StrokeNCT06938477
Thera-Trainer Exercise Effects on Motor and Cognitive Outcomes in Stroke: RCT
A study testing THERA-TRAINER BASED EXERCISES and FUNCTIONAL STROKE TRAİNİNG in people with Stroke, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
Technology-supported training supports the rehabilitation process by providing high-intensity, repetitive, and task-specific treatment, contributes to the recovery process, and facilitates the restoration of arm function (Bertani et al., 2017). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- THERA-TRAINER BASED EXERCISES and FUNCTIONAL STROKE TRAİNİNG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2024to 15 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having had an ischemic or hemorrhagic stroke for the first time
- Those with a Montreal Cognitive Assessment (MOCA) score above 21,
- Individuals with a functional level below 4 according to the modified Rankin scale (MRS),
- Individuals with upper extremity spasm below 3 according to the modified Ashword scale (MAS)
Who cannot join
- Montreal Cognitive Assessment (MOCA) score of less than 21,
- Upper extremity spasticy of over 3 according to MAS,
- Patients with subluxation and fracture risk in the shoulder,
- Agnosia or visual impairment,
- Limited joint movement in the hemiplegic side upper extremity,
- Patients who have undergone any botulinum toxin application or surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF THERA-TRAINER BASED EXERCISES ON MOTOR AND COGNITIVE PERFORMANCE AMONG HEMİPARATİC STROKE PATIENTS. A RANDOMİSED CONTROL TRİAL
Technology-supported training supports the rehabilitation process by providing high-intensity, repetitive, and task-specific treatment, contributes to the recovery process, and facilitates the restoration of arm function (Bertani et al., 2017). Technology-supported rehabilitation studies for the upper extremity are performed using different devices. THERA-Trainer Tigo is used for the mobilization of individuals with limited mobility after trauma or due to any reason; it is suitable for passive movement training and active movement. Treatment with active-passive exercise devices facilitates rehabilitation with natural and rhythmic movements. It allows almost all patients, from wheelchair users to walkers, to actively participate in bicycle training during the rehabilitation process (Pazo et al., 2017). There are very few studies in the literature examining the relationship between cognitive and motor performance functions of THERA-Trainer-based exercises, and the aim of this study is to provide a preliminary idea in terms of progression to clinicians during the evaluation phase and treatment, to contribute to treatment, and to academic researchers.
Read the detailed description
Stroke is a leading cause of death and disability worldwide. It can be generally classified as ischemic stroke and hemorrhagic stroke. Ischemic stroke is defined as an infarction of the brain, spinal cord, or retina and accounts for approximately 70% of all strokes. Hemorrhagic stroke occurs as a result of intracerebral hemorrhage and subarachnoid hemorrhage (Campbell et al., 2019).Technology-assisted rehabilitation supports recovery by providing high-intensity, repetitive, and task-specific treatment, facilitating the restoration of upper limb function. Studies on technology-based rehabilitation for upper extremity recovery utilize various devices. The THERA-Trainer Tigo, for instance, is designed to mobilize individuals with restricted movement abilities caused by trauma or other conditions. It is suitable for both passive and active motion training. Therapy with active-passive exercise devices promotes rehabilitation through natural and rhythmic movements. It accommodates a wide range of patients-from wheelchair users to those capable of walking-by enabling nearly all individuals in the rehabilitation process to actively participate in cycling exercises .
However, there is a limited body of research exploring the relationship between cognitive and motor performance functions during THERA-Trainer-based exercises. This study aims to address this gap by providing clinicians with insights into progression during evaluation and treatment phases, enhancing therapeutic strategies, and contributing to the academic knowledge base for researchers.
- Conditions
- Stroke
- Being tested
- THERA-TRAINER BASED EXERCISES, FUNCTIONAL STROKE TRAİNİNG
- Keywords
- stroke, aerobic exercise, motor performance, cognitive performance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERA-TRAINER BASED EXERCISESOther
The interventions will carried out two days a week and 40 minutes for eight weeks
FUNCTIONAL STROKE TRAİNİNGOther
he interventions will carried out two days a week and 40 minutes for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| THERA-TRAINER BASED EXERCISES | Experimental | Participants in the exercise arm will engage in structured, Thera-Trainer-based exercise programs tailored to their motor and cognitive rehabilitation needs. The intervention focuses on combining motor and cognitive tasks to maximize recovery outcomes. Receives: Other: THERA-TRAINER BASED EXERCISES |
| Functional Stroke Training | Experimental | To enhance motor recovery, functional independence, and cognitive performance in stroke patients Receives: Other: FUNCTIONAL STROKE TRAİNİNG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental Test
The Mini Mental State Examination (MMSE) is a widely used tool for assessing cognitive function, particularly in screening for dementia and monitoring cognitive changes over time. It evaluates different cognitive domains, including orientation, registration, attention, calculation, recall, language, and visual-spatial skills.
Measured: Eight weeks
Digit Span Test
The Digit Span Test is a cognitive assessment tool used to evaluate working memory, attention, and concentration. It is often part of broader neuropsychological evaluations and can assess both forward and backward digit span.
Measured: Eight weeks
Frenchay Arm Test
The Frenchay Arm Test involves 5 tasks, each graded as pass (1 point) or fail (0 points) based on the patient's ability to complete the task. The tasks progress in difficulty and assess various aspects of upper limb function.
Measured: Eight weeks
Time Up Go Test (TUG)
The Timed Up and Go Test (TUG) is a simple and widely used assessment tool to evaluate mobility, balance, and functional independence. It is particularly useful for identifying fall risk in older adults and individuals with neurological or musculoskeletal impairments.
Measured: Eight weeks
Fugl Meyer Assesment
The test examines reflex activity, voluntary movements within, partially out and independent of synergies (22). The scale includes 33 items divided into 4 subscales: shoulder/elbow (A, 18 items), wrist (B, 5 items), hand (C, 7 items) and coordination/ speed (D, 3 items). Each item is scored on an ordinal 3-point scale, where 2 points are assigned when the movement is performed fully, 1 point when performed partially, and 0 points when the movement cannot be performed. A total score of 66 indicates better sensorimotor function
Measured: Eight weeks
Five Time Sit to Stand
The Five Times Sit-to-Stand Test (FTSST) is a simple, reliable, and functional test used to assess lower limb strength, balance, and mobility. It is widely applied in clinical and research settings for evaluating physical performance in various populations, including older adults and individuals with neuromuscular conditions.The individual sits in a standard chair (seat height ~43-45 cm) without armrests.The chair is placed against a wall or a stable surface to prevent movement.The participant starts seated with their back against the chair and feet flat on the floor, arms crossed over the chest.On the signal "Go," they are instructed to stand up fully and sit back down as quickly as possible, repeating this motion five times.The test begins at the word "Go" and ends when the participant fully stands after the fifth repetition.A stopwatch is used to record the total time taken.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start19 May 2024
- Primary completion15 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- The study was planned as a randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kübra ÇEKOK, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938477
- Sponsor's protocol ID
- 2
- Status last verified
- Jun 2025
- First submitted
- 14 Apr 2025
- Last updated
- 18 Jun 2025
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF THERA-TRAINER BASED EXERCISES ON MOTOR AND COGNITIVE PERFORMANCE AMONG HEMİPARATİC STROKE PATIENTS. A RANDOMİSED CONTROL TRİAL
- ClinicalTrials.gov ID
- NCT06938477
- Acronym / sponsor ID
- 2
- Conditions
- Stroke
- Keywords
- stroke, aerobic exercise, motor performance, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 22 Apr 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.
Technology-supported training supports the rehabilitation process by providing high-intensity, repetitive, and task-specific treatment, contributes to the recovery process, and facilitates the restoration of arm function (Bertani et al., 2017). Technology-supported rehabilitation studies for the upper extremity are performed using different devices. THERA-Trainer Tigo is used for the mobilization of individuals with limited mobility after trauma or due to any reason; it is suitable for passive movement training and active movement. Treatment with active-passive exercise devices facilitates rehabilitation with natural and rhythmic movements. It allows almost all patients, from wheelchair users to walkers, to actively participate in bicycle training during the rehabilitation process (Pazo et al., 2017). There are very few studies in the literature examining the relationship between cognitive and motor performance functions of THERA-Trainer-based exercises, and the aim of this study is to provide a preliminary idea in terms of progression to clinicians during the evaluation phase and treatment, to contribute to treatment, and to academic researchers.
Detailed description
Stroke is a leading cause of death and disability worldwide. It can be generally classified as ischemic stroke and hemorrhagic stroke. Ischemic stroke is defined as an infarction of the brain, spinal cord, or retina and accounts for approximately 70% of all strokes. Hemorrhagic stroke occurs as a result of intracerebral hemorrhage and subarachnoid hemorrhage (Campbell et al., 2019).Technology-assisted rehabilitation supports recovery by providing high-intensity, repetitive, and task-specific treatment, facilitating the restoration of upper limb function. Studies on technology-based rehabilitation for upper extremity recovery utilize various devices. The THERA-Trainer Tigo, for instance, is designed to mobilize individuals with restricted movement abilities caused by trauma or other conditions. It is suitable for both passive and active motion training. Therapy with active-passive exercise devices promotes rehabilitation through natural and rhythmic movements. It accommodates a wide range of patients-from wheelchair users to those capable of walking-by enabling nearly all individuals in the rehabilitation process to actively participate in cycling exercises .
However, there is a limited body of research exploring the relationship between cognitive and motor performance functions during THERA-Trainer-based exercises. This study aims to address this gap by providing clinicians with insights into progression during evaluation and treatment phases, enhancing therapeutic strategies, and contributing to the academic knowledge base for researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| THERA-TRAINER BASED EXERCISES | Experimental | Other: THERA-TRAINER BASED EXERCISESParticipants in the exercise arm will engage in structured, Thera-Trainer-based exercise programs tailored to their motor and cognitive rehabilitation needs. The intervention focuses on combining motor and cognitive tasks to maximize recovery outcomes. |
| Functional Stroke Training | Experimental | Other: FUNCTIONAL STROKE TRAİNİNGTo enhance motor recovery, functional independence, and cognitive performance in stroke patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having had an ischemic or hemorrhagic stroke for the first time
- Those with a Montreal Cognitive Assessment (MOCA) score above 21,
- Individuals with a functional level below 4 according to the modified Rankin scale (MRS),
- Individuals with upper extremity spasm below 3 according to the modified Ashword scale (MAS)
Key exclusion criteria (6 listed)
- Montreal Cognitive Assessment (MOCA) score of less than 21,
- Upper extremity spasticy of over 3 according to MAS,
- Patients with subluxation and fracture risk in the shoulder,
- Agnosia or visual impairment,
- Limited joint movement in the hemiplegic side upper extremity,
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 |
|---|---|---|
| THERA-TRAINER BASED EXERCISESThe interventions will carried out two days a week and 40 minutes for eight weeks | Other | THERA-TRAINER BASED EXERCISES |
| FUNCTIONAL STROKE TRAİNİNGhe interventions will carried out two days a week and 40 minutes for eight weeks | Other | Functional Stroke Training |
Primary outcome
Mini Mental Test
Time frame: Eight weeks
The Mini Mental State Examination (MMSE) is a widely used tool for assessing cognitive function, particularly in screening for dementia and monitoring cognitive changes over time. It evaluates different cognitive domains, including orientation, registration, attention, calculation, recall, language, and visual-spatial skills.
Digit Span Test
Time frame: Eight weeks
The Digit Span Test is a cognitive assessment tool used to evaluate working memory, attention, and concentration. It is often part of broader neuropsychological evaluations and can assess both forward and backward digit span.
Frenchay Arm Test
Time frame: Eight weeks
The Frenchay Arm Test involves 5 tasks, each graded as pass (1 point) or fail (0 points) based on the patient's ability to complete the task. The tasks progress in difficulty and assess various aspects of upper limb function.
Time Up Go Test (TUG)
Time frame: Eight weeks
The Timed Up and Go Test (TUG) is a simple and widely used assessment tool to evaluate mobility, balance, and functional independence. It is particularly useful for identifying fall risk in older adults and individuals with neurological or musculoskeletal impairments.
Fugl Meyer Assesment
Time frame: Eight weeks
The test examines reflex activity, voluntary movements within, partially out and independent of synergies (22). The scale includes 33 items divided into 4 subscales: shoulder/elbow (A, 18 items), wrist (B, 5 items), hand (C, 7 items) and coordination/ speed (D, 3 items). Each item is scored on an ordinal 3-point scale, where 2 points are assigned when the movement is performed fully, 1 point when performed partially, and 0 points when the movement cannot be performed. A total score of 66 indicates better sensorimotor function
Five Time Sit to Stand
Time frame: Eight weeks
The Five Times Sit-to-Stand Test (FTSST) is a simple, reliable, and functional test used to assess lower limb strength, balance, and mobility. It is widely applied in clinical and research settings for evaluating physical performance in various populations, including older adults and individuals with neuromuscular conditions.The individual sits in a standard chair (seat height ~43-45 cm) without armrests.The chair is placed against a wall or a stable surface to prevent movement.The participant starts seated with their back against the chair and feet flat on the floor, arms crossed over the chest.On the signal "Go," they are instructed to stand up fully and sit back down as quickly as possible, repeating this motion five times.The test begins at the word "Go" and ends when the participant fully stands after the fifth repetition.A stopwatch is used to record the total time taken.
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 18 Jun 2025.
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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 THERA-TRAINER BASED EXERCISES and FUNCTIONAL STROKE TRAİNİNG in people with Stroke, run by Tarsus 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 4 inclusion and 6 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 18 Jun 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?
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?
Mini Mental Test (time frame: Eight weeks). The study lists 6 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 18 Jun 2025.