Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- The Freezing of Gait Questionnaire (FOGQ) (to access the change in freezing of gait in individuals at baseline, 6th and 12th week.)
研究概览
简要总结
Objective of this study is to compare the effectiveness of routine physical therapy with and without Proprioceptive Neuromuscular Facilitation on Balance, gait and function in patients with Parkinson's disease.
Alternate hypothesis:
There will be a difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.
Null hypothesis:
There will be no difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.
详细描述
It will be a prospectively registered, parallel designed, single blinded randomized controlled trial with concealed allocation, conducted in University of Lahore Teaching Hospital and Sir Ganga Raam hospital, Lahore, Pakistan. Patients who met eligibility criteria will be informed about the aim of study.consent form will be signed by all eligible participants. Eligibility of participants will be confirmed by the physiotherapist of research team before randomization. After baseline assessment, eligible patients will be randomly allocated(in a 1:! ratio) in two groups( group A and group B). Fish bowl method of randomization will be used and will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis.
Randomization assignments will be kept in opaque, sealed envelopes for concealment of group allocation and will be unsealed by researcher after baseline testing. Researchers who assess outcomes or will do data analyses will be masked to group allocation.The calculated sample size is 32 (16 in each group), after adding 20% dropout the sample size will be 32+6=38, 19 patients in each group.(statistical power 80% and alpha level of 5%).
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of age between 60 and 85 years, diagnosed with Parkinson's disease by a neurologist.
- •Patients with Hoehn and Yahr stages 1-
- •Patients with a stable drug program and acclimated to their current medication use for at least 2 weeks.
排除标准
- •Cognitive deficits (scores of <26 on the Mini-Mental State Examination).
- •Moderate or severe depression (scores of >17 on the Beck Depression Inventory).
- •Patients with neurological diseases, arthrosis, or total hip joint replacement.
结局指标
主要结局
The Freezing of Gait Questionnaire (FOGQ) (to access the change in freezing of gait in individuals at baseline, 6th and 12th week.)
时间窗: the change in freezing of gait in individuals at baseline, 6th and 12th week
It is used to assess freezing of gait severity in patients with Parkinson's disease. It consists of a 6-item questionnaire. A 5-point scale is used to mark scores. Zero (absence of symptoms) to 4 (most severe), is used for each item to rank severity of symptoms.
Berg balance scale (BBS) (to access the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.)
时间窗: the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.
It is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks. It consist of a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task. Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.
Functional Independence Measure (FIM) (to assess the change in ability to do activities of daily living at baseline, 6th and 12th week.)
时间窗: the change in ability to do activities of daily living at baseline, 6th and 12th week
It is used to assess the ability of patients to do activities of daily living. It consist of 18-item, clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication, and cognition. Total score for FIM will be a value between 18 and 126. Higher the score, more independent the patient is.
次要结局
未报告次要终点