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临床试验/CTRI/2025/03/081574
CTRI/2025/03/081574尚未招募不适用

Effects Of Soft Robotic Hand Glove Training On Hand Function In Patients With Sub acute Stroke:An Experimental Study

Maharashtra Institute of physiotherapy Latur1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2025年3月26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
43
试验地点
1
主要终点
1)Action Research Arm Test

研究概览

简要总结

Subjects will be screened as per the inclusion and exclusion criteria. Aim, objectives & treatment procedure will be explained to the participants. written and informed consent will be taken. Then subjects will be randomly allocated into two groups Group A (Experimental Group) & Group B (control Group). Necessary data will be taken from participants on a data collection sheet. 

GROUP A – Will include 22 participants receiving 30 minutes of soft robotic hand glove training for 3 days / week for 6 weeks. Along with conventional therapy. In soft robotic hand glove, there are 3 modes.

1-passive training mode the rehabilitation glove can drive the affected hand to execute flexion, extension exercise.

2.mirror training – under the exercise of mirror training with the help of robotic glove, the healthy hand drives the affected hand to move synchronously.

3.interactive game training - multi-interactive hand and brain combined games enhance the immersion of hand rehabilitation. Patients can also adjust the difficult of the game according to hand movements. Each mode will be given for 10 minutes.

Group A will also receive conventional physiotherapy treatment which is electrical muscle stimulator modality will be used on wrist extensor muscles and lumbricals. Dosage will be 35-50 pps pulse frequency,150 – 200 pulse duration, amplitude – sufficient for functional activity, ON and OFF time = 1:3 ratio,10 – 20 reps for 2 set for wrist extensor and lumbricals.

GROUP B – will include 22 participants receiving conventional therapy. Conventional therapy – electrical muscle stimulator modality will be used on wrist extensor muscles and lumbricals. Dosage will be 35-50 pps pulse frequency,150 – 200 pulse duration, amplitude – sufficient for functional activity, ON and OFF time = 1:3 ratio,10 – 20 reps for 2 set for wrist extensor and lumbricals. Patients will be assessed before , at the end of 3rdweek and at the end of 6 week with ACTION RESEARCH ARM TEST scale and Brunnstrom stage of recovery for hand as outcome.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
55.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subacute stroke subjects both male and female between age group of 55 to 70 years.
  • Brunnstrom stage of hand recovery from grade 2 and above.
  • Hemorrhagic stroke and ischemic stroke.
  • Subjects with no cognitive impairment, mini mental status examination score (MMSE) more than 24.

排除标准

  • Recent surgery or trauma of head, neck and upper extremity.
  • Subjects diagnosed with mental disorders.
  • Contracture of hand.
  • Subjects with impairment of sight, hearing and comprehension.

结局指标

主要结局

1)Action Research Arm Test

时间窗: At pre, 3rd week and 6th week

次要结局

  • 1)Brunnstrom stage of hand recovery.(At pre, 3rd week and 6th week)

研究者

发起方
Maharashtra Institute of physiotherapy Latur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Aditi Ashokkumar Devangare

Maharashtra Institute of physiotherapy Latur

研究点 (1)

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