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临床试验/CTRI/2025/11/097225
CTRI/2025/11/097225招募中不适用

To compare the effectiveness of Arm Ability Training with rhythmic auditory stimulation Versus Task Oriented Training with Rhythmic Auditory Stimulation to improve upper limb dexterity and quality of life in sub-acute stroke patients

The Tn Dr MGR Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Modified Standardized Nine hole peg test for assessing dexterity:

研究概览

简要总结

Stroke is the most common cause of long-term disability. In about 70–80% of stroke patients, upper limb (UL) impairment is present. However, it is crucial to improve the use of the affected upper limb because having difficulty in performing daily activities is associated with reduced quality of life. [1] However, both task-oriented training and arm ability training with rhythmic auditory stimulation are believed to enhance the functional recovery of the upper limb by improving upper limb dexterity and quality of life. A randomized study is performed after appropriate ethical clearance and consent by the concerned authorities, as well as patients to conduct the study. A total of 50 participants were recruited for the study based on inclusion and exclusion criteria. All the participants were randomly divided into 2 groups, where Group A received task-oriented training with rhythmic auditory stimulation and Group B received arm ability training with rhythmic auditory stimulation. Both groups received treatment for up to 45 minutes, 2 sets with 2-3 minutes of rest, followed by every 15 minutes of continuous training and 5 days per week for up to 3 & 4 weeks. Individuals were assessed using the outcome measures, Fugl-Meyer Assessment Upper Extremity (FMA-UE), Stroke quality of life scale (SQOL) and Modified Standardized Nine -Hole peg test (mS-NHPT) before the treatment and after three & four weeks post-treatment

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 and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Middle cerebral artery infarct Hemiplegic patients Post stroke from 2 months to 1 year Voluntary control grading from grade 2-5 Brunnstorm stages of recovery from 3-6 Mini mental state of examination score more than 24.

排除标准

  • Visual deficit Auditory deficit Cognitive impairment Perceptual disorders Contracture of upper limb Dementia Uncontrolled hypertension NPRS 7-10(severe) Shoulder subluxation /dislocation.

结局指标

主要结局

Modified Standardized Nine hole peg test for assessing dexterity:

时间窗: 4 weeks

次要结局

  • Fugl-Meyer Assessment for upper extremity

研究者

发起方
The Tn Dr MGR Medical University
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

D Mythili

Saveetha Institute of Medical and Technical Sciences

研究点 (1)

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