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临床试验/CTRI/2025/07/090361
CTRI/2025/07/090361招募中不适用

A Randomized Controlled Trial to evaluate the efficacy of PDCA (Plan-Do-Check-Act)-Based Nursing Interventions in improving activities of daily living among patients with motor deficits Due to neurological disorders in a selected hospital in Maharashtra

Donna Lim1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年8月4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
44
试验地点
1
主要终点
Improvement in Activities of Daily Living (ADLs)

研究概览

简要总结

This study aims to assess the efficacy of a PDCA (Plan-Do-Check-Act)-based nursing intervention in improving ADLs among such patients. Conducted as a randomized controlled trial (RCT) in a selected hospital in Maharashtra, the study will compare outcomes between an intervention group receiving PDCA-based nursing care and a control group receiving standard care.

Participants will be randomly assigned to either group, and their ADLs will be evaluated using standardized assessment tools at baseline and post-intervention. The PDCA model will be implemented through a structured cycle

1. Plan (assessing patient needs and setting individualized goals)

2. Do (applying targeted nursing interventions)

3. Check (monitoring progress using standardized ADL assessment tools), and

**4.**Act (refining interventions based on feedback). The study will be conducted in a selected hospital in Maharashtra with a total of 44 patients, where 22 patients with neurological disorders and motor deficits that are undergoing treatment will be given PDCA-Based Nursing Approach and the other 22 will belong to the control group.

INSTRUMENT/ DATA COLLECTING TOOL

·       For pre-test assessment will be done using the Barthel Index to assess ADL before intervention. Selected demographic variables such as- age, gender, educational qualification, family income and diagnosis will also be included.

·       Administration of PDCA-based nursing interventions on activities of daily living (ADLs) in patients with motor deficits due to neurological disorders.

·       Assessment via Barthel Index post intervention.

Demographic Variables :Demographic variables includes Age, Gender, Educational qualification and economic status.

Clinical Variables : Clinical variables include- diagnosis and length of hospital stay.

Tool: Barthel Index for Activities of daily living (ADLs)

Motor function test: Fugl-Meyer Assessment (FMA)

研究设计

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

入排标准

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

入选标准

  • Motor Deficits.
  • Patients exhibiting motor deficits (eg hemiparesis, paralysis, or muscle weakness) that significantly impact Activities of Daily Living (ADLs)
  • Age Adults aged 18 years and above.
  • Hospital Stay Patients admitted to the selected tertiary care hospital for treatment and rehabilitation.
  • Functional Limitation Patients experiencing difficulty in activities of daily living (ADLs) due to neurological impairment.
  • Patients who provide written informed consent to participate in the study.

排除标准

  • Acute or Severe Stages of Neurological Disorders.
  • Patients in the acute phase of a neurological event (within 72 hours of a stroke or head injury) where their condition is unstable and likely to prevent meaningful participation.
  • Severe Cognitive Impairment, Patients with severe cognitive dysfunction (such as advanced dementia, unconscious patients, or those with profound intellectual disability) who cannot follow instructions.
  • Severe Comorbidities, that is patients with life-threatening comorbid conditions (such as end-stage organ failure, advanced malignancies) that could interfere with intervention participation.
  • Psychiatric Illness.
  • patients with psychiatric disorders (such as schizophrenia, severe depression, or active psychosis) that may affect participation in ADL-based interventions.
  • Severe Visual or Hearing Impairment: Patients with significant sensory impairments (such as blindness or profound hearing loss) that may hinder their ability to participate in rehabilitation exercises, interact with caregivers, or engage in ADL tasks.

结局指标

主要结局

Improvement in Activities of Daily Living (ADLs)

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方
Donna Lim
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Donna Lim

College of Nursing, AFMC, Pune

研究点 (1)

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