Effect Of Task-Specific Training With And Without Biofeedback On Balance And Risk Of Falls In Chronic Ischemic Stroke Patients Of Central Lahore, Pakistan, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Balance performance as measured by Berg Balance Scale (BBS)
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of task-specific training with and without biofeedback compared to conventional physical therapy on balance and fall risk in chronic ischemic stroke patients in Lahore, Pakistan. Sixty-six participants will be randomly allocated into three groups: Group 1 (task-specific training with biofeedback), Group 2 (task-specific training without biofeedback), and Group 3 (conventional physical therapy). The intervention will span 12 weeks, consisting of 36 sessions. Key outcome measures include the Berg Balance Scale, Timed Up and Go Test, and the Barthel Index. Assessments will be conducted at baseline, post-intervention, and three-month follow-up. The study hypothesizes that the use of biofeedback in task-specific training will produce significantly greater improvements in balance and reduced fall risk compared to conventional rehabilitation strategies. The study is being conducted at Shadman Medical Center in Lahore and is part of a PhD project from Lincoln University College.
详细描述
This randomized controlled trial investigates the comparative effectiveness of task-specific training with biofeedback, without biofeedback, and conventional physical therapy in improving balance and reducing fall risk among chronic ischemic stroke patients. The study consists of 66 participants, randomly assigned to three groups. Group 1 receives task-specific training using the Motor Relearning Program (MRP) principles, augmented with virtual reality-based biofeedback. Group 2 follows the same task-specific training without biofeedback. Group 3 receives conventional physical therapy following standard post-stroke rehabilitation protocols.
Participants will undergo 36 treatment sessions over a 12-week period, with three one-hour sessions per week. All interventions are delivered by qualified physiotherapists at the Department of Neurological and Functional Rehabilitation, Shadman Medical Center, Lahore.
Outcomes will be assessed using the Berg Balance Scale (BBS), Timed Up and Go (TUG) test, and the Barthel Index (BI) at baseline, post-intervention, and a 3-month follow-up. Randomization will be computer-generated, with blinding applied to assessors and data analysts.
The primary objective is to examine whether task-specific training with biofeedback significantly improves dynamic and static balance and reduces fall risk more effectively than the other two methods. Data will be analyzed using SPSS v21.0, applying repeated measures ANOVA and Cohen's d for effect size. A p-value ≤ 0.05 will be considered statistically significant.
The study has received ethical approval from Lincoln University College and is conducted under informed consent. Results will contribute to doctoral research and be submitted for peer-reviewed publication and presentation at scientific forums.
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)
盲法说明
The outcome assessor will be blinded to group allocation. Due to the nature of the intervention, therapists and participants cannot be blinded.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic ischemic stroke patients (more than 3 months after stroke) Both Male and Female Patients Patients of 40 or above years of age Patients with Burnstorm stage 3 or above.) Patients with good cognitive function (score of 20 or more on MMSE) Patients who can ambulate 10 m (with or without the assistive device)
排除标准
- •Patients undergoing concurrent therapy or treatment that could influence the effectiveness of this study will be excluded from participation Patients presenting with contraindications to rehabilitation, such as severe uncontrolled hypertension, uncontrolled diabetes, or unstable angina, will be excluded from the study.
- •Individuals with prior neurological impairments apart from stroke.
研究组 & 干预措施
Task-Specific Training with Biofeedback
Participants in this group will receive task-specific training combined with biofeedback. The intervention will focus on functional activities that challenge balance and mobility, while real-time feedback will be provided to improve motor control and postural stability. Training will be conducted under supervision for a set duration and frequency over the intervention period.
干预措施: Task-Specific Training with Biofeedback (Behavioral)
Task-Specific Training without Biofeedback
Participants in this group will receive the same task-specific training protocol without biofeedback. Functional tasks will be practiced to enhance balance and reduce fall risk. Training will be identical in duration and intensity to the experimental group but will not include feedback mechanisms.
干预措施: Task-Specific Training without Biofeedback (Behavioral)
Control Group
Participants in this group will receive conventional post-stroke physical therapy following standard rehabilitation protocols. Interventions will include strengthening, stretching, balance exercises, and functional mobility tasks. The duration and frequency will match the experimental groups (three 1-hour sessions per week for 12 weeks).
干预措施: conventional stroke rehabilitation (Behavioral)
结局指标
主要结局
Balance performance as measured by Berg Balance Scale (BBS)
时间窗: Baseline (T0), Post-intervention (12 weeks, T2), and Follow-up (3 months post-intervention, TX)
The BBS will assess balance performance across 14 items related to functional tasks such as sitting, standing, reaching, and turning. It is a widely validated tool in stroke rehabilitation.
次要结局
- Risk of falls as measured by the Timed Up and Go (TUG) test(Baseline, Post-intervention (12 weeks), and Follow-up (3 months))
研究者
Syed Ali Behram Subazwari
Principal Investigator
Lincoln University College