Effects of NeuroReAlign Therapy on Balance and Gait in Stroke Survivors: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Dynamic Gait Index (DGI)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ischemic or hemorrhagic stroke
- •Have a stroke more than 6 months
- •Age between 18 and 70
排除标准
- •Patients with severe cognitive impairments
- •Patients cannot walk independently
研究组 & 干预措施
Conventional Physiotherapy
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.
干预措施: conventional physiotherapy interventions (Other)
NeuroReAlign Therapy
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.
干预措施: NeuroReAlign Therapy (Other)
结局指标
主要结局
Dynamic Gait Index (DGI)
时间窗: 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.
次要结局
- Berg Balance Scale (BBS)(At baseline (week 0) and post-intervention (week 4))
- Activities-Specific Balance Confidence Scale (ABC Scale)(At baseline (week 0) and post-intervention (week 4))
- Fear of Falling Questionnaire (FoFQ)(At baseline (week 0) and post-intervention (week 4))
- Rivermead Mobility Index (RMI)(At baseline (week 0) and post-intervention (week 4))
- Timed Up and Go (TUG)(At baseline (week 0) and post-intervention (week 4))
- 10-Meter Walk Test (10MWT)(At baseline (week 0) and post-intervention (week 4))
- 6-Minute Walk Test (6MWT)(At baseline (week 0) and post-intervention (week 4))
研究者
Anas Radi Hassan Alashram
Assistant Professor
Middle East University