StrokeNCT06849128
NeuroReAlign Therapy for Cognitive Rehabilitation in Patients with Stroke
A study testing NeuroReAlign Therapy and Conventional cognitive training in people with Stroke, run by Middle East University.
Trial summary
The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on cognition in stroke survivors in the chronic stage (>6 months). The study will include male and female participants aged 18-70 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- NeuroReAlign Therapy and Conventional cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 30 Apr 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ischemic or hemorrhagic stroke
- Have a stroke more than 6 months
- Age between 18 and 70
Who cannot join
- Patients with severe cognitive impairments
- Patients cannot walk independently
About this study
Official title: Effects of NeuroReAlign Therapy on Cognition in Patients with Stroke: a Randomized Controlled Trial
The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on cognition in stroke survivors in the chronic stage (>6 months). The study will include male and female participants aged 18-70 years.
The main questions it aims to answer are:
Read more
Does NeuroReAlign Therapy improve cognition in stroke survivors compared to conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional cognitive therapy to determine its effects on cognition.
Participants will:
Undergo NeuroReAlign Therapy or conventional cognitive therapy for 4 weeks. Have their cognition evaluated using the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Trail Making Test (TMT), Stroop Test, Digit Span Test, and Verbal Fluency Test (VFT).
Complete outcome assessments at baseline and after the intervention (week 4).
- Conditions
- Stroke
- Being tested
- NeuroReAlign Therapy, Conventional cognitive training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroReAlign TherapyOther
Patients in this group will receive NeuroReAlign Therapy, including motor training (e.g., treadmill training, balance training), multimodal sensory stimulation (e.g., proprioceptive and visual), cognitive training (e.g., traditional cognitive exercise), and motivation, for 45 minutes per session, 3 times weekly, for 4 weeks.
Conventional cognitive trainingOther
A conventional cognitive training protocol involves structured, repetitive exercises designed to enhance specific cognitive functions, such as memory, attention, executive function, and processing speed. These training programs are delivered through paper-and-pencil tasks, computer-based exercises, and therapist-guided activities. Tasks used include working memory exercises (e.g., digit span recall), attention training (e.g., Stroop test, visual scanning), problem-solving activities (e.g., Tower of Hanoi), and language exercises (e.g., verbal fluency tasks), for 45 minutes per session, 3 times weekly, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conventional cognitive training | Active comparator | A conventional cognitive training protocol involves structured, repetitive exercises designed to enhance specific cognitive functions, such as memory, attention, executive function, and processing speed. These training programs are delivered through paper-and-pencil tasks, computer-based exercises, and therapist-guided activities. Tasks used include working memory exercises (e.g., digit span recall), attention training (e.g., Stroop test, visual scanning), problem-solving activities (e.g., Tower of Hanoi), and language exercises (e.g., verbal fluency tasks), for 45 minutes per session, 3 times weekly, for 4 weeks. Receives: Other: Conventional cognitive training |
| NeuroReAlign Therapy | Experimental | Patients in this group will receive NeuroReAlign Therapy, including motor training (e.g., treadmill training, balance training), multimodal sensory stimulation (e.g., proprioceptive and visual), cognitive training (e.g., traditional cognitive exercise), and motivation, for 45 minutes per session, 3 times weekly, for 4 weeks. Receives: Other: NeuroReAlign Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to assess mild cognitive impairment in stroke survivors and other neurological populations. It evaluates multiple cognitive domains, including attention, memory, visuospatial abilities, executive function, language, and orientation. The test consists of 30 points, with a cutoff score of <26 suggesting cognitive impairment. The MoCA is sensitive to subtle cognitive deficits and is particularly useful in detecting post-stroke cognitive impairments that may not be captured by other general cognitive tests.
Measured: At baseline (week 0) and post-intervention (week 4)
Secondary outcomes (5)
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a brief, standardized cognitive test used to assess overall cognitive function in stroke survivors. It evaluates orientation, attention, memory, language, and visuospatial skills, with a total score of 30 points. Lower scores indicate greater cognitive impairment, with a cutoff of ≤24 typically suggesting cognitive dysfunction. Although widely used, the MMSE may be less sensitive to detecting mild cognitive impairment compared to the Montreal Cognitive Assessment (MoCA).
Measured: At baseline (week 0) and post-intervention (week 4)
Trail Making Test (TMT)
The Trail Making Test (TMT) is a neuropsychological test used to assess processing speed, attention, and executive function in stroke survivors. It consists of two parts: TMT part A, where participants connect numbers in ascending order to measure processing speed and visual search, and TMT part B, where they alternate between numbers and letters (1-A-2-B, etc.) to assess cognitive flexibility and executive function. Longer completion times indicate greater impairment. The TMT is widely used to evaluate cognitive deficits following stroke, particularly in domains related to attention and task-switching.
Measured: At baseline (week 0) and post-intervention (week 4)
Stroop Test
The Stroop Test assesses cognitive control, attention, and response inhibition, which are often affected after a stroke. It requires participants to name the color of printed words while ignoring the actual word meaning (e.g., saying "blue" when the word "RED" is printed in blue ink). The test measures processing speed, selective attention, and executive function by evaluating the ability to suppress automatic responses. Poor performance on the Stroop Test may indicate deficits in cognitive control and attention regulation, which are common in post-stroke cognitive impairment.
Measured: At baseline (week 0) and post-intervention (week 4)
Digit Span Test
The Digit Span Test, a subtest of the Wechsler Adult Intelligence Scale (WAIS), assesses attention, working memory, and verbal short-term memory. Participants are asked to repeat a series of numbers in the same order (forward digit span) or in reverse order (backward digit span). The backward span is particularly sensitive to working memory deficits, which are frequently observed in stroke survivors. This test is simple yet effective in evaluating short-term memory and cognitive processing capacity.
Measured: At baseline (week 0) and post-intervention (week 4)
Verbal Fluency Test (VFT)
The Verbal Fluency Test (VFT) measures language function, executive control, and processing speed. It consists of two types: phonemic fluency, where participants generate words starting with a specific letter, and semantic fluency, where they list words within a given category (e.g., animals). The number of correct words generated within a time limit (usually 60 seconds) reflects cognitive function, with lower scores indicating language or executive dysfunction. This test is commonly used to assess cognitive deficits in post-stroke patients, particularly those affecting language and retrieval ability.
Measured: At baseline (week 0) and post-intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Radi Hassan Alashram, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849128
- Sponsor's protocol ID
- ADA/1100
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NeuroReAlign Therapy on Cognition in Patients with Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06849128
- Acronym / sponsor ID
- ADA/1100
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 27 Feb 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 randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on cognition in stroke survivors in the chronic stage (>6 months). The study will include male and female participants aged 18-70 years.
The main questions it aims to answer are:
Does NeuroReAlign Therapy improve cognition in stroke survivors compared to conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional cognitive therapy to determine its effects on cognition.
Participants will:
Undergo NeuroReAlign Therapy or conventional cognitive therapy for 4 weeks. Have their cognition evaluated using the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Trail Making Test (TMT), Stroop Test, Digit Span Test, and Verbal Fluency Test (VFT).
Complete outcome assessments at baseline and after the intervention (week 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional cognitive training | Active comparator | Other: Conventional cognitive trainingA conventional cognitive training protocol involves structured, repetitive exercises designed to enhance specific cognitive functions, such as memory, attention, executive function, and processing speed. These training programs are delivered through paper-and-pencil tasks, computer-based exercises, and therapist-guided activities. Tasks used include working memory exercises (e.g., digit span recall), attention training (e.g., Stroop test, visual scanning), problem-solving activities (e.g., Tower of Hanoi), and language exercises (e.g., verbal fluency tasks), for 45 minutes per session, 3 times weekly, for 4 weeks. |
| NeuroReAlign Therapy | Experimental | Other: NeuroReAlign TherapyPatients in this group will receive NeuroReAlign Therapy, including motor training (e.g., treadmill training, balance training), multimodal sensory stimulation (e.g., proprioceptive and visual), cognitive training (e.g., traditional cognitive exercise), and motivation, for 45 minutes per session, 3 times weekly, for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ischemic or hemorrhagic stroke
- Have a stroke more than 6 months
- Age between 18 and 70
Key exclusion criteria (2 listed)
- Patients with severe cognitive impairments
- Patients cannot walk independently
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 |
|---|---|---|
| NeuroReAlign TherapyPatients in this group will receive NeuroReAlign Therapy, including motor training (e.g., treadmill training, balance training), multimodal sensory stimulation (e.g., proprioceptive and visual), cognitive training (e.g., traditional cognitive exercise), and motivation, for 45 minutes per session, 3 times weekly, for 4 weeks. | Other | NeuroReAlign Therapy |
| Conventional cognitive trainingA conventional cognitive training protocol involves structured, repetitive exercises designed to enhance specific cognitive functions, such as memory, attention, executive function, and processing speed. These training programs are delivered through paper-and-pencil tasks, computer-based exercises, and therapist-guided activities. Tasks used include working memory exercises (e.g., digit span recall), attention training (e.g., Stroop test, visual scanning), problem-solving activities (e.g., Tower of Hanoi), and language exercises (e.g., verbal fluency tasks), for 45 minutes per session, 3 times weekly, for 4 weeks. | Other | Conventional cognitive training |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: At baseline (week 0) and post-intervention (week 4)
The Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to assess mild cognitive impairment in stroke survivors and other neurological populations. It evaluates multiple cognitive domains, including attention, memory, visuospatial abilities, executive function, language, and orientation. The test consists of 30 points, with a cutoff score of <26 suggesting cognitive impairment. The MoCA is sensitive to subtle cognitive deficits and is particularly useful in detecting post-stroke cognitive impairments that may not be captured by other general cognitive tests.
5 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: At baseline (week 0) and post-intervention (week 4)
Trail Making Test (TMT)
Time frame: At baseline (week 0) and post-intervention (week 4)
Stroop Test
Time frame: At baseline (week 0) and post-intervention (week 4)
Digit Span Test
Time frame: At baseline (week 0) and post-intervention (week 4)
Verbal Fluency Test (VFT)
Time frame: At baseline (week 0) and post-intervention (week 4)
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 18 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroReAlign Therapy and Conventional cognitive training in people with Stroke, run by Middle East University.
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 3 inclusion and 2 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Montreal Cognitive Assessment (MoCA) (time frame: At baseline (week 0) and post-intervention (week 4)). 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 Mar 2025.