Comparative efficacy of various Constraint-Induced Movement Therapy techniques for lower extremity function in subject with stroke: a randomised clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Balance: Berg Balance Scale (BBS)
研究概览
简要总结
SUMMARY:
Balance and gait impairment following a stroke is a very common cause of long-term disability worldwide. At least 50% of post-stroke subjects are unable to do activities of daily living (ADL) independently. More than 80% of post-stroke subjects suffer from gait disturbance that regains to some extent in the first 3-6 months following the stroke. But community ambulation is still jeopardized. Walking ability is an important predictor for good quality of life and functional independence following a stroke. Reclaiming walking ability is the most important goal for post-stroke subjects. Various approaches are implemented in physiotherapy to regain the functional mobility of subjects with stroke. Modified constraint-induced movement therapy(m-CIMT) exerts a wonderful effect on enhancing motor recovery by improving neural plasticity.
Purpose of the study
Purpose of the study to find out the efficacy of various modified constraint-induced movement therapy (m-CIMT) techniques for lower extremity function in patients with stroke.
Objectives
To determine the efficacy of various modified constraint-induced movement therapy (mCIMT) techniques for lower extremity function in stroke patient and to compare the effect of these 3 different techniques.
Material and methods
Post-stroke subjects will be chosen based on the inclusion and exclusion criteria. Subjects will be randomly divided into three groups (n=12) to compare the efficacy of various modified constraint-induced movement therapy (m-CIMT) techniques for lower extremity function in patients with stroke. Group A, B, and C will receive the same exercise protocol with different restraining techniques. Treatment will be provided for 120 minutes per session, 5 days a week for a total of 2 weeks.
To immobilize the unaffected limb group A will be using an ankle mass in the nonparetic limb, group B will put on full leg orthosis during the exercise program. But group C will be asked to keep their non-paretic hip and knee in full extension with their foot flat.
Post intervention data will be obtained after 2 weeks of intervention.
Analysis:
Data analysis will be done by using SPSS 25 . Anova will be used to perform the data analysis between the groups and paired T test will be used for within group data analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject with mild to moderate disability according to Brunnstrom Recovery stages between ≥ III
- •Good cognitive ability (Mini-Mental status examinationscore≥24)
- •Subject able to stand and walk with minimal assistance
- •Subjects with cerebral stroke.
排除标准
- •History of Unstable cardiac conditions Other adverse medical conditions affecting balance, gait, pain, or any kind of discomfort that can interfere with the completion of the training
- •Subjects having tightness contracture and deformity
- •Berg Balance scale score ≤35.
结局指标
主要结局
Balance: Berg Balance Scale (BBS)
时间窗: 2 years
Gait : Dynamic Gait Index (DGI)
时间窗: 2 years
Functional mobility : Fugl-Meyer Assessment of Motor Recovery of Lower
时间窗: 2 years
Extremity (FMA-LE)
时间窗: 2 years
次要结局
- Quality of life- stroke specific quality of life. (SSQOL)(2 years)
研究者
Suparna Bandyopadhyaya
West Bengal University of Health Sciences(WBUHS)