Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Activities-specific Balance Confidence Scale (ABC):
研究概览
简要总结
The Objective of this research was to study the effectiveness of sensory integration training on balance and confidence in patients with Parkinson's disease.
Null Hypothesis:
Sensory integration training and conventional balance training have no significant difference in improving balance and confidence of patients with Parkinson's disease.
Alternative Hypothesis:
Sensory integration training and conventional balance training have a significant difference in improving balance and confidence in patients with Parkinson's disease.
详细描述
The study design will be randomized controlled clinical trial. Patients who fulfill the inclusion criteria will be identified by individual physiotherapist and will be enrolled for particular study. A sample size of 46 patients will be taken in this study by expecting a mean change 10.42 using 80% power of study and 95% level of significance and 20% dropout will also be included. So each group contains 23 participants.
The study will be single blinded. The outcome assessor will be unaware of the treatment given to both groups. Sample will be collected through simple random sampling technique, and randomization sequencing will be generated with help of lottery. After selection the sample patients will be divided into two groups, allocation concealment will be ensured by using sealed envelopes. Group A will be given conventional balance training along with routine physical therapy without sensory integration and Group B will be given sensory integration physical therapy along with routine physical therapy. Group A will be called control group and Group B will be called experimental group. Every patient has to pick up an envelope which will be placed in patient's file which later will be opened by the researcher who will provide patient treatment accordingly.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients diagnosed by a neurologist with Parkinson's disease.
- •Patients having BBS score between 21-40
- •At least 6 months post neurological Sensory/Motor deficit patient.
- •Age between 30 -65 years.
- •Ability to maintain standing position without aids for at least 5 minutes.
- •Normal vision
- •No severe systemic disorders
- •An ability to understand and perform the test
排除标准
- •Patients with other existing neuromuscular disorders or medical conditions that substantially influences their gait and balance performance
- •Neuropathy patients
- •Vestibular disorders, paroxysmal vertigo.
- •Presence of orthopedic conditions involving the lower limbs.
- •Patients with psychiatric disorders.
- •Pregnant patients.
结局指标
主要结局
Activities-specific Balance Confidence Scale (ABC):
时间窗: the change in the ability to balance in individual at baseline, 6th and 12th week
This validated and reliable self-reported measure evaluates the patient's perceived level of balance confidence in performing various ambulatory activities without falling or experiencing a sense of instability. The overall score is calculated by adding the item scores and then dividing by the total number of items (score range, 0-100 points per activity; higher=more confident.
Berg Balance Scale (BBS):
时间窗: the change in the ability to balance in individual at baseline, 6th and 12th week
The BBS is a 14-item validated scale that assesses static and dynamic Balance disorders in individuals with Parkinson's disease (score range, 0-56; higher=better performance). The items explore the ability to sit, stand, lean, turn, and maintain the upright position on one leg. Performance of these tasks depends on central integration processes to select specific response strategies which, in turn, depend on the characteristics of external postural displacement and goals
次要结局
未报告次要终点