Effects of Augmented Reality Functional Integrated Training (AR-FIT) on Balance and Mobility in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
The present study aims to develop and validate an evidence-based functional balance task library for Augmented Reality-Functional Integrated Training (AR-FIT), incorporating standardized real-object integration through expert consensus and pilot usability testing. Furthermore, the study seeks to determine the effects of AR-FIT on balance and functional mobility in stroke survivors in comparison to conventional Augmented Reality & task oriented training over an eight-week intervention period. In addition, it intends to evaluate participant motivation, engagement, and perceived task realism during AR-FIT using structured questionnaires and post-intervention interviews, thereby examining both clinical effectiveness and user-centered experience outcomes.
详细描述
Stroke remains a leading cause of long-term disability, with its burden rising sharply in low- and middle-income countries such as Pakistan. Despite advances in acute care, many survivors continue to experience persistent balance and mobility impairments that limit independence. While augmented reality (AR) based rehabilitation has shown promise in improving motor recovery and engagement, current AR systems often emphasize generalized or gamified tasks, offering limited opportunities for practicing functionally relevant, real-world movements. Therefore, the current study introduces an Augmented Reality-Functional Interactive Training (AR-FIT), designed to evaluate the feasibility and effectiveness of combining AR-guided feedback with real-object manipulation for post-stroke balance training. The objectives are threefold: first, to determine the feasibility and usability of AR-FIT as a balance training platform; second, to assess its impact on postural control, balance, and functional mobility compared to conventional AR training; and third, to explore patient motivation and engagement associated with tangible, ecologically valid tasks. By enhancing realism, sensory engagement, and functional relevance, this approach is expected to bridge the existing gap between digital rehabilitation technologies and the real-world 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)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40-70 years with first-ever ischemic or hemorrhagic stroke (>3 months post-onset).
- •Cognitive ability: MMSE >
- •No or mild spasticity in upper/lower limb MAS ≤ 2
- •Functional Ambulation Category (FAC) ≥
- •Berg Balance Scale (BBS) 20-40 (to avoid floor/ceiling effects).
- •Ability to walk 10 meters independently
- •Willingness to provide informed consent and participate regularly.
排除标准
- •Severe musculoskeletal or neurological comorbidities (e.g., contractures, Parkinson's disease).
- •Severe visual, neglect, or communication impairments.
- •Uncontrolled systemic illness or unstable cardiovascular condition.
- •Participation in another interventional trial within the last 3 months.
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Berg Balance Scale (BBS) is a widely used performance-based clinical measure for assessing functional balance in individuals with neurological conditions, including stroke. It consists of 14 tasks that evaluate static and dynamic balance abilities during common functional activities such as sitting, standing, reaching, turning, and transfers. Each item is scored on a 5-point ordinal scale ranging from 0 (unable to perform) to 4 (independent performance), with a maximum total score of 56 indicating better balance performance. The BBS demonstrates strong validity and high inter-rater and test-retest reliability and is commonly used to assess balance impairment and monitor rehabilitation outcomes in stroke populations.
Timed Up & Go (TUG)
时间窗: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Timed Up and Go Test (TUG) is a simple and widely used clinical test for assessing functional mobility and dynamic balance. The test measures the time (in seconds) required for an individual to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Shorter completion times indicate better functional mobility. Typical interpretation suggests that \<10 seconds represents normal mobility, 10-20 seconds indicates variable mobility, and ≥14 seconds is commonly considered a threshold for increased fall risk in individuals with stroke. The TUG has demonstrated strong test-retest and inter-rater reliability in stroke populations and is frequently used in rehabilitation research to evaluate mobility and fall risk. Instrumented versions of the TUG (iTUG) have also shown improved predictive capabilities and good psychometric properties.
Balance Evaluation Systems Test (Mini-BESTest)
时间窗: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Mini-BESTest (Mini Balance Evaluation Systems Test) is a performance-based clinical assessment used to evaluate dynamic balance and postural control. It assesses four key balance control systems: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The test consists of 14 items scored on a 3-point ordinal scale (0-2), with a maximum score of 28 indicating better balance performance. The Mini-BESTest has demonstrated good construct validity and excellent inter-rater and test-retest reliability in individuals with neurological conditions, including stroke, and is widely used to assess balance impairments and monitor rehabilitation outcomes.
FUGL Meyer (Lower limb)
时间窗: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Lower Extremity component of the Fugl-Meyer Assessment Lower Extremity (FMA-LE) is a stroke-specific, performance-based clinical assessment used to evaluate motor recovery of the lower limb following stroke. It measures key domains including voluntary movement within and out of synergy patterns, coordination, and reflex activity. The scale consists of multiple items scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 34 indicating better lower extremity motor function. The instrument demonstrates strong construct validity and excellent reliability (r ≈ 0.99) for assessing post-stroke motor impairment and is widely used in clinical and research settings to monitor motor recovery and treatment outcomes.
次要结局
- User Engagement Questionnaire (UEQ)(8 Weeks)
- Stroke Impact Scale (SIS v3.0)(Baseline-4 Weeks-8 Week-3 Months Follow Up)