| CTRI Number |
CTRI/2025/07/091264 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PHENOMENOLOGICAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Life After Stroke Recovery: Survivors Experiences and Ongoing Needs After Physiotherapy. |
|
Scientific Title of Study
|
Lived Experience and Unmet Needs of Stroke Survivors After Physical Therapy Care: A Phenomenological Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUBHASISH CHATTERJEE |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8708660994 |
| Fax |
|
| Email |
subhasishphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUMAN PRADHAN |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8918151160 |
| Fax |
|
| Email |
pradhansuman451@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUMAN PRADHAN |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8918151160 |
| Fax |
|
| Email |
pradhansuman451@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, 133207 |
|
|
Primary Sponsor
|
| Name |
SUMAN PRADHAN |
| Address |
MAHARISHI MARKANDESWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION,MMDU, MULLANA, AMBALA, 133207, HARYANA, INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR SUMAN PRADHAN PT |
Room no. 06 Neuro OPD, MMIPR ,MM(DU), Mullana , Ambala,133207 |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA |
8918151160
pradhansuman451@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G93||Other disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Older adults having stroke(more than 6months).
Diagnosed with a first-ever or recurrent ischemic or haemorrhagic stroke.
Had any history of stroke or family member of someone with a stroke.
Able to communicate.
Residing in the community.
Barthel Index Score More than 60 (Mild-Moderated dependence or Independence in ADLs).
Stroke Impact Scale Score more than equal to 50 in the communication domain to ensure adequate ability to articulate experiences during interviews. |
|
| ExclusionCriteria |
| Details |
Communication problems due to aphasia or any other psychiatric problems.
Active psychiatric conditions (e.g schizophrenia, severe depression with psychosis).
Severe cognitive impairment (Mini-Mental State Examination [MMSE] score less than18).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Semi-Structured Interview using Interview Guide |
1st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Themes & Subthemes
2. Essence of Experience
3. Textual Descriptions |
5th day |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
06/08/2025 |
| 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="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background:Stroke is a significant global health issue, with India experiencing a stroke incidence rate of 108-172 per 100,000 people. By 2030, there will be 12 million stroke deaths, 70 million stroke survivors, and over 200 million lost worldwide. Stroke survivors face chronic disability, including physical disabilities and social impairments, and post-stroke depression affects survivors, family, and friends. Healthcare professionals must acknowledge the impact of stroke on a person’s life and explore cross-cultural differences in stroke conceptualization for up-scaling rehabilitation programs. Aim : To understand and explore the lived experiences and unmet needs of stroke survivors after Physical Therapy Care. Methods : In-depth semi-structured interviews will be conducted on 5 to 25 individuals with stroke who are community dwellers & are at least six month post-injury. Data will be collected till further no new themes are emerging i.e. till data saturation. Interviews will be audio or video recorded and transcribed verbatim in English. Analysis will be done according to six step process of Interpretative phenomenological analysis using an inductive approach and then entered into Qualitative data analysis tool- QDA miner Lite for analysis. Discussion : Care planning for stroke survivors requires an understanding of how individuals experience the illness. Through efficient therapeutic management, it is essential to reduce the elements impeding healing and strengthen those that promote it. The results may also help to improve current interventions and create comprehensive, multi-component rehabilitation plans that make recovery easier. Keywords : Stroke, Lived experience, unmet needs, Rehabilitation, Phenomenology, Qualitative |