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临床试验/CTRI/2024/07/069788
CTRI/2024/07/069788已完成2 期

Effectiveness of Arm Ability Training versus Task Oriented Training on upper limb function and quality of life for Sub Acute stroke subjects.

Mythili D1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
135
试验地点
1
主要终点
1. Graded Wolf Motor Function Test (gWMFT)

研究概览

简要总结

This Study is a Single blinded randomized controlled trail to find the effectiveness of Arm Ability Training versus Task Oriented training on Upper limb function and Quality of life for sub-acute stroke subjects.

Data samples will be collected from out patient department of Jaya college of Paramedical sciences, college of Physiotherapy, Thiruninravur.

The baseline data regarding name, age, sex, stroke duration, the side of involvement, MMSE and Brunnstorm recovery stage was taken after informed consent for all subjects.

135 stroke subjects randomly allocated as Group A (Conventional Group): 45 subjects Group B (Arm Ability Training): 45 Subjects Group C (Task oriented Training): 45 Subjects.

The Anthropometric measurements includes BMI, and Triceps Skin fold Thickness.

The Primary outcomes were Graded Wolf Motor Function test (Motor Functioning), Modified Nine Hole Peg Test with Auto Timer (Manual Dexterity) and Stroke Specific quality of Life ( HRQoL).

The Post test scores were taken after the period of 3 weeks. The Pre and Post-test were compared. Statistical Analysis were done using Paired, Unpaired ‘t’ tests,  Chi-square tests and ANOVA

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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • i BMI 24 to 29.9 ii Had a first episode of unilateral MCA stroke iii Both Ischemic and Hemorrhagic stroke iv Endocrine disorders like Diabetes, Hypertension v Sub acute stroke more than 3 months vi Person with dominant Hand involvement vii Brunnstrom score between stages II and III for the upper extremity viii Mini Mental State Examination score greater than or equal to 24 and 21 for illiterate ix Able to sit independently for 30 minutes.

排除标准

  • i Neurological disease (Parkinson’s disease, Alzhimer disease) ii Musculoskeletal problems (deformities, recent fracture, degenerative disorders) iii Any Systemic disease iv Pain (score 1 or at least 2 joints) v Aphasia vi Patients with severe somatosensory deficit vii Severe shoulder pain affecting therapy viii Any comorbid condition that could limit upper extremity function ix Visual or hearing impairment.
  • x Patients with repetitive stress injury xi Patients with Psychological problem.

结局指标

主要结局

1. Graded Wolf Motor Function Test (gWMFT)

时间窗: 2 years

2.Gross Manual Dexterity

时间窗: 2 years

(Modified 9-hole peg board test with Auto-timer)

时间窗: 2 years

3. Triceps Skin fold Thickness

时间窗: 2 years

4.HRQoL: Stroke Specific quality of life questionnaire

时间窗: 2 years

次要结局

  • HRQoL: Stroke Specific quality of life questionnaire

研究者

发起方
Mythili D
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mythili D

The Tamil Nadu Dr MGR Medical University Guindy

研究点 (1)

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