Designing, Developing and Testing of an innovative device for calf muscle flexibility and relaxation- A Multiphasic Exploratory Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Numeric Pain Rating Scale
研究概览
简要总结
Title : Designing, Developing and Testing of an Innovative Device For Calf Muscle Flexibility and Relaxation : A Multiphasic Exploratory Device
Investigators : Delvadiya Priya Dayabhai; PT, Dr. Komal Doshi; MPT, School of Physiotherapy, RK University.
Background : The calf muscle namely, gastrocnemius and soleus muscles plays a crucial role in facilitating planter flexion of the foot, essential for various locomotor activities. Insufficient calf muscle flexibility can result in reduce performance, increase risk injury and persistent pain and it commonly affects people with sedentary lifestyle, overuse of calf muscle activities and individuals with condition like planter fascitis and achiilies tendinitis. Conservative treatment for flexibility and relaxation such manual stretching, foam roller, massage gun etc. This clinical trail aim to assess the feasibility and effectiveness of innovative device which is designed for calf flexibility and relaxation by stretching combining with vibration in to one device, cost effective.
Method : Following ethical approval, 60 subjects will be selected as per inclusion criteria and will receive innovative device. Outcome will be assess before treatment ( baseline) and post treatment after 1 week with Numeric Pain Rating Scale and ankle range of motion.
The study is divided into 3 phases:
Phase 1: Designing of an innovative device for calf muscle flexibility and relaxation.
Phase 2: Developing of an innovative device for calf muscle flexibility and relaxation.
Phase 3: Determine feasibility and effectiveness of an innovative device for calf muscle flexibility and relaxation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Calf Pain with Calf Muscle Tightness 2) Silfverskiold Test Positive.
排除标准
- •Lower Limb Fractures 2) Tendon ruptures of Lower Limb 3) Osteoarthritis of Knee 4) Nerve injury of Lower Limb 5) Previous surgeries of Lower Limb 6) Not willing to sign informed consent.
结局指标
主要结局
1) Numeric Pain Rating Scale
时间窗: Pre outcome at baseline (first day of training) | Post outcome after 1 week(last day of training)
2) Ankle Dorsiflexion Range of Motion
时间窗: Pre outcome at baseline (first day of training) | Post outcome after 1 week(last day of training)
3) QUEST 2.0 Scale
时间窗: Pre outcome at baseline (first day of training) | Post outcome after 1 week(last day of training)
次要结局
- Not Applicable(Not Applicable)
研究者
Delvadiya Priya Dayabhai
School of Physiotherapy, RK University