Impact of combining high-dose high-intensity upper limb training with motor learning techniques on improving hand functions and overall quality of life in individuals with chronic stroke.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Fugyl-Meyer Assessment- Upper Extremity (FMA-UE)
概览
简要总结
**Title:**Impact of combining high-dose, high-intensity upper limb training with motor learning techniques on improving hand functions and overall quality of life in individuals with chronic stroke.
**Background:**Stroke incidence in India is high (1.44–1.66 million new cases annually), with 86.5 deaths per 100,000 yearly. Over 90% of survivors experience upper limb motor dysfunction, leading to long-term disability—66% remain dependent on daily activities five years post-stroke. Current rehabilitation focuses on lower limbs, while upper limb recovery plateaus after three months due to insufficient therapy intensity and limited integration of motor learning strategies.
Objectives:
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Assess the impact of high-dose, high-intensity upper limb training combined with motor learning techniques on Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Action Research Arm Test (ARAT) and Jebsen-Taylor Hand Function Test (JTHFT)
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Reduce upper limb impairments (Modified Ashworth Scale, range of motion).
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Enhance quality of life (Stroke-Specific Quality of Life Scale, SS-QOL).
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Investigate associations between age, sex, stroke laterality (dominant/non-dominant), and recovery.
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Evaluate maintenance of benefits at 6-week follow-up.
Methods:
- Design: Randomized controlled trial (70 participants, 35 per group).
- Population: Chronic stroke patients (>3 months post-stroke) with upper limb impairment.
- Intervention Group: 4-week protocol: 2 hours/day, 5 days/week (40 total hours) of high dose, high-intensity upper limb training + motor learning strategies (task-specific practice, feedback). Adjunct: Aerobic exercise (1 hour/day, 2 days/week). FITT-based: Tailored to ACSM guidelines for stroke.
- Control Group: Standard rehabilitation (passive stretches, joint mobilizations).
- Outcome Measures: Baseline, post-intervention (4 weeks), and follow-up (6 weeks) assessments of FMA-UE, ARAT, JTHFT, and SS-QOL
**Significance:**This trial addresses the critical gap in upper limb rehabilitation by combining high-dose training (time/repetitions) with motor learning techniques to promote neuroplasticity and functional recovery in chronic stroke. It challenges the post-3-month recovery plateau and aims to establish a scalable, evidence-based protocol for improving hand function, independence, and quality of life. Results may form clinical guidelines for aggressive, integrated upper limb rehabilitation in resource-limited settings.
**Innovation:**First study in India to integrate high-dose training (40 hours) with motor learning strategies in chronic stroke, targeting long-term functional gains and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •a) A first-ever unilateral stroke (ischaemic or haemorrhagic) as defined by WHO, at least 6-months previously. b) Moderate upper limb impairment as defined by Fugyl-Meyer Assessment.
- •Upper Extremity (Woodbury et al., 2007) score between 19-46 (to avoid ceiling and floor effects) c) Trace of muscle contraction in wrist extensor. Max 4 on the (Medical RCS) for shoulder elevation and elbow flexion/extension. d) Ability to follow 2 step commands.
排除标准
- •a) Other neurological diagnoses.
- •b) Serious cognitive impairment.
- •c) Increased muscle tone in wrist/finger extensors.
- •d) Orthopaedic Impairment or Visual disorder limiting the treatment.
- •e) Unable to give informed consent form.
结局指标
主要结局
Fugyl-Meyer Assessment- Upper Extremity (FMA-UE)
时间窗: Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups.
次要结局
- Action Research Arm Test (ARAT)(Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups.)
- Jebsen-Taylor Hand Function Test (JTHFT)(Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups)
- Stroke-Specific Quality of Life Scale (SS-QOL)(Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups.)
研究者
Dr Nirav P Vaghela
K. M. Patel Institute of Physiotherapy Bhaikaka University