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临床试验/NCT05405140
NCT05405140已完成不适用

Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity

Riphah International University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Modified ashworh scale

研究概览

简要总结

this study will be conducted to f find the effects of multiphasic neuroplasticity based training protocol with Shock Wave Therapy on Neurophysiological, Morphological and Functional Parameters of Post Stroke Spasticity.

详细描述

Spasticity is a common sensory-motor dysfunction observed following a stroke. Spasticity is a velocity-dependent increase in resistance during a passive stretch due to hyper excitability of stretch reflex. This results in many functional impairments and patients centered problems. Given the complexity of spasticity related issues, its rehabilitation must entail comprehensive approach which address and synchronize spasticity reduction with motor function restoration without compensation. Shock Wave Therapy (SWT) is a non-invasive low cost devise gaining its use for spasticity reduction. After damage brain undergoes some sort of rearrangement. Literature says that during this period if it will rehabilitated through new pattern functional recovery can be optimized. However there is paucity of evidence for effectiveness of multiphasic neuroplasticity based Training protocol (MNTP) with SWT regarding its intensity frequency and specificity for spasticity management.

It will be a mix method approach. The patients after full filling the inclusion criteria , age ranging between 45 to 65 years having a stroke more than 3 months ago and having problematic spasticity interfering with function or causing a clinical problem, and no contraindications to shock wave therapy Upper or lower limb spasticity MAS ≥ 1 will be randomly assigned into four groups A,B,C,D. All groups will receive conventional rehabilitation training for 30 min per day five times a week for 4 weeks .Moreover patients in group A,BC also receive added SWT, MNTP and a combination of MNTP and SWT respectively. Motor recovery and spasticity will be using clinical (modified Asworth scale, Tardieu scale), neurophysiological, morphological(muscle ultrasound) and functional parameter( Fugl -meyer, burg balance, time up and go, Barthal index, Rivermeads mobility index ) at 0 , 8 and 16 week of treatment. The methodological approach used in this, will encompasses quantitative methods to assess program effectiveness and mixed methods to evaluate rehabilitation program components and aspects of protocol implementation. Qualitative methodology is needed to capture the range of participant experiences in the real- life clinical setting.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40 - 70years.
  • Those had a stroke more than 3 months ago
  • Unilateral stroke
  • Able to participate in therapy regime or Participate in an ambulatory rehabilitation program.
  • They having problematic spasticity either focal or generalized.
  • Upper or lower limb spasticity (MAS ≥ 2) interfering with function or causing a clinical problem, and no contraindications to shock wave therapy.
  • if the improvement in spasticity is realistically expected
  • they will be considered suitable for to shock wave therapy
  • Minimental scale examination (MMSE).
  • Comprehensive Severity Index (CSI) for severity assessment.

排除标准

  • If they had had received treatment with BoNT-A within six months
  • Will receiving intrathecal baclofen or other anti-spasticity medications
  • If patients will be on to anticoagulants.
  • had undergone neurolysis or surgery to the affected limb;
  • had concomitant neurological conditions

结局指标

主要结局

Modified ashworh scale

时间窗: 6th weeks

Modified Ashworth Scale (MAS) is used to assess spasticity. Scoring is between 0 to 4 where 0 means no increase in muscle tone and 4 means limb is rigid in flexion or extension.

次要结局

  • EMG study(6th weeks)
  • Resting joint angle(6th weeks)
  • Ultrasonography(6th weeks)
  • Time up and Go(6th weeks)
  • Rivermead Mobility Index(6 week)
  • Burg Balance scale(6th weeks)
  • Functional independence measure(6th weeks)
  • Barthal index(6th weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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