| CTRI Number |
CTRI/2025/07/090361 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [efficacy of PDCA (Plan Do Check Act) based nursing intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of PDCA-based nursing intervention on activities of daily living in motor deficit patients due to neurological disorders |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Donna Lim |
| Designation |
PG Trainee |
| Affiliation |
College of Nursing, AFMC, Pune |
| Address |
College of Nursing, AFMC, Wanowrie, Pune, Maharashtra, PIN - 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
09136955675 |
| Fax |
|
| Email |
dnaa1242@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maj Lekshmi C L |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, AFMC, Pune |
| Address |
College of Nursing, AFMC, Wanowrie, Pune, Maharashtra, PIN - 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
7499592746 |
| Fax |
|
| Email |
cllekshmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DONNA LIM |
| Designation |
PG Trainee |
| Affiliation |
College of Nursing, AFMC, Pune |
| Address |
Colllege of Nursing, AFMC, Wanowrie, Pune, Maharashtra, PIN - 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
09136955675 |
| Fax |
|
| Email |
dnaa1242@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Southern Command, Wanowarie, Pune, Maharashtra, 411040 |
|
|
Primary Sponsor
|
| Name |
Donna Lim |
| Address |
College of Nursing, AFMC, Pune, Maharashtra, 411040 |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Asst Prof Lekshmi C L |
Command Hospital Southern Command Pune |
Neurosurgery Ward Command Hospital Southern Command Wanwadi Pune Maharashtra 411040
Pune
MAHARASHTRA |
7499592746
cllekshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Armed Forces Medical College Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G839||Paralytic syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients receiving Standard nursing interventions to improve ADL (Activities of daily living) |
Patients with motor deficit will receive routine standard nursing care regarding Activities of Daily Living over a period of 4 weeks |
| Intervention |
PDCA (Plan-Do-Check-Act)-Based Nursing Interventions to improve ADL (Activities of daily living) score |
Patients with motor deficit who are not able to perform ADL (Activities of daily living) independently, will be given PDCA (Plan-Do-Check-Act)-Based Nursing Interventions over a period of 4 weeks to improve ADL scores |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Motor Deficits - Patients exhibiting motor deficits (eg hemiparesis, paralysis, or muscle weakness) that significantly impact Activities of Daily Living (ADLs)
2. Age Adults aged 18 years and above.
3. Hospital Stay Patients admitted to the selected tertiary care hospital for treatment and rehabilitation.
4. Functional Limitation Patients experiencing difficulty in activities of daily living (ADLs) due to neurological impairment.
5. Consent - Patients who provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. 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.
2. Severe Cognitive Impairment, Patients with severe cognitive dysfunction (such as advanced dementia, unconscious patients, or those with profound intellectual disability) who cannot follow instructions.
3. Severe Comorbidities, that is patients with life-threatening comorbid conditions (such as end-stage organ failure, advanced malignancies) that could interfere with intervention participation.
4. Psychiatric Illness - patients with psychiatric disorders (such as schizophrenia, severe depression, or active psychosis) that may affect participation in ADL-based interventions.
5. 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.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Activities of Daily Living (ADLs) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. o Tool : Barthel Index for Activities of daily living (ADLs) o Motor function test: Fugl-Meyer Assessment (FMA)
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