Combined Effects of Transcranial Direct Current Stimulation and Oral Baclofen on Spasticity and Motor Function in Patients with Spastic Hemiplegia: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
This Randomized placebo controlled interventional trail aims to evaluate the combined effect of transcranial direct current stimulation (tDCS) and oral Baclofen on spasticity and motor function in individuals with post -stroke spastic hemiplegia. Stroke is a major cause of long-term disability and spasticity significantly limits functional recovery and quality of life. Participants diagnosed with spastic hemiplegia following stroke will be randomly assigned to two groups. The experimental group will receive real tDCS, oral Baclofen, and conventional physiotherapy, while the control group will receive sham (placebo) tDCS along with conventional physiotherapy. The interventions will be administered over a period of 2 weeks. Primary outcome measures will include changes in spasticity assessed by the Modified Ashworth scale and motor function assessed by the Fugl-Meyer Assessment. Secondary outcomes will include Stroke impact scale. This study intends to investigate whether the combination of non invasive brain stimulation and pharmacological treatment provides superior outcomes compared to physiotherapy alone in managing post stroke spasticity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with : All genders between the age group of 18 to 65 years of age, Who are willing to participate Diagnosed with first time stroke Ischemic or Hemorrhagic (more than 3months) Spasticity more than 1 plus according to Modified Ashworth Scale in atleast one major upper or lower limb muscle.
- •Consciousness able to follow verbal commands & no hearing disability No other associated traumatic and non traumatic disorder of neurological, musculoskeletal and cardiac system.
排除标准
- •Subjects with Severe cognitive impairment Known Allergy or intolerance to Oral Baclofen drug Pregnancy or lactation Sensory disturbances History of seizures or epilepsy Presence of metal implants or electronic devices ( eg: pacemaker, cochlear implants) Currently receiving other spasticity reducing treatment (eg: botulinum toxin , intrathecal baclofen) Other unstable medical conditions.
结局指标
主要结局
Modified Ashworth Scale
时间窗: Modified Ashworth Scale to assess spasticity pre and post 2 week intervention | Fugl meyer assessment Scale | is used to assess motor function pre and post intervention
Fugl meyer assessment Scale
时间窗: Modified Ashworth Scale to assess spasticity pre and post 2 week intervention | Fugl meyer assessment Scale | is used to assess motor function pre and post intervention
次要结局
- Stroke Impact Scale(Stroke Impact scale assesses physical function , emotion , memory, communication and social participation in stroke survivors pre and post intervention.)
研究者
Dr Raghavendrasingh Dharwadkar
KAHER Institute of Physiotherapy