Targeted Ankle Proprioceptive Training Improves Balance, Gait, and Functional Mobility in Chronic Stroke Survivors: A Multicenter Randomized Controlled Trial With Longitudinal Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
Stroke is a leading cause of long-term disability, with balance and gait deficits affecting >80% of survivors and increasing fall risk. Emerging evidence links ankle proprioceptive impairment-particularly inversion/eversion acuity-to these deficits, often bilateral and central in origin. Cross-sectional studies show strong associations, but causality, temporal progression, and intervention efficacy (especially in severe/non-ambulatory cases) remain unproven. This trial tests a targeted proprioceptive protocol against standard care.
详细描述
Objectives: Primary: To evaluate the causal effect of 12-week targeted ankle proprioceptive training on weight-bearing ankle proprioception (AMEDA) in chronic stroke survivors.
Secondary: To assess effects on balance (Berg Balance Scale), gait speed (10m walk test), mobility (Timed Up and Go, Functional Ambulation Category), lower extremity motor function (Fugl-Meyer), and sustainability at 6-month follow-up. To describe longitudinal proprioceptive changes in a subsample from acute to chronic stages.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic ischemic/hemorrhagic stroke (≥12 months post-stroke)
- •Moderate-to-severe lower extremity impairment (Fugl-Meyer LE ≤28 or NIHSS motor leg ≥2)
- •Documented ankle proprioceptive deficit (AMEDA AUC <0.7)
排除标准
- •Acute medical issues (e.g., uncontrolled hypertension)
- •Severe cognitive impairment (MMSE <24)
- •Exercise contraindications
- •Concurrent conflicting trials
研究组 & 干预措施
Phase 1 (Weeks 1-4)
Robotic-assisted sensory discrimination (inversion/eversion, plantar/dorsiflexion; reduce angles, remove visual feedback).
干预措施: Gait training (Other)
Phase 2 (Weeks 5-8)
Functional weight-bearing challenges (e.g., balance boards, textured surfaces, dynamic tasks).
干预措施: Gait training (Other)
Phase 3 (Weeks 9-12)
Advanced integration (e.g., gait with proprioceptive cues, dual task)
干预措施: Gait training (Other)
结局指标
主要结局
Primary outcome
时间窗: post-12 weeks, 6-month follow-up. Longitudinal subsample assessed from acute (<1 month) to chronic.
Active Movement Extent Discrimination Apparatus for measuring propioceptive acuity
次要结局
- Secondary outcome(post-12 weeks, 6-month follow-up. Longitudinal subsample assessed from acute (<1 month) to chronic.)
研究者
Muslim khan
Assistant Professor
Iqra National University