Effects Of Conventional Physical Therapy With And Without Action Observation Therapy On Freezing Of Gait And Functional Mobility In Participants With Parkinson's Disease: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in functional mobility
研究概览
简要总结
The goal of this study is to determine the effects of action observation therapy with conventional physical therapy on freezing gait and functional limitation in participants with Parkinson's disease.
详细描述
Parkinson's disease is a neurodegenerative disorder that is characterized by rigidity, tremors, and bradykinesia, along with non-motor dysfunction. The exercise rehabilitation has a positive impact on motor and non-motor functions in individuals with Parkinson's disease. Conventional physical therapy (CPT) that involves isometric exercises, stretching techniques, and strength and balance training is useful to improve the severity of functional mobility and freezing of gait. In action observation therapy (AOT), small video clips of different goal-directed tasks were added to rehabilitation to determine the combined effects on outcome.
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
This study will use a single-blind masking design, in which the outcome assessor will be blinded to group allocation. Participants and therapists will be aware of the intervention assigned, but the assessor responsible for data collection and analysis will not have access to group assignment information to minimize assessment bias.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants were included based on the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with clinical findings supporting the diagnosis. The eligible participants were
- •Aged between 50 and 80 years,
- •Both genders,
- •UK Parkinson's Disease Society Brain Bank diagnostic criteria, labelled as stage ≤ 3,
- •with a minimum of 2 years since being diagnosed with PD and
- •Freezing of gait score of 9 or higher on FOG-Q
- •Able to understand and follow commands.
排除标准
- •The exclusion criteria were
- •systemic diseases such as diabetes, sepsis, systemic lupus erythematosus
- •Uncontrolled hypertension or hypotension
- •2. neurological issues that could affect the assessment and outcomes of treatment,
- •implantation for deep brain stimulation
- •visual or acoustic limitations.
研究组 & 干预措施
Experimental Group
This group included action observation therapy in addition to conventional physical therapy, in which small videos containing specific task will be made available to follow to the participants.
干预措施: Action Observation plus conventional Physical Therapy (Other)
Conventional Physiotherapy Group
This group included conventional physical therapy that contains isometric exercise, stretching techniques, and strength and balance training.
干预措施: Conventional Physical Therapy (Other)
结局指标
主要结局
Change in functional mobility
时间窗: The assessment was made at baseline before the treatment session, and any change in mobility status was observed at the end of 6th week and 12th week after the intervention.
The TUG is an efficient test that measures mobility and balance, requiring participants to rise from a chair, walk 3 meters, turn, walk back, and sit down. The time taken to complete this sequence is recorded, with longer times indicating potential mobility issues. A score of more than or equal to fourteen seconds indicates a high risk of falls.
Change in Freezing of gait
时间窗: The freezing of gait was assessed at baseline, and any change in it was measured at the end of 6th week and 12th week after the intervention.
The FOG-Q is a reliable tool for evaluating the effectiveness of treatment intervention on FOG for Parkinson's disease. The questionnaire consists of 6 items designed to assess the severity of freezing of gait. Each item is rated on a five-point Likert scale, with '0' indicating no symptoms and '4' indicating the most severe symptoms. The total score can range from 0 to 24, with higher scores indicating greater severity of freezing of gait.
Change in functional mobility
时间窗: The assessment was made at baseline before the treatment session, and any change in mobility status was observed at the end of 6th week and 12th week after the intervention.
The TUG is an efficient test that measures mobility and balance, requiring participants to rise from a chair, walk 3 meters, turn, walk back, and sit down. The time taken to complete this sequence is recorded, with longer times indicating potential mobility issues. A score of more than or equal to fourteen seconds indicates a high risk of falls.
Change in Freezing of gait
时间窗: The freezing of gait was assessed at baseline, and any change in it was measured at the end of 6th week and 12th week after the intervention.
The FOG-Q is a reliable tool for evaluating the effectiveness of treatment intervention on FOG for Parkinson's disease. The questionnaire consists of 6 items designed to assess the severity of freezing of gait. Each item is rated on a five-point Likert scale, with '0' indicating no symptoms and '4' indicating the most severe symptoms. The total score can range from 0 to 24, with higher scores indicating greater severity of freezing of gait.
次要结局
未报告次要终点