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临床试验/CTRI/2025/06/088472
CTRI/2025/06/088472尚未招募不适用

Comparison of Intermittent Long-Term Constraint Induced Movement Therapy Protocol Versus Standard Motor Relearning Program for Upper Extremity Function in Patients with Stroke

DYPatil college of physiotherapy1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.Motor activity Log-28

研究概览

简要总结

The patients with stroke suffering from Middle cerebral artery infarct regain motor function in lower limb early and become ambulated. But upper limb functions remain limited causing difficulty in activities of daily living.

The two important interventions to improve upper extremity function are Constraint induced movement therapy and standard Motor relearning program.

The original form of Constraint induced movement therapy involves intensive graded practice of paretic upper extremity for 6 hours a day,5 days a week for 2 weeks (Edward Taub).

Further evidence shows about modified CIMT with less clinical hours and increased amount of time to be spent on home-based practice. A study by Mithil Shah et al (2016) had compared effects of CIMT with Motor relearning program where constraint was given  for 3 hours daily for 14 days.

This puts burden on family members / care givers for application of sling and influences the degree and completion of compliance. Therefore, there is a need to frame a revised protocol for CIMT.

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
40.00 Year(s) 至 70.00 Year(s)(—)

入选标准

  • All Genders
  • Age group 40 to 70 years
  • First incidence of stroke
  • 6th day post Stroke
  • Hemiplegia due to thromboembolus of Middle cerebral artery involvement confirmed on CT or MRI
  • Brunnstroms voluntary control of affected extremity Grade 2
  • Mini Mental Status Examination (MMES) score more than 24
  • Motor Activity Log scores more than 2
  • Patient having at least one care giver at home.

排除标准

  • Hemodynamically unstable patient
  • Patient who developed recurrent stroke during rehabilitation
  • History of traumatic and arthritic conditions interfering with upper extremity function
  • Patients with sensory Stroke
  • Patients who are unable to understand instructions and follow commands.

结局指标

主要结局

1.Motor activity Log-28

时间窗: Subjects will be evaluated 2 times-pretraining 1st week and post-training after 6 weeks

2.Nine Hole Peg Test

时间窗: Subjects will be evaluated 2 times-pretraining 1st week and post-training after 6 weeks

3.Fugl-Meyer Assessment Upper Extremity

时间窗: Subjects will be evaluated 2 times-pretraining 1st week and post-training after 6 weeks

4. Hand Dynamometer

时间窗: Subjects will be evaluated 2 times-pretraining 1st week and post-training after 6 weeks

次要结局

  • 1.Serum lactate level

研究者

发起方
DYPatil college of physiotherapy
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Amruta Dhondiram Doijad

D.Y.Patil College of Physiotherapy,Kolhapur

研究点 (1)

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