About this 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:
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with ischemic or hemorrhagic stroke
Have a stroke more than 6 months
Age between 18 and 70
Disqualifiers
Patients with severe cognitive impairments
Patients cannot walk independently
Trial design
Parallel
Treatments tested in this trial
NeuroReAlign Therapy
Other interventionPatients 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 interventions
Other interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: