StrokeNCT06849102
NeuroReAlign Therapy for Balance and Gait Rehabilitation in Stroke Survivors
A study testing NeuroReAlign Therapy and conventional physiotherapy interventions 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 balance and gait 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 physiotherapy interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 20 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 Balance and Gait in Stroke Survivors: a Randomized Controlled Trial
The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on balance and gait 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 balance in stroke survivors compared to conventional physiotherapy? Does NeuroReAlign Therapy enhance gait performance more effectively than conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional physiotherapy to determine its effects on balance and gait.
Participants will:
Undergo NeuroReAlign Therapy or conventional physiotherapy for 4 weeks. Have their balance assessed using the Berg Balance Scale (BBS), Activities-Specific Balance Confidence Scale (ABC Scale), and Fear of Falling Questionnaire (FoFQ).
Have their gait evaluated using the Dynamic Gait Index (DGI), Rivermead Mobility Index (RMI), Timed Up and Go (TUG), 6-Minute Walk Test (6MWT), and 10-Meter Walk Test (10MWT).
Complete outcome assessments at baseline and after the intervention (week 4).
- Conditions
- Stroke
- Being tested
- NeuroReAlign Therapy, conventional physiotherapy interventions
- 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 physiotherapy interventionsOther
Patients in this group will receive conventional physiotherapy interventions, including treadmill training, balance training, strengthening and stretching lower limb muscles, for 45 minutes per session, 3 times weekly, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Patients in this group will receive conventional physiotherapy interventions, including treadmill training, balance training, strengthening and stretching lower limb muscles, for 45 minutes per session, 3 times weekly, for 4 weeks. Receives: Other: conventional physiotherapy interventions |
| 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.
Dynamic Gait Index (DGI)
The Dynamic Gait Index (DGI) is a clinical tool designed to assess an individual's ability to adapt gait to varying task demands, particularly in populations with neurological conditions such as stroke, Parkinson's disease, and vestibular disorders. It consists of eight walking-related tasks, including changes in gait speed, head movements, obstacle navigation, and stair climbing, each scored on a 4-point scale (0-3), with a maximum total score of 24. Lower scores indicate greater impairment and a higher risk of falls, with a cutoff score of ≤19 suggesting increased fall risk. The DGI is widely used in rehabilitation settings to evaluate functional mobility, guide treatment planning, and monitor progress in individuals with balance and gait deficits.
Measured: At baseline (week 0) and after the intervention (week 4)
Secondary outcomes (7)
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is a widely used clinical assessment tool designed to evaluate balance in individuals, particularly in older adults or those with neurological conditions such as stroke. It consists of 14 tasks that assess a range of balance activities, including sitting, standing, reaching, turning, and stepping. Each task is scored on a scale from 0 to 4, with a maximum total score of 56. A higher score indicates better balance, while lower scores suggest a greater risk of falling. The BBS is a reliable and valid tool for both clinical assessments and monitoring balance over time, making it a key measure in rehabilitation settings for individuals with balance impairments.
Measured: At baseline (week 0) and post-intervention (week 4)
Activities-Specific Balance Confidence Scale (ABC Scale)
The Activities-Specific Balance Confidence Scale (ABC Scale) is a self-reported measure used to assess an individual's confidence in maintaining balance while performing various daily activities. The scale consists of 16 items, each asking the participant to rate their confidence (on a percentage scale from 0% to 100%) in performing specific tasks, such as walking, climbing stairs, or moving around the house, without losing balance or becoming unsteady. A higher score reflects greater confidence in balance, while lower scores indicate fear of falling or instability. The ABC Scale is widely used in clinical settings to evaluate balance confidence, identify fall risk, and track changes over time, especially in populations with balance and mobility impairments, such as those recovering from stroke or other neurological conditions.
Measured: At baseline (week 0) and post-intervention (week 4)
Fear of Falling Questionnaire (FoFQ)
The Fear of Falling Questionnaire (FoFQ) is a clinical tool used to assess an individual's fear of falling, which is often associated with decreased mobility, balance issues, and increased fall risk. It consists of several questions that explore the level of concern a person has about falling in various situations, such as walking in different environments or performing daily activities. The questionnaire typically uses a Likert scale to rate the intensity of fear, with higher scores indicating greater fear of falling. The FoFQ helps identify individuals at risk of avoiding activities due to fear of falling, which can lead to reduced physical function and further decline in mobility. It is widely used in rehabilitation and geriatric care to assess fear of falling, guide interventions, and monitor progress in patients with balance disorders or neurological conditions.
Measured: At baseline (week 0) and post-intervention (week 4)
Rivermead Mobility Index (RMI)
The Rivermead Mobility Index (RMI) is a clinical assessment tool used to measure mobility in individuals with neurological conditions, particularly those recovering from stroke or other brain injuries. It consists of 15 items that evaluate a range of mobility tasks, such as sitting, standing, walking, and transferring between different positions. Each task is scored on a scale from 0 to 15, with higher scores indicating greater mobility. The RMI is designed to assess both basic functional movements and more complex mobility tasks, making it suitable for tracking changes in functional ability over time. It is a reliable and valid measure widely used in rehabilitation settings to evaluate and monitor recovery progress, guide treatment plans, and predict outcomes in individuals with mobility impairments.
Measured: At baseline (week 0) and post-intervention (week 4)
Timed Up and Go (TUG)
The Timed Up and Go (TUG) test is a simple and widely used clinical assessment tool to evaluate mobility, balance, and fall risk in individuals, particularly those with neurological conditions or the elderly. The test involves timing how long it takes a person to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down again. The total time taken to complete the task is recorded, with longer times indicating poorer mobility and a higher risk of falling. The TUG is a quick, efficient, and reliable test that can be used to assess functional mobility in various clinical and rehabilitation settings, offering valuable insights into an individual's ability to perform basic mobility tasks independently.
Measured: At baseline (week 0) and post-intervention (week 4)
10-Meter Walk Test (10MWT)
The 10-Meter Walk Test (10MWT) is a widely used clinical measure to assess walking speed and gait function in individuals, particularly in those with neurological conditions or mobility impairments. The test involves timing how long it takes a person to walk a distance of 10 meters at their usual pace, and the walking speed is calculated by dividing the time taken by the distance. The 10MWT is a reliable indicator of mobility and can be used to assess walking performance, identify walking abnormalities, and evaluate improvements over time, making it especially useful in rehabilitation and clinical settings. Faster times generally indicate better functional mobility, while slower times may suggest gait difficulties or higher fall risk.
Measured: At baseline (week 0) and post-intervention (week 4)
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test (6MWT) is a simple, reliable, and widely used outcome measure that assesses a person's walking endurance and functional capacity. During the test, participants are instructed to walk as far as possible over a 6-minute period on a flat, hard surface, typically a 30-meter or 50-foot corridor. The distance covered within the allotted time is recorded as the primary outcome. The 6MWT evaluates not only gait speed but also the individual's cardiovascular and muscular endurance, making it an important tool for assessing the overall functional mobility of individuals, particularly those with neurological or musculoskeletal disorders, such as stroke. It is commonly used to assess the effects of interventions like rehabilitation or exercise training on walking endurance, and can also be used to monitor progress or decline over time.
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 start1 Mar 2025 (estimated)
- Primary completion10 Apr 2025 (estimated)
- Study completion20 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
- NCT06849102
- Sponsor's protocol ID
- ADA/1099
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 27 Feb 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NeuroReAlign Therapy on Balance and Gait in Stroke Survivors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06849102
- Acronym / sponsor ID
- ADA/1099
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 20 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 balance and gait 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 balance in stroke survivors compared to conventional physiotherapy? Does NeuroReAlign Therapy enhance gait performance more effectively than conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional physiotherapy to determine its effects on balance and gait.
Participants will:
Undergo NeuroReAlign Therapy or conventional physiotherapy for 4 weeks. Have their balance assessed using the Berg Balance Scale (BBS), Activities-Specific Balance Confidence Scale (ABC Scale), and Fear of Falling Questionnaire (FoFQ).
Have their gait evaluated using the Dynamic Gait Index (DGI), Rivermead Mobility Index (RMI), Timed Up and Go (TUG), 6-Minute Walk Test (6MWT), and 10-Meter Walk Test (10MWT).
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 Physiotherapy | Active comparator | Other: conventional physiotherapy interventionsPatients in this group will receive conventional physiotherapy interventions, including treadmill training, balance training, strengthening and stretching lower limb muscles, 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 physiotherapy interventionsPatients in this group will receive conventional physiotherapy interventions, including treadmill training, balance training, strengthening and stretching lower limb muscles, for 45 minutes per session, 3 times weekly, for 4 weeks. | Other | Conventional Physiotherapy |
Primary outcome
Dynamic Gait Index (DGI)
Time frame: At baseline (week 0) and after the intervention (week 4)
The Dynamic Gait Index (DGI) is a clinical tool designed to assess an individual's ability to adapt gait to varying task demands, particularly in populations with neurological conditions such as stroke, Parkinson's disease, and vestibular disorders. It consists of eight walking-related tasks, including changes in gait speed, head movements, obstacle navigation, and stair climbing, each scored on a 4-point scale (0-3), with a maximum total score of 24. Lower scores indicate greater impairment and a higher risk of falls, with a cutoff score of ≤19 suggesting increased fall risk. The DGI is widely used in rehabilitation settings to evaluate functional mobility, guide treatment planning, and monitor progress in individuals with balance and gait deficits.
7 secondary outcomes
Berg Balance Scale (BBS)
Time frame: At baseline (week 0) and post-intervention (week 4)
Activities-Specific Balance Confidence Scale (ABC Scale)
Time frame: At baseline (week 0) and post-intervention (week 4)
Fear of Falling Questionnaire (FoFQ)
Time frame: At baseline (week 0) and post-intervention (week 4)
Rivermead Mobility Index (RMI)
Time frame: At baseline (week 0) and post-intervention (week 4)
Timed Up and Go (TUG)
Time frame: At baseline (week 0) and post-intervention (week 4)
10-Meter Walk Test (10MWT)
Time frame: At baseline (week 0) and post-intervention (week 4)
6-Minute Walk Test (6MWT)
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 27 Feb 2025.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 physiotherapy interventions 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 27 Feb 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?
Dynamic Gait Index (DGI) (time frame: At baseline (week 0) and after the 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 27 Feb 2025.