Evaluation of the Ronnie Gardiner Method in Individuals With Stroke in Late Phase of Recovery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Balance performance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest)
研究概览
简要总结
Stroke is a common condition that often leads to long-term disabilities, significantly affecting individuals' quality of life and imposing substantial societal costs. There is growing evidence that physical rehabilitation can improve motor function, well-being, and quality of life even in the chronic phase after stroke. In recent years, rhythm- and music-based interventions have gained increasing attention as promising tools in neurorehabilitation. The Ronnie Gardiner Method (RGM) is a structured, music-based training method that engages motor, sensory, cognitive, and emotional functions simultaneously. While preliminary studies have shown positive effects of RGM in individuals with Parkinson's disease, there is limited research on its impact in stroke rehabilitation, particularly in the chronic phase.
This randomized controlled multicenter study aims to evaluate the effects of RGM training in individuals aged 18 and older who are more than six months post-stroke. Participants will be randomly assigned to either an intervention group receiving RGM training twice per week for 12 weeks, or to a passive control group. The primary outcome is balance, assessed by the Mini-BESTest. Secondary outcomes include gait, upper limb function, cognitive abilities such as working memory and divided attention, and health-related quality of life. Additionally, qualitative data will be collected to explore participants' and trainers' experiences regarding motivation, engagement, and perceived impact on daily participation. The study is expected to provide valuable evidence on the clinical usefulness of RGM in chronic stroke rehabilitation and its potential to be implemented as part of community-based, cost-effective rehabilitation programs.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group allocation. Neither participants nor intervention providers will be masked due to the nature of the intervention.
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
- •Community-dwelling individuals with stroke that occurred > 6 months ago
- •Cognitive ability corresponding to at least 25 out of 30 points on the Montreal Cognitive Assessment (MoCA)
- •Functional disability corresponding to a Modified Rankin Scale (mRS) score of 2-3
- •No assistance required for daily activities during participation (e.g., can independently travel to measurement/training sites and use the restroom)
- •Ability to stand for 2 minutes without support and walk 10 meters with or without assistive devices, but without supervision
排除标准
- •Severe visual and/or hearing impairments that would interfere with study participation
- •Participation in regular sessions with RGM after August 2024
- •Previous experience playing a musical instrument (defined as practicing >1 hour/week in the past 10 years)
- •A score of less than 25 on the Montreal Cognitive Assessment (MoCA)
研究组 & 干预措施
Music-based intervention
Participants randomized to the intervention group will receive the Ronnie Gardiner Method (RGM), a rhythm- and music-based training program, in group sessions led by a certified instructor. The intervention consists of 60-minute sessions, twice per week, for 12 consecutive weeks. The training incorporates coordinated movements, speech, and rhythm using visual symbols representing limbs and directions, performed to music with varying tempo and complexity. Exercises are designed to improve motor function, balance, coordination, and cognitive engagement. Sessions are conducted primarily in standing to optimize balance effects.
干预措施: The Ronnie Gardiner Method (Behavioral)
Waiting-list
Waiting list, receiving the same intervention after the final follow-up assessment three months post-intervention.
结局指标
主要结局
Balance performance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest)
时间窗: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
The mini-BESTest (Mini Balance Evaluation Systems Test) is a shortened version of the BESTest, designed to assess balance and functional mobility, especially in individuals with neurological or musculoskeletal conditions. It focuses on balance deficits across domains like postural control, gait, stability, and anticipatory responses. With 14 items compared to the original 36, the mini-BESTest is quicker to administer, making it more practical for clinical use. It evaluates four main balance systems: * Anticipatory Postural Adjustments: Preparing and adjusting posture for movements. * Reactive Postural Control: Responding to unexpected balance challenges. * Sensory Orientation: Using sensory input (like vision and proprioception) for balance. * Dynamic Gait: Stability and efficiency while walking, including maintaining balance during movement. Minimum score is 0 points, maximum score is 28 points. Higher scores indicate better balance control.
次要结局
- Concern about falling measured by the Falls Efficacy Scale-International (FES-I)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Working memory measured by the Memory Test (Immediate and Delayed Recall)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Cognitive flexibility and inhibitory control measured by the Victoria Stroop Test(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Visuospatial memory and organization measured by the Rey-Osterrieth Complex Figure Test(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Physical performance measured by the Short Physical Performance Battery (SPPB)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Functional mobility and gait performance measured by the 10-Meter Walk Test (10MWT)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Physical capacity including aerobic capacity and endurance measured by the 6-Minute Walk Test (6MWT)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Upper extremity function measured by The Observational Drinking Task Assessment(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Finger dexterity and fine motor skills measures by the 9-Hole Peg Test (9HPT)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Health-related quality of life and functional recovery after a stroke measured by the Stroke Impact Scale 16 (SIS-16)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Severity of depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- General health-realted quality of life measured by the Research and development (RAND) 36-item health survey(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))
- Cost-effectiveness evaluated with the standardized European Quality of Life (EuroQol) questionnaire with 5 dimensions(At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up))