跳至主要内容
临床试验/CTRI/2025/08/093859
CTRI/2025/08/093859尚未招募1 期

Effectiveness of Soft Robotic Glove Therapy with Mental Imagery versus Physical practice with Mental Imagery on post-stroke hand recovery- A comparative study.

Indian Spinal Injuries Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月8日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Fugl Meyer assessment upper extremity,

研究概览

简要总结

Stroke is a leading cause of long term disability, with many survivors experiencing persistent sequelae that impair hand function and limit independence in activities of daily living (ADLs). Mental imagery is the mental rehearsal of a physical task to enhance motor skills without actual movement. As it activates brain areas similar to physical practice, their combination effectively improves motor recovery after stroke. Stroke patients with hand impairments reported positive outcomes using a soft robotic glove. These gloves significantly improved strength, coordination, and dexterity, helping patients regain independence and serving as a promising adjunct in hand rehabilitation. While robotic gloves offer significant motor recovery benefits, they may not always outperform conventional physical practice. However, integrating them with mental imagery can further enhance functional improvement. This study would compare soft robotic glove with mental imagery to physical practice with mental imagery for post-stroke hand recovery, aiming to identify the more effective approach for better clinical outcomes. The study design will be Experimental and 30 participants will be recruited from PMR department, ISIC, New- Delhi. The participants age will be between 18 to 80 years, duration of more than 4 weeks post stroke, with MAS score of less than or equal to 2 for affected hand, ability to follow and understand commands and ability to imagine motor acts with KVIQ10 score of greater than or equal to 25. The exclusion criteria will be individuals having any pre diagnosed neurological and psychiatric disorder other than stroke. Individuals who have joint contracture, musculoskeletal pain or fracture in hand or wrist and individuals with perceptual deficits such as neglect and apraxia. Pre intervention assessment will be done using Fugl meyer assessment upper extremity, box and block test and Jebsen Taylor hand function test. Participants will then be divided into two groups (Group A and Group B) with 15 participants in each group. Group A will receive Mental imagery + Physical practice and Group B will receive Mental imagery + Soft robotic glove based therapy. The training program will be given for 35 mins, 3 sessions per week for 4 weeks. The post intervention assessment will be done after 4 weeks of intervention using the same outcome measures i.e. Fugl meyer assessment upper extremity, box and block test and Jebsen Taylor hand function test.

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 80.00 Year(s)(—)
性别
All

入选标准

  • Stroke duration of more than 4 weeks.
  • MOCA score of greater than or equal to 26 for good cognitive health.
  • Ability to imagine motor acts; completion of Kinesthetic and visual imagery questionnaire 10 with score of more than or equal to
  • Modified Ashworth Scale score of less than or equal to 2 for the affected hand.
  • Fugl Meyer Assessment- Upper Extremity score of greater than or equal to 50.

排除标准

  • Any pre diagnosed neurological and psychiatric disorder other than stroke.
  • Individuals who have joint contracture, musculoskeletal pain or fracture in hand or wrist.
  • Individuals with perceptual deficits such as neglect and apraxia.

结局指标

主要结局

Fugl Meyer assessment upper extremity,

时间窗: one Day before intervention and a day after 4 weeks of intervention.

Box and Block test, and

时间窗: one Day before intervention and a day after 4 weeks of intervention.

Jebsen Taylor Hand function test.

时间窗: one Day before intervention and a day after 4 weeks of intervention.

次要结局

  • NA(NA)

研究者

发起方
Indian Spinal Injuries Center
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ritika Chauhan

ISIC Institute of Rehabilitation sciences

研究点 (1)

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