The Effect of Combined Versus Sequential Attentional Focus Instructions on Upper Extremity Function in Subacute Stroke Patients: An Assessor-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Fugl Meyer Assessment- Upper Extremity Subscore
研究概览
简要总结
Stroke is a leading cause of long-term disability, and upper extremity impairments-affecting about 80% of survivors-limit functional reach, grasp, and manipulation more severely than lower limb deficits. Despite partial recovery of walking ability, meaningful functional use of the paretic arm remains limited. Conventional rehabilitation often lacks sufficient intensity, task specificity, and motor learning principles, highlighting the need for more effective approaches.
The subacute phase of stroke (up to 6 months post-onset) represents a period of heightened neuroplasticity and strong rehabilitation potential. During this time, integrating cognitive and motor training-such as attentional focus strategies-has gained attention. External focus enhances movement efficiency through motor automaticity, whereas internal focus supports early motor control. Evidence suggests that combining these strategies may optimize recovery, yet their relative effectiveness in stroke rehabilitation remains unclear.
Two main instructional approaches exist: combined attentional focus (internal and external cues delivered within the same session) and sequential attentional focus (internal focus first, followed by external focus as control improves). While both show therapeutic promise, comparative data in stroke populations are lacking.
This study aims to compare combined versus sequential attentional focus instructions in improving upper extremity function in subacute stroke. We hypothesize that a combined approach-starting with internal focus early, then integrating external focus-will yield superior motor improvements.
详细描述
Stroke is a major global cause of long-term disability. Upper extremity deficits are particularly common, affecting nearly 80% of individuals after stroke and manifesting as weakness, impaired selective motor control, abnormal muscle tone, sensory disturbances, and reduced coordination. These deficits cause substantial limitations in functional reach, grasp, and object manipulation, and they persist more severely compared with lower extremity impairments. Although most stroke survivors regain some degree of independent ambulation, only a minority recover meaningful functional use of the paretic upper limb, resulting in a disproportionately higher disability burden for the upper extremity.
Conventional rehabilitation often shows limited effectiveness in improving upper extremity outcomes because training intensity is typically insufficient, task specificity is restricted, and interventions do not consistently apply established motor learning principles. These challenges underscore the need for new therapeutic perspectives that more effectively harness neuroplasticity through high-intensity, task-oriented, and motor learning-based approaches tailored to the complex demands of upper extremity recovery.
Upper-extremity motor functions, which are often severely impaired in the acute phase of stroke, gradually begin to recover during the transition into the subacute period as spontaneous neurobiological repair processes become more active. Subacute stroke refers to the recovery phase that begins after the first week post-onset and extends through the early months, during which spontaneous biological recovery and neuroplasticity remain highly active. Although many frameworks define the core subacute window as the first 3 months, functional recovery and rehabilitation responsiveness continue meaningfully up to 6 months, which is widely accepted as the upper limit of the subacute period in clinical research and guideline-based stroke classification. Therefore, including patients within the first 6 months post-stroke ensures enrolment during a period of high rehabilitative potential.
In recent years, the integration of physical exercise and cognitive training has emerged as a promising strategy for enhancing both cognitive and motor functions in rehabilitation. One example of combining motor tasks with cognitive components is attentional focus training, which includes external and internal attentional focus strategies. External attentional focus directs the learner's attention to the effects of movement (e.g., "focus on the movement of the ball") and has been consistently shown to enhance movement efficiency and task performance. This effect is believed to occur through increased motor automaticity and reduced conscious interference. Conversely, internal attentional focus emphasizes the mechanical components of body movements (e.g.,'focus on your hand position') and can support the development of foundational motor control, particularly during the early stages of motor learning and recovery.
Recent evidence suggests that both internal and external attentional focus strategies can complement each other in therapeutic contexts. Internal focus (IF) supports early stroke rehabilitation by enhancing basic motor control, whereas external focus (EF) improves movement efficiency and functional parameters in later stages. EF has also been reported to outperform IF in improving upper extremity performance in stroke populations. These findings suggest that combining IF and EF-either simultaneously or in a structured progression-may better align with the evolving demands of stroke recovery.
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
Outcome assessors are blinded to group allocation to ensure unbiased measurement of upper extremity function. Interventionists delivering the rehabilitation sessions are not blinded due to the need to provide group-specific attentional focus instructions. Participants are aware of the type of instructions they receive, but they are not informed of the study hypothesis or comparative group details. This single-assessor blinded design minimizes bias while maintaining intervention fidelity.
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years at enrollment (Kwakkel et al., 1996; Coupar et al., 2012).
- •Stroke diagnosed by a neurologist between 1 week and 6 months before enrollment (Langhorne et al., 2020; Bernhardt et al., 2017).
- •Medically stable, as confirmed by a neurologist, with controlled and non-fluctuating vital signs (Stinear et al., 2020; Powers et al., 2019; Winstein et al., 2016).
- •Sufficient cognitive function to follow instructions, sustain attention, and actively participate in rehabilitation, as judged by the treating therapist (Stinear et al., 2020; Boyd et al., 2018).
- •Brunnstrom stage 2-5 in the affected upper limb (Brunnstrom, 1970; Langhorne et al., 2020).
- •Individuals with a Modified Ashworth Scale (MAS) score <3: Participants were required to have a MAS score of less than 3 in both the upper and lower extremities to ensure that spasticity remained at a manageable level and to allow safe participation in upper-limb motor rehabilitation (Pandyan et al., 2005; Li & Francisco, 2015; Ada et al., 2020).
- •Preserved corticospinal tract integrity, confirmed by a positive Motor Evoked Potential (MEP) response (Stinear et al., 2017; Byblow et al., 2015; Stinear et al., 2020).
- •Moderate to severe upper-extremity motor impairment, determined by Fugl-Meyer Assessment (FMA) scores of 0-47 (0-19 severe, 20-47 moderate) (Fugl-Meyer et al., 1975).
排除标准
- •Spasticity level: Individuals with a Modified Ashworth Scale (MAS) score ≥3 in either the upper or lower extremities were excluded, as marked hypertonicity and severe spastic contractions could negatively affect proximal stabilization and movement strategies, thereby interfering with upper-limb task performance (Pandyan et al., 2005).
- •Fractures: Participants with a current or recent fracture on the affected side of the body were excluded from the study.
- •Botulinum toxin injections: Individuals who had received Botulinum Toxin (Botox) injections within the previous three months were excluded due to the potential effects of the intervention on muscle tone and motor performance.
- •Communication disorders: Participants with motor or global aphasia, or other communication impairments that could interfere with understanding instructions or performing the required tasks, were excluded.
- •Concurrent rehabilitation: Individuals who were concurrently receiving rehabilitation treatment at another facility were excluded to prevent potential confounding effects from parallel interventions (Winstein et al., 2016).
- •Non-adherence to treatment sessions: Participants who failed to attend all required treatment sessions were excluded to ensure consistency and fidelity of the intervention protocol (Winstein et al., 2016).
研究组 & 干预措施
Combined Focus of Attention Group (CFAG)
Participants in the Combined Focus of Attention Group will receive a standardized rehabilitation program plus a task-specific upper extremity training session with combined internal and external attentional focus instructions. During each task (e.g., reaching, grasping, holding objects), participants will be instructed to focus simultaneously on body movements (internal focus, e.g., "feel your shoulder moving as you extend your arm") and movement effects on the environment (external focus, e.g., "focus on the target and guide your hand to touch it"). Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes (45 minutes standard rehab + 15 minutes attentional focus training), over four weeks.
干预措施: Combined Focus of Attention Instructions (Other)
Sequential Focus of Attention Group (SFAG)
Participants in the Sequential Focus of Attention Group will receive a standardized rehabilitation program plus a task-specific upper extremity training session with sequential attentional focus instructions. Internal focus cues (e.g., "feel your shoulder moving as you extend your arm") are provided during the first two weeks to enhance basic motor control, followed by external focus cues (e.g., "focus on the target and guide your hand to touch it") during the next two weeks to improve movement efficiency and functional performance. Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes (45 minutes standard rehab + 15 minutes attentional focus training), over four weeks.
干预措施: Sequential Focus of Attention Instructions (Other)
Control Group
Participants in the Control Group will receive the standardized rehabilitation program only, without any specific attentional focus instructions. The program includes task-oriented upper extremity exercises targeting range of motion, motor control, coordination, and functional performance. Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes, over four weeks.
干预措施: standart rehabilitation program (Other)
Combined Focus of Attention Group (CFAG)
Participants in the Combined Focus of Attention Group will receive a standardized rehabilitation program plus a task-specific upper extremity training session with combined internal and external attentional focus instructions. During each task (e.g., reaching, grasping, holding objects), participants will be instructed to focus simultaneously on body movements (internal focus, e.g., "feel your shoulder moving as you extend your arm") and movement effects on the environment (external focus, e.g., "focus on the target and guide your hand to touch it"). Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes (45 minutes standard rehab + 15 minutes attentional focus training), over four weeks.
干预措施: standart rehabilitation program (Other)
Sequential Focus of Attention Group (SFAG)
Participants in the Sequential Focus of Attention Group will receive a standardized rehabilitation program plus a task-specific upper extremity training session with sequential attentional focus instructions. Internal focus cues (e.g., "feel your shoulder moving as you extend your arm") are provided during the first two weeks to enhance basic motor control, followed by external focus cues (e.g., "focus on the target and guide your hand to touch it") during the next two weeks to improve movement efficiency and functional performance. Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes (45 minutes standard rehab + 15 minutes attentional focus training), over four weeks.
干预措施: standart rehabilitation program (Other)
结局指标
主要结局
Fugl Meyer Assessment- Upper Extremity Subscore
时间窗: baseline, four weeks after the baseline
The Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) is a validated scale used to evaluate motor control, coordination, and functional performance of the affected arm in stroke patients. Scores range from 0 to 66, with higher scores indicating better motor function.
次要结局
- Fugl-Meyer Assessment-Total Score(baseline, four weeks after the baseline)
- Action Research Arm Test(baseline, four weeks after the baseline)
- Wolf Motor Function Test(baseline, four weeks after the baseline)
研究者
Pelin Pişirici
Assistant Professor, PT, PhD
Bahçeşehir University
