to post-stroke hemiplegia patients.
Read the detailed description
This research is designed as a randomized controlled experimental study. The study will be conducted on 40 hemiplegic patients. Participants will be randomly divided into two groups. Patients in the exercise group will be subjected to dual-task exercises together with robotic rehabilitation. Patients in the control group will be subjected to only the robotic rehabilitation treatment program. Both groups will be treated with 30-45 minute sessions, 3 days a week for 6 weeks. The exercises will be explained to the patients in detail one-on-one and repeated.
- Conditions
- Cognitive Coping, Hemiplegia
- Being tested
- robotic rehabilitation, exercise
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic rehabilitationOther
robotic rehabilitation
exerciseOther
dual-task exercises
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | the group that received robotic rehabilitation only Receives: Other: robotic rehabilitation |
| exercise | Experimental | group receiving robotic rehabilitation and dual-task exercises Receives: Other: robotic rehabilitation; Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test
Timed up and go test is used for the assessment of falls risk among elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.
Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.
Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
Measured: 14 weeks
Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points)
Subject will complete 3 Montreal Cognitive assessment prior to study over 1 week time. Best score of three is used.
After study is complete subject will also undergo 3 Montreal cognitive assessment over 1 week immediately after study. Again best score is used.
Measured: 14 weeks
Mini-Mental State Examination
Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start13 Dec 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive CopingStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Kübra UZUN, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709222
- Sponsor's protocol ID
- Uskudar17
- Status last verified
- Jul 2025
- First submitted
- 25 Nov 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Lian Y, Chen X, Zhang H, Xu G, Duan H, Xie X, Li Z. Effect of task-oriented training assisted by force feedback hand rehabilitation robot on finger grasping function in stroke patients with hemiplegia: a randomised controlled trial. J Neuroeng Rehabil. 2024 May 14;21(1):77. doi: 10.1186/s12984-024-01372-3.
PubMed 38745227Ye JY, Chen R, Chu H, Lin HC, Liu D, Jen HJ, Banda KJ, Kustanti CY, Chou KR. Dual-task training in older adults with cognitive impairment: A meta-analysis and trial sequential analysis of randomized controlled trials. Int J Nurs Stud. 2024 Jul;155:104776. doi: 10.1016/j.ijnurstu.2024.104776. Epub 2024 Apr 18.
PubMed 38703695Uysal I, Ozden F, Tumturk I, Imerci A. The effectiveness of dual task exercise training on balance, mobility, physical performance, and quality of life in children with cerebral palsy: a single-blind randomized controlled trial. Ir J Med Sci. 2024 Apr;193(2):813-821. doi: 10.1007/s11845-023-03530-3. Epub 2023 Sep 30.
PubMed 37777679
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Dual-Task Exercises Applied in Addition to Robotic Rehabilitation in Hemiplegic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06709222
- Acronym / sponsor ID
- Uskudar17
- Conditions
- Cognitive Coping, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 13 Dec 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 29 Nov 2024 (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 this study was to investigate the effectiveness of dual-task exercises combined with robotic rehabilitation applied to post-stroke hemiplegia patients.
Detailed description
This research is designed as a randomized controlled experimental study. The study will be conducted on 40 hemiplegic patients. Participants will be randomly divided into two groups. Patients in the exercise group will be subjected to dual-task exercises together with robotic rehabilitation. Patients in the control group will be subjected to only the robotic rehabilitation treatment program. Both groups will be treated with 30-45 minute sessions, 3 days a week for 6 weeks. The exercises will be explained to the patients in detail one-on-one and repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: robotic rehabilitationthe group that received robotic rehabilitation only |
| exercise | Experimental | Other: robotic rehabilitation, Other: exercisegroup receiving robotic rehabilitation and dual-task exercises |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of post-stroke hemiplegia (hemiplegia onset must be between 3 months and 1 year).
- Age range: 30-60 years.
- Voluntariness to participate in rehabilitation.
- Patients with a motor function loss of 30-70% according to Fugl-Meyer Motor Assessment results.
- Literacy
Key exclusion criteria (3 listed)
- History of active psychiatric disease.
- Severe joint deformities or other neurological diseases.
- Having had a recent stroke during rehabilitation.
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 |
|---|---|---|
| robotic rehabilitationrobotic rehabilitation | Other | control, exercise |
| exercisedual-task exercises | Other | exercise |
Primary outcome
Timed up and go test
Time frame: 14 weeks
Timed up and go test is used for the assessment of falls risk among elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points)
Time frame: 14 weeks
Subject will complete 3 Montreal Cognitive assessment prior to study over 1 week time. Best score of three is used. After study is complete subject will also undergo 3 Montreal cognitive assessment over 1 week immediately after study. Again best score is used.
Mini-Mental State Examination
Time frame: 14 weeks
Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 38745227Li Y, Lian Y, Chen X, Zhang H, Xu G, Duan H, Xie X, Li Z. Effect of task-oriented training assisted by force feedback hand rehabilitation robot on finger grasping function in stroke patients with hemiplegia: a randomised controlled trial. J Neuroeng Rehabil. 2024 May 14;21(1):77. doi: 10.1186/s12984-024-01372-3.
- Background: PubMed 38703695Ye JY, Chen R, Chu H, Lin HC, Liu D, Jen HJ, Banda KJ, Kustanti CY, Chou KR. Dual-task training in older adults with cognitive impairment: A meta-analysis and trial sequential analysis of randomized controlled trials. Int J Nurs Stud. 2024 Jul;155:104776. doi: 10.1016/j.ijnurstu.2024.104776. Epub 2024 Apr 18.
- Background: PubMed 37777679Uysal I, Ozden F, Tumturk I, Imerci A. The effectiveness of dual task exercise training on balance, mobility, physical performance, and quality of life in children with cerebral palsy: a single-blind randomized controlled trial. Ir J Med Sci. 2024 Apr;193(2):813-821. doi: 10.1007/s11845-023-03530-3. Epub 2023 Sep 30.
- Individual participant dataSharing planned: No
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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.
Kübra UZUN study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic rehabilitation and exercise in people with Cognitive Coping and Hemiplegia, run by Uskudar 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 5 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: opening soon, as of the sponsor's last update on 20 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ömer ŞEVGİN (+905069787535, omer.sevgin@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go test (time frame: 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06709222, which also lists 3 linked publications.
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 Jul 2025.